97. 潰瘍性大腸炎 ［臨床試験数：820，薬物数：887（DrugBank：195），標的遺伝子数：108，標的パスウェイ数：166］
Searched query = "Ulcerative colitis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03996369 | June 2020 | 15 July 2019 | Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 12-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod;Drug: Placebo | Arena Pharmaceuticals | Not recruiting | 16 Years | 80 Years | All | 330 | Phase 3 | ||
| 2 | NCT04096573 | April 2020 | 30 September 2019 | Efficacy and Safety of LC51-0255 in Subjects With Ulcerative Colitis | A Phase 2, Multi Center, Randomized, Placebo Controlled Parallel Group Study to Evaluate the Clinical Efficacy and Safety of LC51 0255 in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: LC51-0255;Drug: Placebo | LG Chem | Not recruiting | 18 Years | 80 Years | All | 240 | Phase 2 | ||
| 3 | NCT04074590 | December 13, 2019 | 4 November 2019 | Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis | A Randomized, Multi-center, Subject and Investigator-blinded, Placebo-controlled, Parallel-group Study to Assess the Efficacy Safety and Tolerability of LYS006 in Patients With Mild to Moderate Ulcerative Colitis | Colitis, Ulcerative | Drug: LYS006;Drug: Placebo | Novartis Pharmaceuticals | Not recruiting | 18 Years | 65 Years | All | 60 | Phase 2 | ||
| 4 | NCT04004611 | December 12, 2019 | 11 November 2019 | A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC) | Multicenter, Open-Label PK Study of Mirikizumab in Pediatric Patients With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Mirikizumab | Eli Lilly and Company | Not recruiting | 2 Years | 17 Years | All | 30 | Phase 2 | ||
| 5 | JPRN-JapicCTI-194980 | 02/12/2019 | 7 October 2019 | A Study of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Intervention name : Guselkumab INN of the intervention : Guselkumab Dosage And administration of the intervention : Induction Study 1: Guselkumab Dose 1, Induction Study 1: Guselkumab Dose 2, Induction Study 1: Guselkumab Dose 3, Induction Study 2: Guselkumab IV; Maintenance Study: Maintenance Dose Regimen 1, Maintenance Study: Maintenance Dose Regimen 2; Participants will receive guselkumab IV or SC. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Induction Study 1: Placebo IV Induction, Study 2: Placebo IV Maintenance Study: Placebo SC; Participants will receive matching placebo IV or SC. | Janssen Pharmaceutical K.K. | Not Recruiting | 18 | BOTH | 1000 | Phase 2-3 | Japan, Asia except Japan, North America, Europe | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | ChiCTR1900025900 | 2019-12-01 | 16 September 2019 | Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial. | Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial. | Ulcerative colitis | Experimental group:Mesalazine+DHEP II;control group:Mesalazine+Compound Huangbai lotion; | Nanjing Hospital of Chinese Medicine | Not Recruiting | Both | Experimental group:200;control group:100; | Phase 3 | China | |||
| 7 | NCT02277223 | December 1, 2019 | 30 September 2019 | Curcumin in Pediatric Ulcerative Colitis | Curcumin for Induction and Maintenance Therapy in Pediatric Ulcerative Colitis | Ulcerative Colitis | Dietary Supplement: Curcumin;Drug: Placebo | Schneider Children's Medical Center, Israel | Not recruiting | 6 Years | 18 Years | All | 60 | Phase 3 | ||
| 8 | NCT03998488 | December 2019 | 11 November 2019 | Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Dietary Fiber in Patients With Ulcerative Colitis | A Randomized, Placebo-controlled Clinical Trial Examining the Efficacy of Fecal Microbiota Transplantation (FMT) and Subsequent Dietary Fiber in Patients With Moderate Ulcerative Colitis | Ulcerative Colitis;Inflammatory Bowel Diseases | Drug: Fecal Microbiota Transplantation;Dietary Supplement: Psyllium Husk Powder | Weill Medical College of Cornell University | Crohn's and Colitis Foundation | Recruiting | 18 Years | 89 Years | All | 135 | Phase 2 | United States |
| 9 | NCT04090411 | November 22, 2019 | 30 September 2019 | A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Ulcerative Colitis | A PHASE 2B, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE-RANGING STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PF-06480605 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Moderate to Severe Ulcerative Colitis | Drug: 50 mg;Drug: 450 mg;Drug: 150 mg;Other: 0 mg | Pfizer | Not recruiting | 18 Years | 75 Years | All | 240 | Phase 2 | ||
| 10 | NCT04133194 | November 1, 2019 | 4 November 2019 | Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis | Adherence of a 1.600 mg Single Tablet 5-ASA Treatment of Ulcerative Colitis (EASI-trial) | Ulcerative Colitis | Drug: Mesalazine | Copenhagen University Hospital, Hvidovre | Not recruiting | 18 Years | 60 Years | All | 200 | Phase 4 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT04156984 | November 2019 | 11 November 2019 | Comparison of Two Different Golimumab Dosing Regimens for Ulcerative Colitis | Exposure-response of Golimumab During Maintenance in Ulcerative Colitis: An Exploratory Pharmacokinetics/Pharmacodynamics Comparison of Different Dose Regimens | Ulcerative Colitis | Drug: Golimumab Prefilled Syringe | David Drobne | Not recruiting | 18 Years | 65 Years | All | 30 | Phase 4 | Slovenia | |
| 12 | NCT03414788 | October 15, 2019 | 15 July 2019 | Distribution of a Single IV Dose Of [124I]-Pf 06687234 and Pf 06687234 Assessed With PET-CT Imaging In Moderate To Severe Ulcerative Colitis | PHASE 1B, OPEN LABEL STUDY TO CHARACTERIZE THE DISTRIBUTION OF A SINGLE INTRAVENOUS DOSE OF [124I]-IODOBENZOYL (IB) PF 06687234 WITH CONCURRENT ADMINISTRATION OF NON-RADIOLABELED PF 06687234 AS ASSESSED WITH POSITRON EMISSION TOMOGRAPHY AND COMPUTED TOMOGRAPHY (PET-CT) IMAGING IN MODERATE TO SEVERE ULCERATIVE COLITIS SUBJECTS | Ulcerative Colitis | Biological: PF 06687234;Biological: [124I]IB PF 06687234 | Pfizer | Not recruiting | 18 Years | 75 Years | All | 5 | Phase 1 | United States | |
| 13 | NCT03802214 | October 14, 2019 | 22 October 2019 | Ulcerative Colitis - Vedolizumab- With/Without Prior Exposure to Anti-TNF(Tumor Necrosis Factor)Therapy | A Case-control Study to Evaluate the Immunoinflammatory Effect of Prior Exposure to Anti-TNF Therapy in Patients With Ulcerative Colitis Starting Vedolizumab Therapy | Ulcerative Colitis | Drug: Vedolizumab | Stanford University | Takeda;University of Western Ontario, Canada;University of California, San Diego | Not recruiting | 18 Years | N/A | All | 20 | Phase 3 | |
| 14 | NCT03920254 | October 2019 | 4 November 2019 | TD-1473 Long-Term Safety (LTS) Ulcerative Colitis (UC) Study | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects With Ulcerative Colitis (UC) | Ulcerative Colitis (UC) | Drug: TD-1473 Dose A;Drug: TD-1473 Dose B;Drug: TD-1473 Dose C | Theravance Biopharma | Not recruiting | 18 Years | N/A | All | 500 | Phase 2/Phase 3 | United States;Bulgaria;Georgia;Greece;Hungary;Israel;Poland;Portugal;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine | |
| 15 | NCT04006977 | October 2019 | 30 September 2019 | Multistrain Probiotics Reduces UC Depression and Anxiety Scores | Multistrain Probiotic Product (De Simone Formulation) Reduces Depression and Anxiety Scores: a Randomized Pilot Study in Patients With Ulcerative Colitis | Ulcerative Colitis | Dietary Supplement: a multistrain probiotic product (DSF);Dietary Supplement: Placebo | Xijing Hospital of Digestive Diseases | MENDES SA | Not recruiting | 18 Years | 65 Years | All | 60 | N/A | China |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT04023396 | October 2019 | 29 July 2019 | Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis | A Phase 2b, Open-label, Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: ABX464 | Abivax S.A. | Not recruiting | 18 Years | 75 Years | All | 210 | Phase 2 | ||
| 17 | NCT04130919 | October 2019 | 28 October 2019 | Study to Evaluate the Efficacy and Safety of GS-4875 in Adults With Moderately to Severely Active Ulcerative Colitis | A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of GS-4875 in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: GS-4875;Drug: Placebo | Gilead Sciences | Not recruiting | 18 Years | N/A | All | 180 | Phase 2 | ||
| 18 | NCT04131322 | October 2019 | 28 October 2019 | Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease. | Loss of Response of Adalimumab Biosimilar Compared With the Loss of Response of Adalimumab Original: Controlled, Randomized, Non-inferiority Open Study. ADA-SWITCH Study | Crohn Disease;Ulcerative Colitis | Drug: Amgevita 40Mg Solution for Injection;Drug: HUMIRA 40Mg Solution for Injection | Fundación Pública Andaluza para la gestión de la Investigación en Sevilla | Not recruiting | 18 Years | N/A | All | 216 | Phase 4 | ||
| 19 | NCT04102852 | September 30, 2019 | 7 October 2019 | Lactobacillus Rhamnosus GG (ATCC 53103) in Mild-moderately Active UC Patients | The Role of Lactobacillus Rhamnosus GG (ATCC 53103) in the Modulation of the Inflammatory Process in the Mucosa of Ulcerative Colitis (UC) Patients With Mild-moderate Clinical Activity | Ulcerative Colitis Chronic Mild;Ulcerative Colitis Chronic Moderate | Dietary Supplement: Lactobacillus rhamnosus GG ATCC 53103 | San Giovanni Addolorata Hospital | Onlus S. Andrea | Not recruiting | 18 Years | 65 Years | All | 80 | Phase 1/Phase 2 | Italy |
| 20 | NCT04033445 | September 26, 2019 | 22 October 2019 | A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2b/3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Guselkumab;Drug: Placebo | Janssen Research & Development, LLC | Recruiting | 18 Years | N/A | All | 1000 | Phase 2/Phase 3 | United States;Argentina;Australia;Belgium;Bulgaria;Canada;China;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Netherlands;Poland;Portugal;Spain;Sweden;Turkey;Ukraine;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | NCT03847467 | September 20, 2019 | 22 October 2019 | Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in IBD Patients Receiving Stable Maintenance Anti-TNF Therapy | Pilot and Feasibility Study of 2'-FL as a Dietary Supplement in Pediatric and Young Adult IBD Patients Receiving Stable Maintenance Anti-TNF Therapy | Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis | Drug: 2'-Fucosyllactose;Other: Placebo | Children's Hospital Medical Center, Cincinnati | Broad Institute;University of Cincinnati;Connecticut Children's Medical Center | Recruiting | 11 Years | 25 Years | All | 216 | Phase 1/Phase 2 | United States |
| 22 | NCT03950232 | September 20, 2019 | 11 November 2019 | An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | An Open-Label Extension Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod | Arena Pharmaceuticals | Recruiting | 16 Years | 80 Years | All | 702 | Phase 3 | United States | |
| 23 | NCT03885713 | September 10, 2019 | 4 November 2019 | Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease | Identification of Predictive Biomarkers for Response to Biologic Therapies in Inflammatory Bowel Disease by Proteomic and Mass Cytometry Approaches | Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis | Biological: Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Recruiting | 18 Years | N/A | All | 180 | Phase 4 | Spain | |
| 24 | NCT03980405 | September 2019 | 17 June 2019 | Combination of Diet and 5ASA ( 5-aminosalicylic Acid) for Ulcerative Colitis | Combination Therapy With Drug and Diet for Induction of Remission in Mild to Moderate Active Pediatric Ulcerative Colitis: A Single Blinded, International Randomized Controlled Trial | Ulcerative Colitis | Dietary Supplement: Group 1- Control Diet;Dietary Supplement: Group 2- UCD Diet | Prof. Arie Levine | Not recruiting | 10 Years | 19 Years | All | 62 | N/A | ||
| 25 | NCT04064697 | September 2019 | 16 September 2019 | Impact of Anti-cytomegalovirus (Valganciclovir) Treatment in the Management of Relapsing Ulcerative Colitis (UC) Requiring Vedolizumab Therapy | Impact of Anti-cytomegalovirus (Valganciclovir) Treatment in the Management of Relapsing Ulcerative Colitis (UC) Requiring Vedolizumab Therapy: a Randomized Clinical Trial Comparing a Strategy With or Without Antiviral Therapy. CYTOVEDO Study | Ulcerative Colitis, Unspecified | Drug: Valganciclovir | Centre Hospitalier Universitaire de Saint Etienne | Ministry of Health, France | Not recruiting | 18 Years | N/A | All | 120 | Phase 3 | France |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | NCT03724175 | August 26, 2019 | 4 November 2019 | The Role of Secondary Bile Acids in Intestinal Inflammation | The Role of Secondary Bile Acids in Intestinal Inflammation | Ulcerative Colitis;Pouchitis | Drug: ursodiol (ursodeoxycholic acid, UDCA) | Stanford University | Recruiting | 18 Years | 70 Years | All | 15 | Phase 2/Phase 3 | United States | |
| 27 | NCT03861143 | August 14, 2019 | 2 September 2019 | Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | A Randomized , Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: BT-11 (500 mg);Drug: BT-11 (1000 mg);Drug: Placebo | Landos Biopharma Inc. | Recruiting | 18 Years | 65 Years | All | 195 | Phase 2 | United States | |
| 28 | NCT03869905 | August 8, 2019 | 26 August 2019 | Aquamin® as an Adjuvant Intervention for Ulcerative Colitis In Remission | Aquamin®, a Multi-mineral Natural Product From Red Marine Algae, as an Adjuvant Intervention for Ulcerative Colitis in Remission | Ulcerative Colitis | Drug: Aquamin®;Drug: Placebo first then Aquamin® | James Varani | Recruiting | 18 Years | 80 Years | All | 40 | Phase 2 | United States | |
| 29 | ChiCTR1900024086 | 2019-08-01 | 1 July 2019 | Modified Chinese Medicine Granule in the Treatment of Ulcerative Colitis in the Remission Phase: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Controlled Trials | Modified Chinese Medicine Granule in the Treatment of Ulcerative Colitis in the Remission Phase: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Controlled Trials | Ulcerative Colitis | intervention period:Modified Chinese Medicine Granule and Mesalazine placebo;control period:Mesalazine and Modified Chinese Medicine Granule placebo; | The First Affiliated Hospital of Guangzhou University of Chinese Medicine | Not Recruiting | 18 | 75 | Both | intervention period:10;control period:10; | N/A | China | |
| 30 | NCT04029649 | August 2019 | 29 July 2019 | Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Ulcerative Colitis | The Role of Beta-1,3/1,6-D-Glucan From Mycelium Extract of Ganoderma Lucidum on Ulcerative Colitis: A Double-Blind Randomized Controlled Trial | Ulcerative Colitis | Drug: Beta-1,3/1,6-D-Glucan;Drug: Placebo | Fakultas Kedokteran Universitas Indonesia | Not recruiting | 18 Years | N/A | All | 204 | Phase 2/Phase 3 | Indonesia | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | NCT03591770 | July 31, 2019 | 26 August 2019 | Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib | The Immunogenicity and Safety of Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib | Inflammatory Bowel Diseases | Biological: SHINGRIX | Boston Medical Center | Recruiting | 50 Years | N/A | All | 100 | Phase 4 | United States | |
| 32 | NCT03948919 | July 31, 2019 | 26 August 2019 | Low Sulfur Fecal Transplant for Ulcerative Colitis | Low Sulfur Fecal Transplant for Ulcerative Colitis | Ulcerative Colitis | Drug: Fecal microbiota;Other: Placebo | University of Minnesota - Clinical and Translational Science Institute | Recruiting | 18 Years | 89 Years | All | 20 | Phase 1 | United States | |
| 33 | ChiCTR1900024591 | 2019-07-22 | 22 July 2019 | Clinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitis | Clinical evaluation for traditional Chinese medicine in the treatment of severe active ulcerative colitis | Ulcerative colitis | TCM Group:Prednisone+New Wumeiwan Formula;Convenience medicine Group:Prednisone+Mesalazine Enteric-coated tablets (Salofalk);Combined Group:Prednisone+New Wumeiwan Formula+Mesalazine Enteric-coated tablets(Salofalk); | Peking University First Hospital | Not Recruiting | 18 | 65 | Both | TCM Group:40;Convenience medicine Group:40;Combined Group:40; | Phase 0 | China | |
| 34 | NCT04030676 | July 17, 2019 | 29 July 2019 | QuantiFERON-CMV Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis | Place of the QuantiFERON-CMV (QF-CMV) Test in a Prediction for Colic Cytomegalovirus Reactivation During Ulcerative Colitis (UC) | Cytomegalovirus Infections | Procedure: Biopsies;Biological: Blood samples | Centre Hospitalier Universitaire de Saint Etienne | Recruiting | 18 Years | N/A | All | 196 | N/A | France | |
| 35 | NCT03937609 | July 15, 2019 | 22 July 2019 | TITRATE (inducTIon for acuTe ulceRATivE Colitis) | Randomized, Multicenter Study to Investigate the Efficacy of Dashboard Driven Individualized Dosing of Infliximab Compared To Standard Dosing During the Induction in Patients With Acute Severe Ulcerative Colitis | Colitis, Ulcerative | Drug: Infliximab | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Pfizer | Recruiting | 18 Years | N/A | All | 120 | Phase 4 | Netherlands |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | NCT04018599 | July 15, 2019 | 30 September 2019 | Comparison of PK and Tolerability of MSB11022 Administered by AI or PFS | A Phase I, Randomized, Open-label, Parallel-group Study to Determine the Pharmacokinetics, Safety, and Tolerability of MSB11022 (Proposed Adalimumab Biosimilar) Following a Single Subcutaneous Injection by an Auto-injector or by a Pre-filled Syringe in Healthy Subjects | Rheumatoid Arthritis;Polyarticular Juvenile Idiopathic Arthritis;Psoriatic Arthritis;Ankylosing Spondylitis;Crohn Disease;Ulcerative Colitis;Plaque Psoriasis;Pediatric Plaque Psoriasis;Pediatric Crohns Disease;Hidradenitis Suppurativa;Non-infectious Uveitis | Drug: 40 mg MSB11022 | Fresenius Kabi SwissBioSim GmbH | PRA Health Sciences | Recruiting | 18 Years | 55 Years | All | 216 | Phase 1 | United States |
| 37 | NCT03935451 | July 1, 2019 | 13 May 2019 | Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel Disease | A Randomized Controlled Trial on the Use of Postoperative Extended Venous Thromboprophylaxis in Patients With Inflammatory Bowel Disease: A Pilot Study | IBD;Venous Thromboembolism;Crohn Disease;Ulcerative Colitis;Pulmonary Embolism;Colorectal Disorders | Drug: Apixaban 2.5 milligram;Drug: Placebo Oral Tablet | McMaster University | Not recruiting | 18 Years | N/A | All | 180 | Early Phase 1 | ||
| 38 | NCT04006080 | July 1, 2019 | 15 July 2019 | Investigation of the Faecal Loss of Vedolizumab and Its Role in Influencing Serum Drug Levels, Outcomes and Response in Ulcerative Colitis | Investigation of the Faecal Loss of Vedolizumab and Its Role in Influencing Serum Drug Levels, Outcomes and Response in Ulcerative Colitis | Ulcerative Colitis | Biological: Vedolizumab | Guy's and St Thomas' NHS Foundation Trust | Takeda | Recruiting | 18 Years | N/A | All | 30 | Phase 4 | United Kingdom |
| 39 | NCT03986996 | July 2019 | 24 June 2019 | Antimicrobial Therapy for Ulcerative Colitis (UC) | Antimicrobial Therapy for Ulcerative Colitis : Evaluation of Two Antibiotic Combinations for Refractory Ulcerative Colitis | Ulcerative Colitis | Drug: amoxicillin, metronidazole and tetracycline;Drug: amoxicillin and tetracycline | Wolfson Medical Center | Not recruiting | 13 Years | 60 Years | All | 40 | Phase 2 | Israel | |
| 40 | NCT03656627 | June 27, 2019 | 22 October 2019 | Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease | Safety, Activity, and Pharmacology of Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer and Pre-existing Autoimmune Disease | Autoimmune Diseases;Non-small Cell Lung Cancer;Rheumatoid Arthritis;Psoriasis;Giant Cell Arteritis;Polymyalgia Rheumatica;Systemic Lupus Erythematosus;Crohn Disease;Multiple Sclerosis;Ulcerative Colitis | Drug: Nivolumab | Alliance Foundation Trials, LLC. | Bristol-Myers Squibb | Recruiting | 18 Years | N/A | All | 72 | Phase 1 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | NCT03923478 | June 24, 2019 | 2 September 2019 | ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 1b Study to Evaluate the Safety, Efficacy and Mircobiological Response of Oral ABI-M201 in Subjects With Mildly-to-Moderately Active UC With Ongoing Mesalamine Treatment | Ulcerative Colitis Chronic Mild;Ulcerative Colitis Chronic Moderate | Drug: ABI-M201;Drug: Placebo | Assembly Biosciences | Allergan | Recruiting | 18 Years | 70 Years | All | 44 | Phase 1 | United States |
| 42 | NCT03483246 | June 18, 2019 | 14 October 2019 | Impact of Fecal Microbiota Transplantation in Ulcerative Colitis | Impact of Fecal Microbiota Transplantation in Ulcerative Colitis: a Randomized, Sham Controlled Trial | Ulcerative Colitis | Drug: Fecal Microbiota Transplantation (FMT);Drug: Sham-transplantation Placebo | Assistance Publique - Hôpitaux de Paris | CRB-HUEP;Institut National de la Santé Et de la Recherche Médicale, France | Recruiting | 18 Years | 75 Years | All | 150 | Phase 3 | France |
| 43 | NCT03945188 | June 13, 2019 | 11 November 2019 | Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Assess the Efficacy and Safety of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod;Drug: Placebo | Arena Pharmaceuticals | Recruiting | 16 Years | 80 Years | All | 372 | Phase 3 | United States;Belgium;Croatia;Estonia;Georgia;Hungary;Korea, Republic of;Latvia;Lithuania;Moldova, Republic of;Slovakia;South Africa | |
| 44 | NCT03760003 | June 11, 2019 | 24 June 2019 | Dose-Ranging Phase 2b Study of ABX464 in Moderate to Severe Ulcerative Colitis | A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Dose, Induction Study to Evaluate the Safety, Tolerability and Optimal Dose of ABX464 Compared With Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Have Inadequate Response, Loss of Response, or Intolerance With at Least One of the Following Agents: Immunosuppressant Treatment (i.e. Azathioprine, 6-mercaptopurine, Methotrexate), Tumor Necrosis Factor Alpha [TNF-a] Inhibitors, Vedolizumab, JAK Inhibitors and/or Corticosteroid Treatment | Ulcerative Colitis | Drug: ABX464 25mg;Drug: ABX464 50mg;Drug: ABX464 100mg;Drug: Placebo | Abivax S.A. | Recruiting | 18 Years | 75 Years | All | 252 | Phase 2 | Poland | |
| 45 | NCT03915769 | June 3, 2019 | 28 October 2019 | To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | A Phase 2/3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of Oral Ozanimod to Evaluate Efficacy and Long-term Safety in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Ozanimod;Other: Placebo | Celgene | Recruiting | 18 Years | 75 Years | All | 195 | Phase 3 | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | NCT03941418 | June 1, 2019 | 11 June 2019 | Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease | Impact of Additional Treatment With Saccharomyces Boulardii on Quality of Life in Patients With Mild Forms of Ulcerative Colitis and Crohn Disease | Ulcerative Colitis;Crohn Disease | Dietary Supplement: Boulardii;Dietary Supplement: Placebo | University Clinic Dr Dragisa Misovic-Dedinje | University Clinic Zvezdara | Not recruiting | 18 Years | 80 Years | All | 150 | N/A | |
| 47 | NCT03977480 | June 1, 2019 | 17 June 2019 | Phase II Study of Hemay007 in Patients With Active Ulcerative Colitis | A Multicenter, Randomized, Double-blind, Placebo Parallel Controlled Clinical Study on the Effecacy and Safety of Different Dosing Regimens of Hemay007 in Patients With Active Ulcerative Colitis | Ulcerative Colitis | Drug: Hemay007;Drug: Placebo | Tianjin Hemay Pharmaceutical Co.,Ltd | Not recruiting | 18 Years | 70 Years | All | 288 | Phase 2 | China | |
| 48 | NCT03798691 | May 28, 2019 | 15 July 2019 | Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab | A Pilot Study Evaluating Immunogenicity of Herpes Zoster Subunit Vaccine in Inflammatory Bowel Disease Patients Treated With Vedolizumab | Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis;Herpes Zoster | Biological: Shingrix | University of Wisconsin, Madison | Boston Medical Center | Recruiting | 50 Years | 70 Years | All | 30 | Phase 4 | United States |
| 49 | ChiCTR1900023158 | 2019-05-20 | 20 May 2019 | Clinical evaluation of traditional Chinese medicine on mild active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial | Clinical evaluation of traditional Chinese medicine on mild active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial | Ulcerative colitis | TCM Group:Hudi Enteric-coated Capsules+Mesalazine Enteric-coated Tablets(Salofalk)Simulator;Medical Group:Mesalazine Enteric-coated Tablets(Salofalk)+Hudi Enteric-coated Capsules Simulator; | Jiangsu Province Hospital of Chinese Medicine | Recruiting | 18 | 65 | Both | TCM Group:120;Medical Group:120; | Phase 4 | China | |
| 50 | ChiCTR1900023159 | 2019-05-20 | 20 May 2019 | Clinical evaluation of traditional Chinese medicine on moderate active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial | Clinical evaluation of traditional Chinese medicine on moderate active ulcerative colitis: a multi-center, randomized, double-blind, controlled trial | Ulcerative colitis | ?????????+???????(???)???:Qingchang Wenzhong Granules+Mesalazine Enteric-coated Tablets(Salofalk)Simulator;Medical Group:Mesalazine Enteric-coated Tablets(Salofalk)+Qingchang Wenzhong Granules Simulator;Combined Group:Qingchang Wenzhong Granules+Mesalazine Enteric-coated Tablets(Salofalk); | Dongfang Hospital of Beijing University of Chinese Medicine | Recruiting | 18 | 65 | Both | ?????????+???????(???)???:90;Medical Group:90;Combined Group:90; | Phase 0 | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | NCT03917095 | May 15, 2019 | 27 May 2019 | The Safety and Efficacy of TET Enema in the Treatment of UC | Mesalazine and Compound Glutamin Enema for the Treatment of Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing: A Multicenter, Randomized, Controlled Trail | Ulcerative Colitis Chronic Mild;Ulcerative Colitis Chronic Moderate | Drug: Mesalazine;Drug: Glutamine;Device: The Colonic Transendoscopic enteral Tubing. | The Second Hospital of Nanjing Medical University | Recruiting | 18 Years | 65 Years | All | 75 | N/A | China | |
| 52 | NCT03943550 | May 8, 2019 | 20 May 2019 | Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Patients With Ulcerative Colitis (UC) | A Multicenter, Randomized, Double-Blind, Placebo Controlled Phase Ib Study to Investigate the Safety, Tolerability, Pharmacokinetics, Preliminary Efficacy, and Pharmacodynamics of Subcutaneously Administered RO7049665 in Participants With Active Ulcerative Colitis | Ulcerative Colitis | Drug: RO7049665;Drug: Placebo | Hoffmann-La Roche | Recruiting | 18 Years | 70 Years | All | 50 | Phase 1 | United States;Georgia;Hungary;Moldova, Republic of;Ukraine | |
| 53 | NCT03893565 | May 6, 2019 | 11 November 2019 | Safety, Tolerability, Efficacy and Dose-response of GSK2831781 in Ulcerative Colitis | A Multicentre Randomized, Double-blind (Sponsor Open), Placebo-controlled Phase 2 Study to Evaluate the Safety, Tolerability, Efficacy, Dose-response, Pharmacokinetics and Pharmacodynamics of Repeat Dosing of an Anti-LAG3 Cell Depleting Monoclonal Antibody (GSK2831781) in Patients With Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Placebo;Biological: GSK2831781 | GlaxoSmithKline | Recruiting | 18 Years | N/A | All | 280 | Phase 2 | United States;Bulgaria;Czechia;Estonia;France;Netherlands;Poland;Slovakia;South Africa;United Kingdom | |
| 54 | NCT03843385 | May 2019 | 4 March 2019 | Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis | Longterm Transfer of FRozen Encapsulated Multidonor Stool Filtrate or Encapsulated Multidonor Microbiome for Chronic Active Ulcerative COlitis | Ulcerative Colitis;Inflammatory Bowel Diseases | Drug: encapsulated faecal microbiota filtrate;Drug: encapsulated faecal microbiota;Drug: Placebo | Jena University Hospital | German Federal Ministry of Education and Research | Not recruiting | 18 Years | 75 Years | All | 174 | Phase 2/Phase 3 | |
| 55 | NCT03934216 | April 26, 2019 | 11 November 2019 | Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis (UC) | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: BMS-986165;Drug: Placebo | Bristol-Myers Squibb | Recruiting | 18 Years | 80 Years | All | 120 | Phase 2 | United States;Australia;Belgium;Canada;Czechia;Germany;Hungary;Italy;Japan;Korea, Republic of;Poland;Russian Federation;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | NCT03860896 | April 24, 2019 | 26 August 2019 | GB004 in Adult Subjects With Active Ulcerative Colitis | A Phase 1b, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GB004 in Adult Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Drug: GB004;Drug: Placebo | GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. | Recruiting | 18 Years | 74 Years | All | 30 | Phase 1 | United States;Georgia;Moldova, Republic of | |
| 57 | NCT03800420 | April 22, 2019 | 4 November 2019 | Efficacy and Safety of BBT-401-1S in Ulcerative Colitis | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of BBT-401-1S in Patients With Active Ulcerative Colitis | Ulcerative Colitis | Drug: Active group;Drug: Placebo group | Bridge Biotherapeutics, Inc. | KCRN Research, LLC | Recruiting | 18 Years | N/A | All | 48 | Phase 2 | United States |
| 58 | NCT03675477 | April 13, 2019 | 14 October 2019 | A Phase II Study in Patients With Moderate to Severe Active Ulcerative Colitis. | A Phase II Randomized, Placebo Controlled, Double-blind, 4 Arms Dose-ranging Study to Evaluate the Efficacy and Safety of SHR0302 Compared to Placebo in Patients With Moderate to Severe Active Ulcerative Colitis. | Ulcerative Colitis | Drug: SHR0302;Drug: Placebos | Reistone Biopharma Company Limited | Recruiting | 18 Years | 75 Years | All | 152 | Phase 2 | United States;China;Poland;Ukraine | |
| 59 | EUCTR2018-002135-19-HU | 11/04/2019 | 30 April 2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Ulcerative Colitis (UC) | A 3-Year, Multi-Center, Long-Term Safety (LTS) Study to Evaluate the Safety and Tolerability of TD-1473 in Subjects with Ulcerative Colitis (UC) - TD-1473 LTS UC Study | Moderately-to-severely active Ulcerative Colitis (UC) MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 Pharmaceutical Form: Coated tablet INN or Proposed INN: Not assigned Current Sponsor code: TD-1473 Other descriptive name: THRX-139060 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Product Name: TD-1473 Product Code: TD-1473 Pharmaceutical Form: Coated tablet INN or Proposed INN: Not assigned Current Sponsor code: TD-1473 Other descriptive name: THRX-139060 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Product Name: TD-1473 Product Code: TD-1473 Pharmaceutical Form: Coated tablet INN or Proposed INN: Not assigned Current Sponsor code: TD-1473 Other descriptive name: THRX-139060 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Theravance Biopharma Ireland Limited | Authorised | Female: yes Male: yes | 500 | Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;France;Hungary;Canada;Poland;Croatia;Australia;Georgia;South Africa;Bulgaria;Germany | |||
| 60 | NCT03816345 | April 4, 2019 | 11 November 2019 | Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable Cancer | A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO) | Advanced Malignant Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Inflammatory Bowel Disease;Metastatic Malignant Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant Neoplasm | Biological: Nivolumab | National Cancer Institute (NCI) | Recruiting | 18 Years | N/A | All | 264 | Phase 1 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | ChiCTR1900022243 | 2019-04-01 | 1 April 2019 | Effect of curcumin combined with probiotics on prevention and treatment in ileal pouchitis after operation of ulcerative colitis. | Effect of curcumin combined with probiotics on prevention and treatment in ileal pouchitis after operation of ulcerative colitis. | ileal pouchitis after operation of ulcerative colitis | Experimental group:Curcumin+Probiotics;Control group:Probiotics; | Tianjin Medical University General Hospital | Recruiting | Both | Experimental group:20;Control group:10; | Phase 0 | China | |||
| 62 | NCT03794765 | April 1, 2019 | 15 April 2019 | Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis | Use of Antibiotics as an Adjuvant in Patients With Acute Severe Ulcerative Colitis: A Randomised Trial | Ulcerative Colitis;Inflammatory Bowel Diseases;Acute Severe Colitis | Drug: Ceftriaxone;Drug: Metronidazole;Other: Placebo infusion | Postgraduate Institute of Medical Education and Research | Recruiting | 13 Years | N/A | All | 50 | Phase 2 | India | |
| 63 | NCT04000139 | April 1, 2019 | 28 October 2019 | Anthocyanin Rich Extract (ACRE) in Patients With Ulcerative Colitis | A Multi-center, Multi-national, Randomized, Double-blind, Placebo Controlled, Parallel Group, Phase IIa Study to Evaluate the Efficacy, Safety and Tolerability of an Anthocyanin-rich Extract (ACRE) in Patients With Ulcerative Colitis | Ulcerative Colitis | Drug: Standardized anthocyanin-rich extract;Drug: Placebo | University of Zurich | Swiss National Science Foundation;The Broad Foundation | Recruiting | 18 Years | N/A | All | 120 | Phase 2 | Switzerland |
| 64 | NCT04057547 | April 1, 2019 | 28 October 2019 | Efficacy and Safety of Modified Gegen Qinlian Decoction for Ulcerative Colitis With Damp-heat Syndrome | The Correlation Within Dampness-heat Syndrome of Ulcerative Colitis(UC) and Intestinal Microbiota Via C1orf106/Cytohesin-1(CYTH-1) /Adenosine Diphosphate-ribosylation Factor 6(ARF6) Signal Pathway and the Intervention Mechanism of Classic Chinese Compound Formula With Clearing Heat and Promoting Dieresis | Ulcerative Colitis | Drug: Modified Gegen Qinlian Decoction | Xiyuan Hospital of China Academy of Chinese Medical Sciences | Recruiting | 18 Years | 75 Years | All | 60 | Early Phase 1 | China | |
| 65 | NCT03695185 | March 26, 2019 | 4 November 2019 | A Study to Investigate How Well ABBV-323 Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | A Multicenter, Single Arm, Open-label Study to Investigate the Efficacy and Safety of ABBV-323 in Subjects With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy | Ulcerative Colitis (UC) | Drug: ABBV-323 Dose B;Drug: ABBV-323 Dose A | AbbVie | Recruiting | 18 Years | 75 Years | All | 60 | Phase 2 | United States;Canada;France;Germany;Italy;Korea, Republic of;Netherlands;Spain;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | EUCTR2018-002136-24-PT | 18/03/2019 | 30 April 2019 | A clinical trial to investigate the Efficacy and Safety of TD-1473 for the Treatment of Moderately-to-Severely Active Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy with TD-1473 in Subjects with Moderately-to-Severely Active Ulcerative Colitis - Rhea: Efficacy and Safety of TD-1473 in Ulcerative Colitis | Moderately-to-Severely Active Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TD-1473 Product Code: TD-1473 Pharmaceutical Form: Coated tablet INN or Proposed INN: Not assigned Current Sponsor code: TD-1473 Other descriptive name: THRX-139060 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use Product Name: TD-1473 Product Code: TD-1473 Pharmaceutical Form: Coated tablet INN or Proposed INN: Not assigned Current Sponsor code: TD-1473 Other descriptive name: THRX-139060 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use Product Name: TD-1473 Product Code: TD-1473 Pharmaceutical Form: Coated tablet INN or Proposed INN: Not assigned Current Sponsor code: TD-1473 Other descriptive name: THRX-139060 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use | Theravance Biopharma Ireland Limited | Authorised | Female: yes Male: yes | 880 | Phase 2;Phase 3 | Serbia;Portugal;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;India;France;Hungary;Canada;Poland;Croatia;Australia;Georgia;South Africa;Bulgaria;Germany | |||
| 67 | NCT03768219 | March 18, 2019 | 22 October 2019 | Study to Evaluate APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis | Phase 1 Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of APVO210 in Healthy Subjects, Patients With Psoriasis, and Patients With Ulcerative Colitis | Psoriasis;Ulcerative Colitis | Biological: APVO210;Biological: Placebo | Aptevo Therapeutics | Not recruiting | 18 Years | 65 Years | All | 144 | Phase 1 | Australia | |
| 68 | NCT03884439 | March 18, 2019 | 4 November 2019 | Infliximab Biosimilar Pfizer Drug Use Investigation (Crohn's Disease or Ulcerative Colitis) | Infliximab BS for Intravenous Drip Infusion 100 mg Pfizer General Investigation (Crohn's Disease or Ulcerative Colitis) | Crohn's Disease;Ulcerative Colitis | Drug: Infliximab [infliximab biosimilar 3] | Pfizer | Recruiting | N/A | N/A | All | 300 | Phase 3 | Japan | |
| 69 | EUCTR2017-004576-57-HU | 11/03/2019 | 30 April 2019 | Novel budesonide capsules vs. budesonide tables in patients with ulcerative colitis refractory to standard treatment with mesalazine | Randomised, double-blind, double-dummy, active-controlled, phase III clinical trial on the efficacy and safety of an 8-week add-on treatment with budesonide 9 mg capsules vs. budesonide 6 mg capsules vs. budesonide-MMX® 9 mg tablets in patients with ulcerative colitis refractory to standard treatment with mesalazine - TOPICAL-2 | Patients with active ulcerative colitis refractory to standard treatment with mesalazine MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 9 mg capsules, hard (BUX-PVII prototype) Pharmaceutical Form: Capsule, hard INN or Proposed INN: BUDESONIDE CAS Number: 51333-22-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 9- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: Budesonide 6 mg capsules, hard (BUX-PVII prototype) Pharmaceutical Form: Capsule, hard INN or Proposed INN: BUDESONIDE CAS Number: 51333-22-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 6- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: CortimentMMX 9 mg Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: BUDESONIDE CAS Number: 51333-22-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 9- Pharmaceutical form of the placebo: Prolonged-release tablet Route of administration of the placebo: Oral use | Dr. Falk Pharma GmbH | Authorised | Female: yes Male: yes | 777 | Phase 3 | Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany | |||
| 70 | NCT03758443 | March 11, 2019 | 30 September 2019 | Efficacy & Safety of TD-1473 in Ulcerative Colitis | A Phase 2b/3 Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled, Parallel-Group Set of Studies to Evaluate the Efficacy and Safety of Induction and Maintenance Therapy With TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) | Drug: TD-1473 Dose A;Drug: TD-1473 Dose B;Drug: TD-1473 Dose C;Drug: Placebo | Theravance Biopharma | Recruiting | 18 Years | N/A | All | 880 | Phase 2/Phase 3 | United States;Bulgaria;Georgia;Greece;Hungary;Israel;Poland;Portugal;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 71 | NCT03773445 | March 1, 2019 | 25 March 2019 | Golimumab Trough Levels in Patients With Ulcerative Colitis | Association of Golimumab Trough Levels With Endoscopic and Histologic Healing in Patients With Ulcerative Colitis | Ulcerative Colitis | Diagnostic Test: Golimumab trough levels;Diagnostic Test: Antibodies to golimumab;Diagnostic Test: Histology;Diagnostic Test: Colonoscopy | Hospital San Carlos, Madrid | Hospital Universitario La Fe;Hospital Universitario 12 de Octubre;Hospital Universitario Ramon y Cajal;Gregorio Marañón Hospital;Complejo Hospitalario de Navarra;Hospital Universitario Fundación Alcorcón;Hospital Infanta Sofia;Hospital Clínico Universitario de Valencia;Puerta de Hierro University Hospital;Hospital Universitario La Paz;Hospital Universitario de Fuenlabrada;Merck Sharp & Dohme Corp. | Recruiting | 18 Years | N/A | All | 100 | Phase 3 | Spain |
| 72 | EUCTR2017-000574-11-GR | 26/02/2019 | 28 February 2019 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn’s Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn’s Disease (AIDA) - AIDA | Ulcerative colitis or Crohn’s Disease MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- | Shire Human Genetic Therapies, Inc. | Authorised | Female: yes Male: yes | 2453 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | |||
| 73 | NCT03942861 | February 21, 2019 | 20 May 2019 | Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol. | Sonographic Assessment in Severe Ulcerative Colitis Patients Admitted for Intravenous Corticosteroids and Eligible for Infliximab Rescue Therapy; a Prospective Clinician-blinded Observational Study Protocol. | Ulcerative Colitis;Ultrasound Therapy; Complications | Drug: Solu-Medrol | Copenhagen University Hospital at Herlev | Recruiting | 18 Years | 70 Years | All | 50 | Phase 3 | Denmark | |
| 74 | EUCTR2018-003349-41-HU | 19/02/2019 | 28 February 2019 | Clinical trial to evaluate the benefit and safety of ST-0529 in subjects who are suffering from active ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects with Moderately to Severely Active Ulcerative Colitis | Active ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ST-0529 Product Code: FP-CYA-050 Pharmaceutical Form: Capsule INN or Proposed INN: CICLOSPORIN CAS Number: 59865-13-3 Other descriptive name: cyclosporine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 37.5- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Product Name: ST-0529 Product Code: FP-CYA-053 Pharmaceutical Form: Capsule INN or Proposed INN: CICLOSPORIN CAS Number: 59865-13-3 Other descriptive name: cyclosporine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 18.75- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Sublimity Therapeutics (Hold Co) Ltd. | Authorised | Female: yes Male: yes | 280 | Phase 2 | Serbia;United States;Belarus;Spain;Ukraine;Ireland;Turkey;Russian Federation;Israel;United Kingdom;France;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany | |||
| 75 | ChiCTR1900021229 | 2019-02-18 | 4 February 2019 | The role of fecal calprotectin in the treatment of patients with clinically quiescent ulcerative colitis | The role of fecal calprotectin in the treatment of patients with clinically quiescent ulcerative colitis | Ulcerative colitis | Intervention group:Increasing the dose of mesalamine according to fecal calprotectin levels;Control group:Maintaining current dosage of mesalamine; | Beijing Friendship Hospital, Capital Medical University | Not Recruiting | Both | Intervention group:74;Control group:74; | Other | China | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 76 | NCT03832400 | February 4, 2019 | 25 February 2019 | Safety and Efficacy of Microbial Ecosystem Therapeutic-2 (MET-2) in Patients With Ulcerative Colitis (UC) | A Phase 1b, Placebo-controlled, Study of the Safety and Efficacy of MET-2 in Patients With Ulcerative Colitis | Ulcerative Colitis | Biological: MET-2;Drug: Placebo oral capsule | NuBiyota | Recruiting | 18 Years | N/A | All | 30 | Phase 1 | Canada | |
| 77 | NCT03824561 | February 1, 2019 | 25 February 2019 | Specified Drug-Use Survey on Vedolizumab for IV Infusion 300 mg [Ulcerative Colitis] | Specified Drug-Use Survey on Entyvio for IV Infusion 300 mg [Ulcerative Colitis] | Ulcerative Colitis | Drug: Vedolizumab | Takeda | Recruiting | N/A | N/A | All | 1000 | Phase 2 | Japan | |
| 78 | EUCTR2017-003229-14-DE | 31/01/2019 | 28 February 2019 | AN INDUCTION STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (LUCENT 1) - LUCENT 1 | Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 Pharmaceutical Form: Solution for infusion INN or Proposed INN: MIRIKIZUMAB Current Sponsor code: LY3074828 Other descriptive name: MIRIKIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Eli Lilly and Company | Authorised | Female: yes Male: yes | 1160 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan | |||
| 79 | NCT03844932 | January 24, 2019 | 11 November 2019 | A Study Evaluating the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: ST-0529 | Sublimity Therapeutics Holdco Limited | Dr. Falk Pharma GmbH | Recruiting | 18 Years | 75 Years | All | 280 | Phase 2 | United States;Belarus;Bulgaria;Canada;France;Germany;Hungary;Ireland;Italy;Poland;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom |
| 80 | NCT03804931 | January 20, 2019 | 28 January 2019 | Fecal Microbiota Transplantation for Ulcerative Colitis | Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis | Ulcerative Colitis;Fecal Microbiota Transplantation | Procedure: Fecal microbiota transplantation;Procedure: Infusion of Saline;Drug: 5-Aminosalicylic acid(5-ASA) and/or Prednisone | Guangzhou First People's Hospital | Recruiting | 18 Years | 65 Years | All | 120 | Phase 2/Phase 3 | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 81 | NCT04114292 | January 17, 2019 | 14 October 2019 | TUDCA as a Therapy for Ulcerative Colitis (UC) | A Phase I Open Label Study of the Efficacy and Safety of Tudca in Ulcerative Colitis | Ulcerative Colitis | Drug: Tauroursoursodeoxycholic acid, brand name Tudcabil | Washington University School of Medicine | Crohn's and Colitis Foundation | Recruiting | 18 Years | 65 Years | All | 12 | Phase 1 | United States |
| 82 | NCT03650413 | January 14, 2019 | 11 November 2019 | An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease | A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Patients With Moderate to Severe Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: UTTR1147A | Genentech, Inc. | Recruiting | 18 Years | 80 Years | All | 320 | Phase 2 | United States;Bulgaria;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine;United Kingdom | |
| 83 | NCT03679546 | January 4, 2019 | 11 November 2019 | EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis | EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis : A Double Blinded Randomized Clinical Trial | Ulcerative Colitis | Drug: Infliximab;Drug: Vedolizumab Injection | Rennes University Hospital | Recruiting | 18 Years | 75 Years | All | 150 | Phase 4 | France | |
| 84 | EUCTR2018-002925-47-ES | 28/12/2018 | 28 February 2019 | prediction of response to therapy in inflammatory bowel disease | Identification of predictive biomarkers for response to biologic therapies in inflammatory bowel disease by proteomic and mass cytometry approaches | Inflammatory bowel disease MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Adalimumab Pharmaceutical Form: Injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Trade Name: Infliximab Pharmaceutical Form: Infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 5- Trade Name: Golimumab Pharmaceutical Form: Injection INN or Proposed INN: GOLIMUMAB CAS Number: 476181-74-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: Ustekinumab Pharmaceutical Form: Injection INN or Proposed INN: USTEKINUMAB CAS Number: 815610-63-0 Other descriptive name: USTEKINUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 90- Trade Name: Vedolizumab Pharmaceutical Form: Infusion INN or Proposed INN: VEDOLIZUMAB CAS Number: 943609-66-3 Other descriptive name: VEDOLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- | Fundación de Investigación Biomédica del Hospital Universitario de La Princesa | Authorised | Female: yes Male: yes | 180 | Phase 4 | Spain | |||
| 85 | NCT03765450 | December 21, 2018 | 15 July 2019 | Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis | Pharmacokinetics of Infliximab and Tumor Necrosis Factor Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis | Ulcerative Colitis | Drug: Infliximab | Robarts Clinical Trials Inc. | Recruiting | 18 Years | N/A | All | 30 | Phase 3 | United States;Canada | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 86 | NCT03759041 | December 19, 2018 | 28 October 2019 | A Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis | ECO-RESET: A Phase 2B, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Multicenter Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: Vancomycin Pre-Treatment;Drug: Placebo for Vancomycin Pre-Treatment;Drug: SER-287;Drug: Placebo for SER-287 | Seres Therapeutics, Inc. | Recruiting | 18 Years | 80 Years | All | 201 | Phase 2 | United States;Canada | |
| 87 | EUCTR2016-000642-62-LV | 13/12/2018 | 28 February 2019 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in subjects with Moderately to Severely Active Ulcerative Colitis | M14-675, A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 Pharmaceutical Form: Tablet INN or Proposed INN: Upadacitinib CAS Number: 1310726-60-3 Current Sponsor code: ABT-494 Other descriptive name: ABT-494 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 45- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | AbbVie Deutschland GmbH & Co. KG | Authorised | Female: yes Male: yes | 462 | Phase 3 | Portugal;Serbia;Belarus;United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Colombia;Switzerland;France;Puerto Rico;Malaysia;Australia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Germany;Norway;Japan | |||
| 88 | NCT03574948 | December 6, 2018 | 11 June 2019 | 5-HTP in Patients With IBD in Clinical and Biologic Remission:Effect on Fatigue Scores | Multicentric, Double-blind, Placebo Controlled Clinical Trial With 5-hydroxytryptophan (5-HTP) in Patients With Inflammatory Bowel Disease in Clinical and Biologic Remission: Effect on Fatigue Scores | Crohn Disease;Ulcerative Colitis;Fatigue;Remission | Drug: 5-HTP;Drug: Placebo oral capsule | University Hospital, Ghent | Recruiting | 18 Years | 60 Years | All | 180 | Phase 2 | Belgium | |
| 89 | JPRN-UMIN000034016 | 2018/12/01 | 7 October 2019 | The investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled study | The investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled study - STABILITY study | ulcerative colitis | Additional remission maintenance therapy by mesalazine enema with continuation of concomitant treatment at the remission induction by budesonide form enema The continuation of concomitant treatment at the remission induction by budesonide form enema (control group) | Hyogo College of Medicine | Recruiting | 16years-old | Not applicable | Male and Female | 84 | Not selected | Japan | |
| 90 | NCT03716388 | December 1, 2018 | 25 February 2019 | Fecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UC | Fecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UC : a Pilot Study | Ulcerative Colitis Chronic Mild;Ulcerative Colitis Chronic Moderate | Biological: Fecal Microbiota Transplantation;Drug: Mesalamine Granules;Other: Placebo infusion;Other: Placebo granules | Dayanand Medical College and Hospital | Colitis & Crohn's Foundation (India) | Recruiting | 18 Years | 75 Years | All | 20 | Phase 3 | India |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 91 | NCT03944447 | December 1, 2018 | 7 October 2019 | Outcomes Mandate National Integration With Cannabis as Medicine | Outcomes Mandate National Integration With Cannabis as Medicine | Chronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar Disorder | Drug: Cannabis, Medical | OMNI Medical Services, LLC | Recruiting | 7 Years | N/A | All | 100000 | Phase 2 | United States | |
| 92 | NCT02201758 | December 2018 | 25 June 2018 | Flaxseed Lignan-Enriched Complex (FLC) for the Treatment of Patients With Ulcerative Colitis (UC): A Pilot Assessment | Flaxseed Lignan-enriched Complex (FLC) for the Treatment of Patients With Mild to Moderately Severe Ulcerative Colitis (UC): A Pilot Assessment. | Ulcerative Colitis | Dietary Supplement: Flaxseed lignan-enriched complex (FLC);Other: Placebo | University of Saskatchewan | Royal University Hospital Foundation | Not recruiting | 18 Years | N/A | All | 56 | Phase 2 | Canada |
| 93 | NCT03729674 | November 26, 2018 | 3 December 2018 | Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs | Comparative Effectiveness and Safety of Biosimilar and Legacy Drugs | Rheumatoid Arthritis;Ankylosing Spondylitis;Ulcerative Colitis;Crohn's Disease | Drug: Biosimilar;Drug: Originator (legacy) drug | McGill University Health Center | Université de Sherbrooke;Institut de rhumatologie de Montréal;Hospital for Special Surgery, New York;University of Manitoba;University of Toronto;University of Alberta;University of British Columbia;Alberta Health Services;McMaster University;The Arthritis Program Research Group | Not recruiting | 18 Years | N/A | All | 800 | Phase 3 | |
| 94 | NCT03662542 | November 20, 2018 | 11 November 2019 | A Study of Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2a Randomized, Double-blind, Active-controlled, Parallel-group, Multicenter, Proof-of-concept Clinical Study to Evaluate the Efficacy and Safety of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Guselkumab Dose 1;Drug: Guselkumab Dose 2;Drug: Golimumab Dose 1;Drug: Golimumab Dose 2;Drug: Placebo | Janssen Research & Development, LLC | Recruiting | 18 Years | 65 Years | All | 210 | Phase 2 | United States;Argentina;Australia;Brazil;Germany;Mexico;Poland;Russian Federation;Ukraine | |
| 95 | EUCTR2016-004676-22-DK | 15/11/2018 | 28 February 2019 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Risankizumab Product Code: ABBV-006 Pharmaceutical Form: Solution for infusion INN or Proposed INN: RISANKIZUMAB Current Sponsor code: ABBV-066 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Product Name: Risankizumab Product Code: ABBV-066 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: RISANKIZUMAB Current Sponsor code: ABBV-066 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 90- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use | AbbVie Deutschland GmbH & Co. KG | Authorised | Female: yes Male: yes | 760 | Phase 3 | Serbia;Portugal;United States;Belarus;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;Switzerland;France;Malaysia;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan;Sweden | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 96 | NCT03596645 | October 29, 2018 | 11 November 2019 | A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Golimumab Treatment, a Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Golimumab;Drug: Infliximab | Janssen Research & Development, LLC | Recruiting | 2 Years | 17 Years | All | 125 | Phase 3 | United States;Belgium;Brazil;France;Israel;Italy;Korea, Republic of;Netherlands;Poland;Spain;Taiwan | |
| 97 | NCT03648541 | October 29, 2018 | 4 November 2019 | BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis | An Open Label, Long Term Safety Trial of BI 655130 Treatment in Patients With Moderate to Severely Active Ulcerative Colitis Who Have Completed Previous BI 655130 Trials | Colitis, Ulcerative | Drug: Spesolimab IV infusion;Drug: Spesolimab SC solution for injection | Boehringer Ingelheim | Recruiting | 18 Years | N/A | All | 535 | Phase 2 | United States;Austria;Belgium;Canada;Germany;Italy;Japan;Korea, Republic of;Russian Federation;Spain;United Kingdom | |
| 98 | NCT03558152 | October 26, 2018 | 11 November 2019 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and With Vedolizumab in Participants With Moderate to Severe Ulcerative Colitis (UC) | A Phase II, Randomized, Parallel-Group, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared With Placebo and Compared With Vedolizumab in Patients With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: UTTR1147A;Drug: UTTR1147A Placebo;Drug: Vedolizumab;Drug: Vedolizumab Placebo | Genentech, Inc. | Recruiting | 18 Years | 80 Years | All | 270 | Phase 2 | United States;Bulgaria;China;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Netherlands;Poland;Russian Federation;Serbia;Spain;Ukraine;United Kingdom | |
| 99 | EUCTR2018-000334-35-BE | 22/10/2018 | 7 January 2019 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 Pharmaceutical Form: Solution for infusion INN or Proposed INN: BI 655130 Current Sponsor code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Product Code: BI 655130 Pharmaceutical Form: Solution for injection INN or Proposed INN: BI 655130 Current Sponsor code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- | SCS Boehringer Ingelheim Comm V. | Authorised | Female: yes Male: yes | 160 | Phase 2 | United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Canada;Belgium;Poland;Germany;Netherlands;Japan;Korea, Republic of | |||
| 100 | NCT03524092 | October 19, 2018 | 11 November 2019 | A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 2) | Ulcerative Colitis | Drug: Mirikizumab;Drug: Placebo | Eli Lilly and Company | Recruiting | 18 Years | 80 Years | All | 1044 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Poland;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 101 | EUCTR2017-003238-96-DE | 15/10/2018 | 28 February 2019 | A MAINTENANCE STUDY OF THE EFFICACY AND SAFETY OF MIRIKIZUMAB IN ULCERATIVE COLITIS | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-ARM, PLACEBO-CONTROLLED MAINTENANCE STUDY OF MIRIKIZUMAB IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS (LUCENT 2) - LUCENT 2 | Moderately to Severely Active Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: mirikizumab Product Code: LY3074828 Pharmaceutical Form: Solution for injection INN or Proposed INN: MIRIKIZUMAB Current Sponsor code: LY3074828 Other descriptive name: MIRIKIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Name: mirikizumab Product Code: LY3074828 Pharmaceutical Form: Solution for infusion INN or Proposed INN: MIRIKIZUMAB Current Sponsor code: LY3074828 Other descriptive name: MIRIKIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- | Eli Lilly and Company | Authorised | Female: yes Male: yes | 1044 | Phase 3 | Serbia;United States;Saudi Arabia;Taiwan;Slovakia;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Malaysia;Australia;Denmark;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Germany;Japan | |||
| 102 | NCT02921555 | October 11, 2018 | 22 July 2019 | Endovenous Corticosteroid Pulses in Moderate Ulcerative Colitis | Efficacy of High-dose Corticosteroid Pulses Added to Conventional Oral Corticosteroid Course for Moderate Flares of Ulcerative Colitis. | Ulcerative Colitis | Drug: Methylprednisolone;Drug: Prednisone | Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa | Recruiting | 18 Years | N/A | All | 148 | Phase 4 | Spain | |
| 103 | NCT03653026 | October 4, 2018 | 11 November 2019 | A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) | Drug: Upadacitinib (ABT-494);Drug: Placebo | AbbVie | Recruiting | 16 Years | 75 Years | All | 462 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;Egypt;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Belarus;Sweden | |
| 104 | NCT03669029 | October 1, 2018 | 24 September 2018 | Optimization of Golimumab Treatment in Ulcerative Colitis | Optimization of Golimumab Treatment in Ulcerative Colitis | Colitis, Ulcerative | Drug: Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg;Drug: Golimumab treatment optimization. | Hospital de Manises | Valencia University General Hospital;Hospital Clínico Universitario de Valencia;Hospital de Sagunt;Hospital Universitario La Fe;Hospital General Universitario de Alicante;Hospital Universitario Doctor Peset;Hospital Arnau de Vilanova;Hospital Provincial de Castellon;Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | 80 Years | All | 50 | Phase 4 | Spain |
| 105 | NCT03627052 | September 20, 2018 | 7 October 2019 | A Study to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis | A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis | Moderate to Severe Ulcerative Colitis | Drug: Itacitinib;Drug: Placebo | Incyte Corporation | Recruiting | 18 Years | 74 Years | All | 206 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 106 | EUCTR2018-000334-35-ES | 17/09/2018 | 10 October 2018 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 Pharmaceutical Form: Solution for infusion INN or Proposed INN: BI 655130 Current Sponsor code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Product Code: BI 655130 Pharmaceutical Form: Solution for injection INN or Proposed INN: BI 655130 Current Sponsor code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- | Boehringer Ingelheim España, S.A. | Authorised | Female: yes Male: yes | 160 | Phase 2 | United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Canada;Belgium;Poland;Germany;Netherlands;Japan;Korea, Republic of | |||
| 107 | JPRN-JapicCTI-184131 | 10/9/2018 | 16 July 2019 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Intervention name : ABT-494 INN of the intervention : upadacitinib Dosage And administration of the intervention : Will be orally administered Control intervention name : Placebo Dosage And administration of the control intervention : Will be orally administered | AbbVie GK | Recruiting | 18 | 75 | BOTH | Phase 3 | |||
| 108 | EUCTR2018-001051-12-FR | 07/09/2018 | 24 September 2018 | VEDO - PREDIRESPUC project - Vedolizumab and anti-vedolizumab antibody in the prediction of therapeutic response in Ulcerative Colitis | VEDO - PREDIRESPUC project - Value of pharmacokinetic assays (Vedolizumab and anti-vedolizumab antibody) in the prediction of induction and maintenance therapeutic response in Ulcerative Colitis | Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: ENTYVIO Product Name: ENTYVIO Product Code: 1 Pharmaceutical Form: Powder for concentrate and solution for solution for infusion | CHU Saint-Etienne | Authorised | Female: yes Male: yes | 125 | Phase 4 | France | |||
| 109 | EUCTR2018-002673-21-FR | 04/09/2018 | 10 October 2018 | EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial. | EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial. - EFFICACI | Ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: Remicade Product Name: infliximab Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 5- Trade Name: Inflectra Product Name: infliximab Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 5- Trade Name: Flixabi Product Name: infliximab Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 5- Trade Name: Remsima Product Name: infliximab Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 5- Trade Name: Entyvio Product Name: Vedolizumab Pharmaceutical Form: Powder for solution for infusion CAS Number: 943609-66-3 Other descriptive name: VEDOLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- | Centre Hospitalier Universitaire de Rennes | Authorised | Female: yes Male: yes | 150 | Phase 4 | France | |||
| 110 | EUCTR2017-002350-36-NL | 28/08/2018 | 1 October 2018 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis. | A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis (UC) MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10033007 Term: Other ulcerative colitis System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10045366 Term: Ulcerative colitis, unspecified System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 MedDRA version: 20.0 Level: LLT Classification code 10075635 Term: Acute hemorrhagic ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: UTTR1147A/RO7021610 (Active) Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: n.a. Current Sponsor code: RO7021610 Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Trade Name: Entyvio 300mg Product Code: RO7246311 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Vedolizumab CAS Number: 943609-66-3 Current Sponsor code: RO7246311 Other descriptive name: VEDOLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Genentech, Inc. | Authorised | Female: yes Male: yes | 330 | Phase 2 | Bulgaria;Netherlands;Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Germany | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 111 | NCT03398135 | August 28, 2018 | 4 November 2019 | A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065 | Ulcerative Colitis (UC) | Drug: risankizumab;Drug: placebo for risankizumab | AbbVie | Recruiting | 16 Years | 80 Years | All | 760 | Phase 3 | United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Denmark;Egypt;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;American Samoa;Australia;Czechia | |
| 112 | EUCTR2018-000334-35-AT | 20/08/2018 | 3 September 2018 | BI 655130 long-term treatment in patients with moderate-to-severe ulcerative colitis | An open label, long term safety trial of BI 655130 treatment in patients with moderate to severely active ulcerative colitis who have completed previous BI 655130 trials | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 Pharmaceutical Form: Solution for infusion INN or Proposed INN: BI 655130 Current Sponsor code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Product Code: BI 655130 Pharmaceutical Form: Solution for injection INN or Proposed INN: BI 655130 Current Sponsor code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- | Boehringer Ingelheim RCV GmbH&Co. KG | Authorised | Female: yes Male: yes | 160 | Phase 2 | United States;Spain;Austria;Russian Federation;United Kingdom;Italy;Canada;Belgium;Poland;Germany;Netherlands;Japan;Korea, Republic of | |||
| 113 | NCT03546868 | August 14, 2018 | 3 September 2018 | Diagnostic Validity of [18F]FSPG PET for the Assessment of Disease Activity in Inflammatory Bowel Disease | Phase 2, Open-label, Non-randomized, Single Center Study to Explore Diagnostic Validity of [18F]FSPG PET for the Assessment of Disease Activity in Subjects With Inflammatory Bowel Disease. | Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn Disease | Drug: [18F]FSPG | Asan Foundation | Recruiting | 19 Years | 79 Years | All | 20 | Phase 2 | Korea, Republic of | |
| 114 | NCT03616821 | August 7, 2018 | 9 September 2019 | An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis [EXPEDITION] | A 54-Week Treatment, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled, Parallel-Group Phase 2 Study to Assess the Efficacy and Safety of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis | Colitis;Ulcerative;IBD | Drug: Brazikumab;Drug: Vedolizumab;Drug: Placebo | Allergan | Recruiting | 18 Years | 80 Years | All | 375 | Phase 2 | United States;Canada | |
| 115 | NCT03196427 | July 30, 2018 | 15 July 2019 | Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD) | A Phase 2b, Extension Study to Determine the Long-term Safety of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Vedolizumab | Takeda | Recruiting | 2 Years | 17 Years | All | 80 | Phase 2 | United States;Belgium;Canada;France;Hungary;Israel;Netherlands;Poland;Ukraine;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 116 | NCT03519945 | July 18, 2018 | 11 November 2019 | A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3) | A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis LUCENT 3 | Ulcerative Colitis | Drug: Mirikizumab | Eli Lilly and Company | Recruiting | 18 Years | 80 Years | All | 840 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Croatia;Czechia;Denmark;France;Georgia;Germany;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Moldova, Republic of;Netherlands;Poland;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom | |
| 117 | NCT03860571 | July 6, 2018 | 11 March 2019 | Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers | A Randomized, Placebo-Controlled, Sequential Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral BT-11 in Healthy Adult Male and Female Volunteers | Ulcerative Colitis;Crohn Disease | Drug: BT-11 Placebo;Drug: BT-11 Active | Landos Biopharma Inc. | Not recruiting | 18 Years | 65 Years | All | 70 | Phase 1 | United States | |
| 118 | NCT02469220 | July 1, 2018 | 20 May 2019 | Diet Treatment of Patients With Ulcerative Colitis in Remission | Diet Treatment of Patients With Ulcerative Colitis in Remission | Ulcerative Colitis | Dietary Supplement: Low FODMAP;Dietary Supplement: Standardized FODMAP | Vendsyssel Hospital | Recruiting | 18 Years | 70 Years | All | 45 | N/A | Denmark | |
| 119 | NCT03609905 | July 1, 2018 | 20 August 2018 | Adipose Mesenchymal Stem Cells (AMSC) for Treatment of Ulcerative Colitis | A Phase I/II Randomized, Controlled, Clinical Trial for Assessment of the Safety and Efficacy of Allogeneic Adipose Mesenchymal Stem Cells in Moderate to Severe Ulcerative Colitis Patients | Ulcerative Colitis (UC) | Biological: Adipose-cord mesenchymal stromal cells (A-MSCs);Other: Conventional drugs | Liaocheng People's Hospital | Recruiting | 18 Years | 65 Years | All | 50 | Phase 1/Phase 2 | China | |
| 120 | NCT03773952 | July 1, 2018 | 18 December 2018 | Safety and Efficacy of PBF-677 in Ulcerative Colitis Patients | A Phase IIa (Proof of Concept), Randomized, Double Blind, Placebo Controlled, Multicenter Clinical Trial to Evaluate the Safety and Efficacy of Oral Treatment With PBF-677 in Patients With Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: PBF-677;Drug: Placebo oral capsule | Palobiofarma SL | Qualitecfarma | Recruiting | 18 Years | 75 Years | All | 50 | Phase 2 | Spain |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 121 | ChiCTR1800016438 | 2018-06-30 | 5 June 2018 | Clinical research of flupentixol-melitracen and mesalazine on ulcerative colitis | Clinical research of flupentixol-melitracen and mesalazine on ulcerative colitis | ulcerative colitis | control:mesalazine 1 po qid;observation group:mesalazine 1 po qid; flupentixol-melitracen 1pill po tid; | Guiyang 1st People's Hospital | Not Recruiting | 15 | 75 | Both | control:30;observation group:30; | Pilot study | China | |
| 122 | EUCTR2017-004967-11-FR | 26/06/2018 | 10 October 2018 | Prospective multicenter randomized controlled double-blind label study of the prophylaxis of recurrent pouchitis after fecal microbiota transplant in UC with ileo-anal anastomosis. | Poca - Poca | Patients operated with an IPAA for Ulcerative Colitis with active recurrent pouchitis, who respond after 4 weeks of an antibiotherapy, will be randomized MedDRA version: 20.1 Level: LLT Classification code 10000638 Term: Active ileal inflammation System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: suspension de microbiote fécal Product Code: PRD5973697 Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Rectal use | CHU Nantes | Authorised | Female: yes Male: yes | 42 | Phase 3 | France | |||
| 123 | NCT03518086 | June 18, 2018 | 11 November 2019 | An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1) | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1) | Ulcerative Colitis | Drug: Mirikizumab;Drug: Placebo | Eli Lilly and Company | Recruiting | 18 Years | 80 Years | All | 1160 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;China;Croatia;Czechia;Denmark;France;Germany;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Poland;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;Brazil | |
| 124 | EUCTR2017-002350-36-HU | 14/06/2018 | 20 August 2018 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis. | A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis (UC) MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10033007 Term: Other ulcerative colitis System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10045366 Term: Ulcerative colitis, unspecified System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 MedDRA version: 20.0 Level: LLT Classification code 10075635 Term: Acute hemorrhagic ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: n.a. Product Code: UTTR1147A/RO7021610 (Active) Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: n.a. Current Sponsor code: RO7021610 Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Trade Name: Entyvio 300mg Product Code: RO7246311 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Vedolizumab CAS Number: 943609-66-3 Current Sponsor code: RO7246311 Other descriptive name: VEDOLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Genentech, Inc. | Authorised | Female: yes Male: yes | 270 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands | |||
| 125 | NCT03531892 | June 6, 2018 | 22 July 2019 | A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis | Phase III Study of AJM300 in Patients With Active Ulcerative Colitis | Colitis, Ulcerative | Drug: AJM300;Drug: Placebo | EA Pharma Co., Ltd. | Kissei Pharmaceutical Co., Ltd. | Recruiting | 16 Years | 74 Years | All | 198 | Phase 3 | Japan |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 126 | EUCTR2017-003284-35-ES | 05/06/2018 | 18 June 2018 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily in patients with moderate to severe Active Ulcerative Colitis. | A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis - A follow-up study in patients with moderate to severe active ulcerative colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 Pharmaceutical Form: Capsule, hard INN or Proposed INN: ABX464 Current Sponsor code: ABX464 Other descriptive name: ABX464 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | ABIVAX | Authorised | Female: yes Male: yes | 30 | Phase 2 | Hungary;Spain | |||
| 127 | EUCTR2017-004230-28-DE | 04/06/2018 | 7 January 2019 | BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: BI 655130 Product Code: BI 655130 Pharmaceutical Form: Solution for infusion INN or Proposed INN: BI 655130 Current Sponsor code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Boehringer Ingelheim Pharma GmbH & Co. KG | Authorised | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Spain;Austria;Russian Federation;United Kingdom;Italy;Canada;Belgium;Poland;Germany;Netherlands;Japan;Korea, Republic of | |||
| 128 | NCT03477032 | June 1, 2018 | 11 June 2019 | FMT in Inflammatory Bowel Disease | Faecal Transplantation in Inflammatory Bowel Disease | Faecal Microbiota Transplantation;Crohn Disease;Ulcerative Colitis;Microscopic Colitis | Biological: Faecal Microbiota Transplantation | St Vincent's Hospital Melbourne | Recruiting | 18 Years | 65 Years | All | 50 | Phase 2 | Australia | |
| 129 | NCT03504930 | June 2018 | 11 June 2018 | COLISURG Prospective, Multicentric Cohort | COLISURG Prospective, Multicentric Cohort of Ulcerative Colitis Requiring Surgical Treatment With Ileal Pouch-anal Anastomosis. Impact of Biotherapies on Sexual Function and Postoperative Morbidity. | Ulcerative Colitis | Other: Impact of biotherapy on postoperative morbidity in ulcerative colitis | Hospices Civils de Lyon | Not recruiting | 18 Years | N/A | All | 330 | Phase 3 | France | |
| 130 | JPRN-JapicCTI-183997 | 29/5/2018 | 7 October 2019 | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy [M16-067] | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy [M16-067] | Ulcerative Colitis (UC) | Intervention name : Risankizumab (Genetical Recombination) INN of the intervention : risankizumab Dosage And administration of the intervention : SC/IV Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | AbbVie GK | Recruiting | 16 | 80 | BOTH | 65 | Phase 2-3 | Japan, Asia except Japan, North America, South America, Europe, Oceania, Africa | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 131 | EUCTR2017-003228-54-ES | 28/05/2018 | 18 June 2018 | A clinical trial to evaluate the safety and efficacy of oral treatment with PBF-677 in patients with mild to moderate ulcerative colitis. | A Phase IIa (proof of concept), randomized, double blind, placebo controlled, multicenter clinical trial to evaluate the safety and efficacy of oral treatment with PBF-677 in patients with mild to moderate ulcerative colitis. | Inflammatory Bowel disease, mild to moderate Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PBF-677 Pharmaceutical Form: Capsule, hard INN or Proposed INN: PBF-677 Current Sponsor code: PBF-677 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | PaloBiofarma S.L. | Authorised | Female: yes Male: yes | 30 | Phase 2 | Spain | |||
| 132 | NCT03521232 | May 15, 2018 | 26 August 2019 | A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Proctosigmoiditis | A Phase I/IIA, Open-Label, Three-Stage Study to Investigate the Safety, the Efficacy and the Pharmacokinetics of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Procto-Sigmoiditis | Ulcerative Colitis;Ulcerative Proctitis;Ulcerative Proctosigmoiditis | Drug: Niclosamide | First Wave Bio, Inc. | Recruiting | 18 Years | N/A | All | 51 | Phase 1/Phase 2 | Italy | |
| 133 | NCT03565939 | May 4, 2018 | 30 September 2019 | Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO) | Probiotic Treatment of Ulcerative Colitis With Trichuris Suis Ova (TSO) | Ulcerative Colitis Chronic Moderate | Biological: Trichuris suis ova;Biological: Placebo | ParaTech A/S | Recruiting | 18 Years | 75 Years | All | 120 | Phase 2 | Denmark | |
| 134 | EUCTR2017-003649-10-DE | 30/04/2018 | 28 February 2019 | A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease | A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE | Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: 549-0261/F02-01 Pharmaceutical Form: Solution for injection INN or Proposed INN: ETROLIZUMAB CAS Number: 1044758-60-2 Current Sponsor code: RO5490261/F02-01 Other descriptive name: ETROLIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- | F. Hoffmann-La Roche Ltd | Not Recruiting | Female: yes Male: yes | 60 | Phase 1 | United States;Poland;Belgium;Spain;Germany;United Kingdom | |||
| 135 | NCT03594708 | April 30, 2018 | 23 July 2018 | Immunonutrition in Ulcerative Colitis | Impact of Immunonutrition Supplementation Combining Fermentable Fiber, Omega-3 Fatty Acids, Vitamin D, Vitamin E, and Zinc on Intestinal Inflammation, Gut Microbial Activity, and Severity of Symptoms in Ulcerative Colitis Patients | Ulcerative Colitis | Dietary Supplement: Nutrition supplement;Dietary Supplement: Placebo supplement | Baptist Memorial Health Care Corporation | Recruiting | 18 Years | N/A | All | 30 | N/A | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 136 | EUCTR2017-003703-22-ES | 29/04/2018 | 14 May 2018 | Phase 2 Dose-finding IMU-838 for Ulcerative Colitis (CALDOSE-1) | A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe ulcerative colitis CALDOSE-1 | Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: vidofludimus calcium Product Code: IMU-838 Pharmaceutical Form: Tablet INN or Proposed INN: Vidofludimus calcium Current Sponsor code: IMU-838 Other descriptive name: IM90838 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: vidofludimus calcium Product Code: IMU-838 Pharmaceutical Form: Tablet INN or Proposed INN: Vidofludimus calcium Current Sponsor code: IMU-838 Other descriptive name: IM90838 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: vidofludimus calcium Product Code: IMU-838 Pharmaceutical Form: Tablet INN or Proposed INN: Vidofludimus calcium Current Sponsor code: IMU-838 Other descriptive name: IM90838 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 22.5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Immunic AG | Authorised | Female: yes Male: yes | 210 | Phase 2 | Serbia;United States;Czech Republic;Slovakia;Poland;Belgium;Spain;Ukraine;Russian Federation;Netherlands;Germany;United Kingdom | |||
| 137 | NCT03209232 | April 16, 2018 | 30 September 2019 | Infliximab Accelerated Induction in Moderate to Severe Pediatric UC | Infliximab Accelerated Induction for Moderate to Severe Ulcerative Colitis in Children (INDUCE) Trial | Ulcerative Colitis | Drug: Infliximab | Schneider Children's Medical Center, Israel | Recruiting | 6 Years | 18 Years | All | 84 | N/A | Israel | |
| 138 | EUCTR2017-002350-36-ES | 15/04/2018 | 11 June 2018 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of UTTR1147A Compared with Placebo and Compared with Vedolizumab in Patients with Moderate to Severe Ulcerative Colitis. | A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis (UC) MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10033007 Term: Other ulcerative colitis System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10045366 Term: Ulcerative colitis, unspecified System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 MedDRA version: 20.0 Level: LLT Classification code 10075635 Term: Acute hemorrhagic ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: UTTR1147A/RO7021610 (Active) Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: n.a. Current Sponsor code: RO7021610 Other descriptive name: UTTR1147A, IL22-Fc, IL-22Fc Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Trade Name: Entyvio 300mg Product Code: RO7246311 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Vedolizumab CAS Number: 943609-66-3 Current Sponsor code: RO7246311 Other descriptive name: VEDOLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Roche Farma, S.A por delegación de Genentech, Inc. | Authorised | Female: yes Male: yes | 330 | Phase 2 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;United Kingdom;Italy;Hungary;Poland;Bulgaria;Germany;Netherlands | |||
| 139 | EUCTR2017-000574-11-DE | 10/04/2018 | 7 January 2019 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- | Shire Human Genetic Therapies, Inc. | Authorised | Female: yes Male: yes | 2453 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | |||
| 140 | NCT03298022 | April 10, 2018 | 9 September 2019 | Efficacy and Safety of AbGn-168H in Patients With Moderate to Severe Active, Anti-TNF Alpha and/or Anti-integrin Refractory Ulcerative Colitis | Efficacy and Safety of AbGn-168H in Patients With Moderate to Severe Active, Anti-TNF Alpha and/or Anti-integrin Refractory Ulcerative Colitis: a 26-week, Open-label, Multi-center, Phase II Proof of Principle Trial | Ulcerative Colitis | Biological: AbGn-168H | AbGenomics International, Inc. | Recruiting | 18 Years | 75 Years | All | 40 | Phase 2 | United States;Puerto Rico | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 141 | EUCTR2017-003284-35-PL | 06/04/2018 | 22 October 2018 | A follow-up study in patients with moderate to severe active ulcerative colitis. | A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis. - Follow-up study in Moderate to Severe Active Ulcerative Colitis subjects. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 Pharmaceutical Form: Capsule, hard INN or Proposed INN: ABX464 Current Sponsor code: ABX464 Other descriptive name: ABX464 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | ABIVAX | Authorised | Female: yes Male: yes | 30 | Phase 2 | Hungary;Spain;Belgium;Poland | |||
| 142 | JPRN-jRCTs041190010 | 06/04/2018 | 10 September 2019 | The usefulness of kestose for ulcerative colitis | The usefulness of kestose for ulcerative colitis | Inflammatory Bowel Disease | arm A Kestose(10g) every day 8 weeksar arm B Maltose(5g) every day 8 weeks | Takashi Honda | Recruiting | >= 20age old | <= 80age old | Both | 40 | N/A | none | |
| 143 | EUCTR2016-004112-35-SE | 04/04/2018 | 30 April 2018 | A comparison between standard treatment with azathioprine and a modified treatment with a lower dose of azathioprine in combination with allopurinol for patients with inflammatory bowel disease | Low-dose azathioprine and allopurinol- versus azathioprine monotherapy in patients with Inflammatory Bowel Disease: An investigator-initiated, open, multicentre, parallel-arm, randomized controlled trial A SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases) study | Patients with inflammatory bowel diseae (Ulcerative colitis or Crohns disease) wh do not responding to first line therapy;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Imurel Product Name: Azathioprine Product Code: NA Pharmaceutical Form: Tablet Trade Name: Allopurinol Product Name: Allopurinol Product Code: NA Pharmaceutical Form: Tablet | SOIBD (The Swedish Organisation for the study of Inflammatory Bowel Diseases) | Authorised | Female: yes Male: yes | 120 | Phase 4 | Sweden | |||
| 144 | NCT03452501 | April 2018 | 11 June 2018 | Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients | An Observational, Prospective Cohort Study to Evaluate the Safety and Effectiveness of Remsima® in the Treatment of Inflammatory Bowel Disease Among Saudi Arabia Patients Diagnosed With Crohn's Disease, Ulcerative Colitis, or Fistulizing CD | Inflammatory Bowel Diseases Including Crohn's Disease, Fistulizing Crohn's Disease and Ulcerative Colitis | Drug: Infliximab | Hikma Pharmaceuticals LLC | Not recruiting | 18 Years | N/A | All | 150 | Phase 3 | Saudi Arabia | |
| 145 | EUCTR2017-003524-75-NL | 27/03/2018 | 30 April 2018 | Mesenchymal Stromal Cells for the treatment of Ulcerative Colitis | Allogeneic Bone Marrow Derived Mesenchymal Stromal Cells for the Treatment of Refractory Proctitis in Ulcerative Colitis - BMMSCproctitis | Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Mesenchymal stromal cells Product Code: MSC Pharmaceutical Form: Suspension for injection in pre-filled syringe INN or Proposed INN: n.a. CAS Number: n.a. Current Sponsor code: Freshly harvested_BMMSC_P3 Other descriptive name: MESENCHYMAL CELLS Concentration unit: Other Concentration type: equal Concentration number: 10000000 - | Leiden University Medical Center | Authorised | Female: yes Male: yes | 14 | Phase 2 | Netherlands | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 146 | NCT03478956 | March 27, 2018 | 28 October 2019 | A Phase I Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's Disease | A Phase I, Open-Label, Randomized, Pharmacokinetic, Pharmacodynamic, And Safety Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients From 4 Years To Less Than 18 Years Of Age With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Etrolizumab | Hoffmann-La Roche | Not recruiting | 4 Years | 17 Years | All | 24 | Phase 1 | United States;Belgium;Germany;Poland;Spain;United Kingdom | |
| 147 | NCT03581149 | March 26, 2018 | 30 September 2019 | Tolerability and Efficacy of Sodium Picosulfate/Magnesium Citrate Versus PEG/Ascorbic Acid in Ulcerative Colitis Patients | Tolerability and Efficacy of Low-Volume Sodium Picosulfate/Magnesium Citrate Versus 2L Polyethylene Glycol/Ascorbic Acid in Patients With Ulcerative Colitis Undergoing Colonoscopy: A Randomized Controlled Trial | Ulcerative Colitis | Drug: Sodium Picosulfate/Magnesium Citrate Laxative;Drug: 2L polyethylene glycol/ascorbic acid | American University of Beirut Medical Center | Recruiting | 18 Years | 65 Years | All | 68 | Phase 4 | Lebanon | |
| 148 | NCT03482648 | March 20, 2018 | 11 June 2018 | First-In-Human Study of BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Volunteers | A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Novel Oral Peptide BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Adult Subjects | Ulcerative Colitis | Drug: BBT-401-1S, Single dose;Drug: BBT-401-1S, Multiple doses;Drug: Placebo | Bridge Biotherapeutics, Inc. | KCRN Research, LLC | Recruiting | 19 Years | 55 Years | All | 80 | Phase 1 | United States |
| 149 | NCT03597971 | March 20, 2018 | 20 August 2018 | HMPL004-6599 Phase I Dose-escalating Study | A Phase I, Randomized, Double Blind, Placebo-controlled, Dose-escalating Study of the Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of HMPL004-6599 in Healthy Male Volunteers | Ulcerative Colitis;Crohn Disease | Drug: HMPL004-6599;Drug: Placebo | Nutrition Science Partners Limited | Hutchison Medipharma Limited;Nestlé | Recruiting | 18 Years | 45 Years | Male | 56 | Phase 1 | Australia |
| 150 | NCT03341962 | March 15, 2018 | 25 March 2019 | Phase 2 Dose-finding IMU-838 for Ulcerative Colitis | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of IMU-838 for Induction and Maintenance Therapy in Moderate-to-severe Ulcerative Colitis | Ulcerative Colitis | Drug: IMU-838;Drug: Placebo | Immunic AG | Recruiting | 18 Years | 80 Years | All | 150 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 151 | EUCTR2017-000574-11-IE | 13/03/2018 | 23 July 2018 | Research study to determine whether an investigational drug, SHP647, is safe and effective long term in the treatment of moderate to severe Ulcerative Colitis or Crohn's Disease (AIDA) | A Phase 3 Long-term Safety Extension Study of SHP647 in Subjects with Moderate to Severe Ulcerative Colitis or Crohn's Disease (AIDA) - AIDA | Ulcerative colitis or Crohn's Disease MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- | Shire Human Genetic Therapies, Inc. | Authorised | Female: yes Male: yes | 2453 | Phase 3 | Serbia;Portugal;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Italy;Switzerland;France;Australia;South Africa;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan | |||
| 152 | EUCTR2017-004230-28-BE | 09/03/2018 | 17 September 2018 | BI 655130 induction treatment in patients with moderate-tosevere ulcerative colitis | A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy | Moderate-to-severely active ulcerative colitis;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Code: BI 655130 Pharmaceutical Form: Solution for infusion INN or Proposed INN: BI 655130 Current Sponsor code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | SCS Boehringer Ingelheim Comm. V | Authorised | Female: yes Male: yes | 550 | Phase 2;Phase 3 | United States;Taiwan;Spain;Austria;Russian Federation;United Kingdom;Italy;Canada;Belgium;Poland;Germany;Netherlands;Japan;Korea, Republic of | |||
| 153 | NCT03444311 | March 8, 2018 | 11 June 2018 | Combined Nutritional Therapies for the Treatment of Ulcerative Colitis | Development of Combined Nutritional Therapies for the Treatment of Ulcerative Colitis Through the Increase of the Biodiversity of the Microbiota. | Colitis, Ulcerative | Dietary Supplement: A: 1 dosis;Dietary Supplement: B: 2 dosis | AB Biotics, SA | Recruiting | 18 Years | 65 Years | All | 40 | N/A | Spain | |
| 154 | NCT03398148 | March 7, 2018 | 4 November 2019 | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy | A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy | Ulcerative Colitis (UC) | Drug: risankizumab IV;Drug: placebo for risankizumab;Drug: risankizumab SC | AbbVie | Recruiting | 16 Years | 80 Years | All | 720 | Phase 2/Phase 3 | United States;Argentina;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;China;Colombia;Croatia;Denmark;Egypt;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom;American Samoa;Australia;Czechia;Hungary | |
| 155 | NCT03412682 | March 2, 2018 | 30 September 2019 | To Evaluate the Efficacy and Safety of FE 999315 in Japanese Subjects With Mild to Moderate Active Ulcerative Colitis | A Phase 3, Multi-centre, Randomised, Double-blind, Active-controlled, Parallel-group Trial Investigating the Efficacy and Safety of FE 999315 Following 8 Weeks of Treatment for Mild to Moderate Active Ulcerative Colitis in Japanese Subjects | Colitis, Ulcerative | Drug: Budesonide (6 mg);Drug: Budesonide (9 mg);Drug: Mesalazine (3,600 mg) | Ferring Pharmaceuticals | Recruiting | 16 Years | 75 Years | All | 273 | Phase 3 | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 156 | NCT03460847 | March 1, 2018 | 15 July 2019 | Fecal Microbiota Alterations in Steroid Refractory Active Colitis Ulcerosa | Can Fecal Microbiota Alterations Predict a Refractory Disease Course to Standard Steroid Therapy in Patients With Active Ulcerative Colitis? | Colitis, Ulcerative | Drug: Steroids | Medical University of Graz | Recruiting | 18 Years | N/A | All | 200 | N/A | Austria | |
| 157 | NCT03378921 | February 27, 2018 | 3 December 2018 | Fecal Microbiota Transplantation in the Treatment of Pouchitis | Double-blinded Randomized Placebo Controlled Study: Fecal Microbiota Transplantation in the Treatment of Chronic Pouchitis | Pouchitis;Ulcerative Colitis | Biological: Fecal microbiota transplantation;Biological: Placebo | Helsinki University Central Hospital | Not recruiting | 18 Years | 75 Years | All | 26 | Phase 2 | Finland | |
| 158 | NCT03801928 | February 23, 2018 | 21 January 2019 | Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease | OBSERVATIONAL, REAL WORLD STUDY OF INFLECTRA IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) IN THE UNITED STATES AND CANADA | Inflammatory Bowel Disease (IBD);Crohn's Disease (CD);Ulcerative Colitis (UC) | Drug: Inflectra | Pfizer | Recruiting | 18 Years | N/A | All | 300 | Phase 2 | United States | |
| 159 | NCT03849599 | February 21, 2018 | 25 March 2019 | A Study to Evaluate the Safety of PRV-300 in Adult Subjects With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Study to Evaluate the Safety of PRV-300 Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Biological: PRV-300;Biological: Placebo | Provention Bio, Inc. | Not recruiting | 18 Years | 75 Years | All | 37 | Phase 1 | Georgia;Moldova, Republic of;Ukraine | |
| 160 | NCT03259334 | February 9, 2018 | 11 November 2019 | Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 301) | Ulcerative Colitis | Drug: SHP647;Other: Placebo | Shire | Recruiting | 16 Years | 80 Years | All | 825 | Phase 3 | United States;Australia;Austria;Brazil;Croatia;Czechia;Germany;Israel;Italy;Japan;Lithuania;Netherlands;Poland;Romania;Russian Federation;Serbia;South Africa;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 161 | NCT03235752 | February 6, 2018 | 15 July 2019 | Safety and Efficacy of TJ301 IV in Participants With Active Ulcerative Colitis | A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of TJ301 (FE 999301) Administered Intravenously in Patients With Active Ulcerative Colitis | Active Ulcerative Colitis | Drug: TJ301 300mg;Drug: TJ301 600mg;Drug: Placebo | I-Mab Biopharma HongKong Limited | Recruiting | 18 Years | 70 Years | All | 90 | Phase 2 | Australia;China;Korea, Republic of;Taiwan | |
| 162 | EUCTR2017-004772-65-DK | 05/02/2018 | 30 April 2019 | Probiotic Treatment of Ulcerative Colitis with Trichuris suis ova (TSO) | Probiotic Treatment of Ulcerative Colitis with Trichuris suis ova (TSO) - PROCTO | Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TSO Pharmaceutical Form: Suspension for oral suspension INN or Proposed INN: TSO Other descriptive name: SUSPENSION CONTAINING 7500 EMBRYONATED VIABLE TRICHURIS SUIS OVA/15ML Concentration unit: IU/ml international unit(s)/millilitre Concentration type: range Concentration number: 450-550 Pharmaceutical form of the placebo: Suspension for oral suspension Route of administration of the placebo: Oral use | ParaTech A/S | Authorised | Female: yes Male: yes | 120 | Phase 2 | Denmark | |||
| 163 | JPRN-JapicCTI-183858 | 01/2/2018 | 16 July 2019 | Prospective, Post Marketing Surveillance of RECTABUL2mg rectal form | Prospective, Post Marketing Surveillance of RECTABUL2mg rectal form | Ulcerative colitis (except for severe disease) | Intervention name : RECTABUL2mg rectal form INN of the intervention : Budesonide Dosage And administration of the intervention : Usually, this drug is administered 2 times (1time 2mg) daily through rectal. | EA Pharma Co.,Ltd. | KISSEI Pharmaceutical Co., Ltd. | Recruiting | BOTH | 600 | NA | |||
| 164 | JPRN-UMIN000030988 | 2018/02/01 | 2 April 2019 | Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy | Ulcerative Colitis | Induce azathioprine and continue maintenance therapy by azathioprine Induce adalimumab and continue maintenance therapy by adalimumab | Sakura Medical Center, Toho university | Not Recruiting | 15years-old | Not applicable | Male and Female | 53 | Not applicable | Japan | ||
| 165 | EUCTR2017-000599-27-LT | 30/01/2018 | 28 February 2019 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 301). | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects with Moderate to Severe Ulcerative Colitis (FIGARO UC 301) | Ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Shire Human Genetic Therapies, Inc. | Authorised | Female: yes Male: yes | 825 | Phase 3 | Serbia;United States;Slovakia;Greece;Lithuania;Austria;Russian Federation;Israel;Italy;United Kingdom;Czech Republic;Poland;Brazil;Romania;Croatia;Australia;South Africa;Netherlands;Germany;New Zealand;Japan | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 166 | EUCTR2017-000402-38-DE | 23/01/2018 | 28 February 2019 | A clinical trail to evaluate the testicular safety of Filgotinib in adult males with Ulcerative Colitis | A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Testicular Safety of Filgotinib in Adult Males with Moderately to Severely Active Ulcerative Colitis | To evaluate the testicular safety of filgotinib in adult males with ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GS-6034 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: FILGOTINIB Current Sponsor code: GS-6034 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Gilead Sciences, Inc. | Authorised | Female: no Male: yes | 250 | Phase 2 | Portugal;United States;Spain;Ukraine;Austria;Russian Federation;Sri Lanka;Switzerland;United Kingdom;Italy;India;France;Canada;Belgium;Poland;Australia;Germany;Netherlands;New Zealand;Sweden | |||
| 167 | NCT03368118 | January 20, 2018 | 15 April 2019 | Study Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative Colitis | A Follow-up Phase IIa Study to Evaluate the Long-term Safety and Efficacy Profile of ABX464 Given at 50 mg Once Daily in Subjects With Moderate to Severe Active Ulcerative Colitis. | Ulcerative Colitis | Drug: ABX464 | Abivax S.A. | Orion Corporation, Orion Pharma | Not recruiting | 18 Years | 70 Years | All | 30 | Phase 2 | Belgium |
| 168 | EUCTR2017-002231-41-BE | 10/01/2018 | 20 August 2018 | A study to investigate how the body responds to the study drug Vedolizumab in child patients with Ulcerative Colitis or Crohn’s Disease | A Phase 2, Randomized, Double-Blind, Dose-Ranging Study to Determine the Pharmacokinetics, Safety and Tolerability of Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease (A Phase 2, Randomized, Double-Blind, Dose-Ranging Study With Vedolizumab IV in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease) - Hubble | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Vedolizumab CAS Number: 943609-66-3 Current Sponsor code: MLN0002 Other descriptive name: VEDOLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Vedolizumab CAS Number: 943609-66-3 Current Sponsor code: MLN0002 Other descriptive name: VEDOLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Vedolizumab CAS Number: 943609-66-3 Current Sponsor code: MLN0002 Other descriptive name: VEDOLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Trade Name: Entyvio Product Name: Vedolizumab IV Product Code: MLN0002 Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Vedolizumab CAS Number: 943609-66-3 Current Sponsor code: MLN0002 Other descriptive name: VEDOLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Takeda Development Centre Europe, Ltd. | Authorised | Female: yes Male: yes | 80 | Phase 2 | United Kingdom;Germany;Netherlands;Israel;Ukraine;Belgium;Poland;Canada;Hungary;United States;France | |||
| 169 | EUCTR2017-003284-35-HU | 03/01/2018 | 28 February 2019 | A follow-up study in patients with moderate to severe active ulcerative colitis. | A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis. - A Follow-up study in Moderate to Severe Active Ulcerative Colitis subjects | Moderate to severe Ulcerative Colitis. MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 Pharmaceutical Form: Capsule, hard INN or Proposed INN: ABX464 Current Sponsor code: ABX464 Other descriptive name: ABX464 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | ABIVAX | Authorised | Female: yes Male: yes | 30 | Phase 2 | Hungary;Spain;Poland;Belgium | |||
| 170 | JPRN-UMIN000030000 | 2018/01/01 | 2 April 2019 | The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis. | ulcerative colitis pouchitis | Topical budesonido 2weeks of 2mg daily Topical prednisolone 2weeks 20mg daily Topical aminosalicylate 2weeks 1g daily | Department of Inflammatory Bowel Disease Hyogo College of Medicine | Not Recruiting | Not applicable | Not applicable | Male and Female | 30 | Phase 1 | Japan | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 171 | NCT03394586 | January 1, 2018 | 22 January 2018 | Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab | Real-world Data Regarding Treatment of Ulcerative Colitis Patients With Golimumab | Ulcerative Colitis;Flare Up, Symptom | Drug: Exposure to golimumab | University of Zurich | Recruiting | N/A | N/A | All | 100 | N/A | Switzerland | |
| 172 | NCT03309865 | December 25, 2017 | 1 October 2018 | Evaluating the Combined Effect of Vedolizumab and Semi-Vegetarian Diet on Ulcerative Colitis. | A Pilot Study Evaluating the Synergistic Effect of Vedolizumab in Conjunction With Structured Semi-Vegetarian Diet on the Treatment of Ulcerative Colitis. | Ulcerative Colitis;Dietary Modification | Dietary Supplement: semi-vegetarian diet;Drug: Vedolizumab Injection | Mayo Clinic | Not recruiting | 18 Years | N/A | All | 0 | Early Phase 1 | United States | |
| 173 | NCT03269695 | December 20, 2017 | 11 November 2019 | Efficacy, Safety and Tolerability of PF-06687234 as Add-on Therapy to Infliximab in Active UC Subjects Not in Remission. | A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06687234 AS ADD-ON THERAPY TO INFLIXIMAB IN ACTIVE ULCERATIVE COLITIS SUBJECTS WHO ARE NOT IN REMISSION (BUILD UC) | Ulcerative Colitis | Drug: PF-06687234;Drug: Placebo | Pfizer | Recruiting | 18 Years | 75 Years | All | 76 | Phase 2 | United States;Australia;Belgium;Germany;Israel;Italy;Korea, Republic of;Saudi Arabia;Serbia;Spain | |
| 174 | EUCTR2014-001594-14-DE | 19/12/2017 | 23 July 2018 | Can FITC-Adalimumab predict the efficacy of Adalimumab in patients with colitis ulcerosa, when it is applied to the intestinal mucosa during an endoscopic examination? Is FITC-Adalimumab safe and tolerable in this setting? Open-label, one-arm clinical trial in one study site | Prospective, single-centre, open-label, one-arm clinical trial, phase I/IIa, to assess the safety and tolerability and to investigate the predictive power of FITC-Adalimumab, when topically applied twice to the intestinal mucosa as an in-vitro diagnostic in the framework of a confocal laser-endomicroscopic examination of colitis ulcerosa patients with an indication for Adalimumab treatment - MAgIC | Ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: FITC-Adalimumab Product Code: FITC-Adalimumab Pharmaceutical Form: Gastroenteral solution INN or Proposed INN: FITC-Adalimumab Other descriptive name: FITC-ADALIMUMAB Concentration unit: µg/µl microgram(s)/microlitre Concentration type: equal Concentration number: 2.5- | Universitätsklinikum Erlangen | Authorised | Female: yes Male: yes | 25 | Phase 1;Phase 2 | Germany | |||
| 175 | EUCTR2017-003284-35-BE | 19/12/2017 | 7 January 2019 | A follow-up study in patients with moderate to severe active ulcerative colitis. | A follow-up Phase IIa study to evaluate the long-term safety and efficacy profile of ABX464 given at 50 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis. - Follow-up study in Moderate to Severe Active Ulcerative Colitis subjects | Moderate to severe Ulcerative Colitis. MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 Pharmaceutical Form: Capsule, hard INN or Proposed INN: ABX464 Current Sponsor code: ABX464 Other descriptive name: ABX464 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | ABIVAX | Authorised | Female: yes Male: yes | 30 | Phase 2 | Hungary;Spain;Poland;Belgium | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 176 | JPRN-UMIN000032250 | 2017/12/15 | 2 April 2019 | Dual center study of usefulness of probe-based confocal laser endomicroscopy for suspected ulcerative colitis-associated neoplasia | Dual center study of usefulness of probe-based confocal laser endomicroscopy for suspected ulcerative colitis-associated neoplasia - Dual center study of pCLE for UCAN | suspected ulcerative colitis-associated neoplasia | pCLE after intravenous administration of fluorescein | Fujita Health University School of Medicine, Department of Gastroenterology | Center for Diagnostic and Therapeutic Endoscopy, School of Medicine Keio University | Recruiting | 20years-old | 85years-old | Male and Female | 40 | Not applicable | Japan |
| 177 | JPRN-jRCTs041180035 | 15/12/2017 | 10 September 2019 | Dual center study of pCLE for UCAN | Dual center study of usefulness of probe-based confocal laser endomicroscopy for suspected ulcerative colitis-associated neoplasia | suspected ulcerative colitis-associated neoplasia | pCLE after intravenous administration of fluorescein | Naoki Ohmiya | Recruiting | 20years old or older | Under 80 years old | Both | 40 | N/A | none | |
| 178 | NCT03259308 | December 5, 2017 | 11 November 2019 | Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis | A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 302) | Ulcerative Colitis | Drug: SHP647;Drug: Placebo | Shire | Recruiting | 16 Years | 80 Years | All | 825 | Phase 3 | United States;Argentina;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Estonia;France;Greece;Hungary;Ireland;Japan;Korea, Republic of;Mexico;New Zealand;Portugal;Slovakia;Spain;Switzerland;Ukraine | |
| 179 | NCT02559713 | November 29, 2017 | 11 March 2019 | Postmarketing Vedolizumab Milk-Only Lactation Study in Lactating Women With Active Ulcerative Colitis or Crohn's Disease | An Open-Label, Multicenter and Open Enrollment Model, Postmarketing, Milk-Only Lactation Study to Assess Concentration of Vedolizumab in Breast Milk of Lactating Women With Active Ulcerative Colitis or Crohn's Disease Who Are Receiving Vedolizumab Therapeutically | Colitis, Ulcerative;Crohn Disease | Drug: Vedolizumab | Takeda | Not recruiting | 18 Years | N/A | Female | 11 | Phase 4 | United States | |
| 180 | NCT03182166 | November 21, 2017 | 15 July 2019 | Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization | Pharmacokinetic and Pharmacodynamic Study of Golimumab in Ulcerative Colitis (UC) Patients With Loss of Response (LOR) Followed by Dose Optimization | Ulcerative Colitis | Drug: Golimumab (Optimization);Diagnostic Test: Rectosigmoidoscopy;Biological: Blood samples | Centre Hospitalier Universitaire de Saint Etienne | Merck Sharp & Dohme Corp. | Recruiting | 18 Years | N/A | All | 80 | Phase 2 | France |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 181 | NCT03408847 | November 20, 2017 | 19 February 2018 | Monocultivar Coratina Extra Virgin Olive Oil in UC Patients | Supplementation of Extra Virgin Olive Oil Monocultivar Coratina in Patients With Active Ulcerative Colitis | Ulcerative Colitis Chronic Mild | Combination Product: Beclomethasone dipropionate in addition to MC-EVOO;Combination Product: Beclomethasone dipropionate in addition to refined oil | Casa Sollievo della Sofferenza IRCCS | Fondazione Schena | Recruiting | 18 Years | 70 Years | All | 30 | N/A | Italy |
| 182 | NCT03281304 | November 16, 2017 | 22 October 2019 | A Study of Tofacitinib in Patients With Ulcerative Colitis in Stable Remission | A PHASE 3B/4,MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP STUDY OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ULCERATIVE COLITIS IN STABLE REMISSION | Ulcerative Colitis | Drug: CP-690,500 5 mg;Drug: CP-690,550 10 mg | Pfizer | Recruiting | 18 Years | N/A | All | 130 | Phase 4 | United States;Belgium;Canada;Czechia;France;Germany;Hungary;Italy;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom | |
| 183 | NCT03266484 | November 13, 2017 | 18 March 2019 | Effect of a Probiotic Mixture on the Gut Microbiome and Fatigue in Patients With Quiescent Inflammatory Bowel Disease | Effect of Dietary Therapy With a Probiotic Mixture on the Gut Microbiome and Fatigue Symptoms in Patients With Quiescent Inflammatory Bowel Disease - A Clinical Trial | Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis | Dietary Supplement: Probiotic Mixture;Dietary Supplement: Placebo | Massachusetts General Hospital | Winclove Bio Industries BV | Recruiting | 18 Years | 75 Years | All | 100 | N/A | United States |
| 184 | JPRN-JapicCTI-173802 | 01/11/2017 | 16 July 2019 | Active phase study of MD-0901 in pediatric ulcerative colitis. | The clinical study to evaluate the efficacy, safety, and pharmacokinetics of MD-0901 in pediatric patients with mildly to moderately active ulcerative colitis. | Mildly to moderately active ulcerative colitis | Intervention name : MD-0901 INN of the intervention : mesalazine Dosage And administration of the intervention : Mesalazine 80 mg/day are administrated orally once daily after breakfast for 8 weeks. | MOCHIDA PHARMACEUTICAL CO., LTD | Recruiting | 16 | BOTH | 26 | Phase 2-3 | |||
| 185 | JPRN-JapicCTI-173803 | 01/11/2017 | 16 July 2019 | Maintenance phase study of MD-0901 in pediatric ulcerative colitis. | The clinical study to evaluate the efficacy, safety, and pharmacokinetics of MD-0901 in pediatric patients with ulcerative colitis in remission. | Ulcerative colitis in remission | Intervention name : MD-0901 INN of the intervention : mesalazine Dosage And administration of the intervention : Mesalazine 40 mg/day are administrated orally once daily after breakfast for 48 weeks. | MOCHIDA PHARMACEUTICAL CO., LTD | Recruiting | 16 | BOTH | 26 | Phase 2-3 | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 186 | EUCTR2016-002691-27-NL | 19/10/2017 | 6 November 2017 | An open label study to study changes in the structure of the mucosa of the bowel in subjects during treatment with tofacitinib for moderate to severe ulcerative colitis | An open label exploratory analysis of the histological, immunological and microbiome changes of the colonic mucosa during treatment with tofacitinib for moderate-severe ulcerative colitis - TOFA-histo | Ulcerative colitis MedDRA version: 20.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Xeljanz 5 mg film-coated tablets | Academic Medical Center | Authorised | Female: yes Male: yes | 40 | Phase 3 | Netherlands | |||
| 187 | NCT03172195 | October 11, 2017 | 1 October 2018 | Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up | Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up | Colitis, Ulcerative | Procedure: rectosigmoidoscopy;Biological: biopsies;Biological: blood sample | Centre Hospitalier Universitaire de Saint Etienne | Recruiting | 18 Years | N/A | All | 100 | N/A | France | |
| 188 | NCT03093259 | October 1, 2017 | 18 December 2018 | ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis | Phase IIa Study to Evaluate the Safety and Efficacy of ABX464 Versus Placebo in Subjects With Moderate to Severe Active Ulcerative Colitis Who Have Failed or Are Intolerant to Immunomodulators, Anti-TNFa, Vedolizumab and/or Corticosteroids | Ulcerative Colitis | Drug: ABX464;Drug: Placebo oral capsule | Abivax S.A. | Not recruiting | 18 Years | 70 Years | All | 32 | Phase 2 | Belgium | |
| 189 | EUCTR2017-000937-30-BE | 29/09/2017 | 20 August 2018 | Investigate the efficacy and safety of study drug ABX464 50 mg once daily versus placebo with patients with moderate to severe Active Ulcerative Colitis. | A Phase IIa study to evaluate the safety and efficacy of ABX464 50 mg once daily versus Placebo in subjects with Moderate to Severe Active Ulcerative Colitis who have failed or are intolerant to immunomodulators, Anti-TNFa, vedolizumab and/or corticosteroids. - Safety and efficacy study of ABX464 in patients with moderate to severe Active Ulcerative Colitis. | Moderate to severe Ulcerative Colitis. MedDRA version: 20.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: ABX464 Pharmaceutical Form: Capsule, hard INN or Proposed INN: ABX464 Current Sponsor code: ABX464 Other descriptive name: ABX464 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | ABIVAX | Authorised | Female: yes Male: yes | 30 | Phase 2 | Germany;Austria;Belgium;Poland;Spain;Hungary | |||
| 190 | NCT03494764 | September 7, 2017 | 11 November 2019 | Hyperbaric Oxygen Therapy for Ulcerative Colitis Flares | Hyperbaric Oxygen Therapy for Moderate to Severe Ulcerative Colitis Flares: A Multi-Center Randomized Trial | Colitis, Ulcerative | Other: Hyperbaric Oxygen Therapy | Dartmouth-Hitchcock Medical Center | Foundation for Clinical Research in IBD;The Eli and Edythe Broad Foundation;University of California, San Diego;Mayo Clinic;University of Pittsburgh Medical Center;Virginia Mason Memorial Hospital;University of Texas Southwestern Medical Center | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 191 | NCT03124121 | September 5, 2017 | 26 August 2019 | Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels | Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels | Ulcerative Colitis | Drug: Golimumab | Guy's and St Thomas' NHS Foundation Trust | Merck Sharp & Dohme Corp. | Recruiting | 18 Years | N/A | All | 84 | Phase 4 | United Kingdom |
| 192 | NCT03221036 | August 3, 2017 | 29 April 2019 | Efficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of Intravenous Vedolizumab (300 mg) Infusion Treatment in Chinese Subjects With Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis | Drug: Vedolizumab IV;Drug: Placebo | Takeda | Recruiting | 18 Years | 80 Years | All | 302 | Phase 3 | China | |
| 193 | NCT03162432 | August 1, 2017 | 30 September 2019 | High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade | High Dose Interval Vitamin D Supplementation in Patients With IBD Receiving Remicade | IBD;Ulcerative Colitis;Crohn Disease | Drug: Vitamin D3 | Boston Children’s Hospital | Recruiting | 7 Years | 25 Years | All | 50 | Phase 3 | United States | |
| 194 | NCT03237260 | July 1, 2017 | 15 July 2019 | An Open Label Single-arm Phase 4 Study of Vedolizumab in Subjects With Newly Diagnosed Active Ulcerative Colitis | An Open Label Single-arm Phase 4 Study of Vedolizumab in Subjects With Newly Diagnosed Active Ulcerative Colitis | Ulcerative Colitis | Drug: Vedolizumab | University of Pennsylvania | Takeda;Corporal Michael J. Crescenz VA Medical Center | Not recruiting | 18 Years | 80 Years | All | 0 | Phase 4 | United States |
| 195 | JPRN-UMIN000026175 | 2017/06/23 | 2 April 2019 | Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis | Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis - Comparison of concentration of 5-ASA and acetyl 5-ASA in mucosa in time-dependent mesalazine granule preparation and pH-dependent mesalazine tablet for patients with ulcerative colitis | Ulcerative colitis | Time dependent mesalazine granule formulation After bottom of the 8th week from the start of administration, the lower endoscopy was performed and the mucous membrane was collected from the cecum and rectum by biopsy and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured in the mucosa . PH dependent mesalazine granule preparation Lower endoscopy was performed 8 weeks after the start of administration, mucosa was collected from the cecum and rectum by biopsy, and the concentration of 5-ASA and acetyl 5-ASA in the mucosa was measured at the drug part . | Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University | Not Recruiting | 20years-old | 99years-old | Male and Female | 60 | Not applicable | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 196 | NCT03178669 | June 21, 2017 | 26 August 2019 | The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis | A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients | Ulcerative Colitis | Drug: cobitolimod;Drug: Placebo | InDex Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 213 | Phase 2 | Czechia;France;Germany;Hungary;Poland;Russian Federation;Serbia;Spain;Sweden;Ukraine | |
| 197 | NCT03104036 | June 19, 2017 | 11 November 2019 | Faecal Bacteriotherapy for Ulcerative Colitis | Faecal Bacteriotherapy for Ulcerative Colitis | Ulcerative Colitis | Other: Faecal bacterial transplantation;Drug: Mesalazine 4G Enema | Institute for Clinical and Experimental Medicine | Institute of Animal Physiology and Genetics Academy of Science Czech Republic | Recruiting | 18 Years | 70 Years | All | 60 | Phase 2 | Czechia;Czech Republic |
| 198 | NCT03122613 | June 19, 2017 | 15 July 2019 | Curcumin for Prevention of Relapse in Patients With Ulcerative Colitis | A Double-blind, Randomized, Placebo-Controlled Trial of Curcumin Versus Placebo for Prevention of Relapse in Patients With Ulcerative Colitis | Ulcerative Colitis in Remission | Dietary Supplement: Curcumin;Drug: Placebo | Chinese University of Hong Kong | Recruiting | 18 Years | N/A | All | 172 | N/A | Hong Kong | |
| 199 | EUCTR2016-004572-21-DK | 07/06/2017 | 30 April 2019 | A study in patients with mild or moderate ulcerative colitis who take a TNF inhibitor. The study investigates whether bowel inflammation improves when patients take BI 655130 in addition to their current therapy. | Proof-of-concept study of BI 655130 add-on treatment in patients with mild-to-moderately active ulcerative colitis during TNF inhibitor therapy | Mild-to-moderately active ulcerative colitis on TNF inhibitor therapy MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 Pharmaceutical Form: Solution for infusion INN or Proposed INN: BI 655130 Current Sponsor code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Boehringer Ingelheim Pharma GmbH & Co. KG | Authorised | Female: yes Male: yes | 30 | Phase 2 | United Kingdom;Norway;Germany;Netherlands;Denmark;Spain | |||
| 200 | NCT03123120 | June 7, 2017 | 28 October 2019 | A Study in Patients With Mild or Moderate Ulcerative Colitis Who Take a TNF Inhibitor. The Study Investigates Whether Bowel Inflammation Improves When Patients Take BI 655130 in Addition to Their Current Therapy | Proof-of-concept Study of BI 655130 add-on Treatment in Patients With Mild-to-moderately Active Ulcerative Colitis During TNF Inhibitor Therapy | Colitis, Ulcerative | Drug: Spesolimab;Drug: Placebo | Boehringer Ingelheim | Recruiting | 18 Years | 75 Years | All | 30 | Phase 2 | Denmark;Germany;Netherlands;Norway;Spain;United Kingdom;Ireland | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 201 | EUCTR2017-000100-20-DE | 06/06/2017 | 20 August 2018 | This study tests how BI 655130 works in patients with active ulcerative colitis. The study also tests how well BI 655130 is tolerated and whether it helps the patients. | Exploratory Trial to Assess Mechanism of Action, Clinical Effect, Safety and Tolerability of 12 Weeks of Treatment with BI 655130 in Patients with Active Ulcerative Colitis (UC) | Active ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: BI 655130 Product Code: BI 655130 Pharmaceutical Form: Solution for infusion INN or Proposed INN: BI 655130 Current Sponsor code: BI 655130 Other descriptive name: MONOCLONAL ANTIBODY ANTI-IGG1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1200- | Boehringer Ingelheim Pharma GmbH & Co. KG | Authorised | Female: yes Male: yes | 10 | Phase 2 | Belgium;Germany;United Kingdom | |||
| 202 | NCT03299413 | June 5, 2017 | 23 April 2019 | Use of Mesenchymal Stem Cells in Inflammatory Bowel Disease | Ulcerative Colitis Stem Cell Therapy | Inflammatory Bowel Diseases | Biological: Wharton Jelly Mesenchymal stem cells | Hanan Jafar | Scientific Research Support fund | Not recruiting | 18 Years | 75 Years | All | 20 | Phase 1/Phase 2 | Jordan |
| 203 | JPRN-UMIN000027465 | 2017/05/29 | 2 April 2019 | Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis | Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis - Efficacy and safety of IFX-BS in UC patients | ulcerative colitis | Infliximab (5mg/kg, every 8 weeks, for 12 months) Biosimilar Infliximab (5mg/kg, every 8 weeks, for 12 months) | University of Toyama | Not Recruiting | 20years-old | Not applicable | Male and Female | 20 | Not selected | Japan | |
| 204 | NCT02954159 | May 18, 2017 | 3 June 2019 | Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in UC | Induction of Response and Remission of Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in Patients With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Tacrolimus;Drug: Vedolizumab;Other: Placebo | Medical College of Wisconsin | Takeda | Not recruiting | 18 Years | 65 Years | All | 4 | Phase 3 | United States |
| 205 | EUCTR2017-000330-61-ES | 16/05/2017 | 3 July 2017 | Effect of Beclometasone dipropionate (BDP) on faecal Calprotectin levels in patients with clinically inactive Ulcerative Colitis at risk of relapse. BeCalCU study | Effect of Beclometasone dipropionate (BDP) on faecal Calprotectin levels in patients with clinically inactive Ulcerative Colitis at risk of relapse. BeCalCU study - BeCalCU | Clinically inactive Ulcerative Colitis at risk of relapse MedDRA version: 19.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Clipper Product Name: Beclometasone dipropionate Pharmaceutical Form: Tablet INN or Proposed INN: BECLOMETASONE DIPROPIONATE CAS Number: 5534-09-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | CHIESI ESPAÑA S.A.U. | Authorised | Female: yes Male: yes | Phase 3 | Spain | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 206 | NCT03327558 | May 15, 2017 | 11 June 2018 | Randomized,Study of APRISO 375 mg Versus the Approved APRISO 375 mg Capsules in Healthy Male and Female Subjects | Full-replicate Study of APRISO 375 mg Extended-release Capsules Versus the Approved APRISO 375 mg Extended-release Capsules in Healthy Male and Female Subjects | Ulcerative Colitis | Drug: Apriso 0.375G ER CAP;Drug: APRISO 375 mg extended-release capsules | Valeant Pharmaceuticals International, Inc. | Not recruiting | 18 Years | N/A | All | 60 | Phase 1 | United States | |
| 207 | NCT03151525 | May 8, 2017 | 16 December 2017 | Two Therapeutic Strategies for the Maintenance of Remission in Patients With Ulcerative Colitis | Comparison Between Two Therapeutic Strategies for the Maintenance of Clinical and Endoscopic Remission in Patients With Ulcerative Colitis Treated by Infliximab | Colitis, Ulcerative | Drug: Azathioprine;Drug: Infliximab | Istituto Clinico Humanitas | Agenzia Italiana del Farmaco | Recruiting | 18 Years | 65 Years | All | 100 | Phase 4 | Italy |
| 208 | NCT03103412 | May 4, 2017 | 16 December 2017 | TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC) | Study 0146: A Phase 1a, Double-Blinded, Randomized, Placebo Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, and Systemic Exposure of TD-3504 in Healthy Subjects and Subjects With Ulcerative Colitis (UC) | Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy Subjects | Drug: TD-3504;Drug: 15N2-tofacitinib;Drug: Placebo | Theravance Biopharma R & D, Inc. | Not recruiting | 18 Years | 55 Years | All | 32 | Phase 1 | United States | |
| 209 | NCT03059849 | May 1, 2017 | 16 December 2017 | Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD | Brief Escalation of Adalimumab Treatment for Prevention of Clinical Relapse in IBD | Crohn Disease;Ulcerative Colitis | Drug: Adalimumab | McMaster University | Not recruiting | 18 Years | 80 Years | All | 290 | Phase 4 | ||
| 210 | NCT03110198 | May 2017 | 16 December 2017 | Mesalazine With Hydrocortisone Sodium Succinate Enema for 4-Week Treatment in Patients With Ulcerative Colitis | A Randomized, Double-blind Study Investigating the Efficacy and Safety of Mesalazine With Hydrocortisone Sodium Succinate (100mg QD) Enema for 4-Week Treatment in Patients With Ulcerative Colitis (UC) | Ulcerative Colitis, Unspecified | Drug: Mesalazine;Drug: hydrocortisone sodium succinate;Drug: Mesalazine with hydrocortisone sodium succinate | Xijing Hospital of Digestive Diseases | Shanghai Tongji Hospital, Tongji University School of Medicine;First Affiliated Hospital of Zhongshan Medical University | Recruiting | 18 Years | 70 Years | All | 528 | Phase 4 | China |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 211 | NCT03415711 | April 28, 2017 | 5 February 2018 | PRObiotic VSL#3® for Maintenance of Clinical and Endoscopic REMission in Ulcerative Colitis | A Double-blind, Randomized, Placebo-controlled, Single-center, Dose-finding, Pilot Study Evaluating the Efficacy of VSL#3® in the Maintenance of Clinical and Endoscopic Remission of Mild-to-moderate UC | Ulcerative Colitis | Dietary Supplement: VSL#3®;Drug: Mesalamine;Drug: Placebo | VSL Pharmaceuticals | Actial Farmaceutica S.r.l. | Recruiting | 18 Years | 85 Years | All | 39 | N/A | Italy |
| 212 | EUCTR2016-004217-26-DE | 21/04/2017 | 24 September 2018 | A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients | A Randomised Dose-Optimisation Study to Evaluate the Efficacy and Safety of Cobitolimod in Moderate to Severe Active Ulcerative Colitis Patients - CONDUCT | Moderate to Severe left-sided Active Ulcerative Colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Cobitolimod Product Code: DIMS0150 Pharmaceutical Form: Rectal solution INN or Proposed INN: Cobitolimod CAS Number: 1527479-55-5 Current Sponsor code: DIMS0150 Other descriptive name: DIMS0150 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 31- Pharmaceutical form of the placebo: Rectal solution Route of administration of the placebo: Rectal use Product Name: Cobitolimod Product Code: DIMS0150 Pharmaceutical Form: Rectal solution INN or Proposed INN: Cobitolimod CAS Number: 1527479-55-5 Current Sponsor code: DIMS0150 Other descriptive name: DIMS0150 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical form of the placebo: Rectal solution Route of administration of the placebo: Rectal use Product Name: Cobitolimod Product Code: DIMS0150 Pharmaceutical Form: Rectal solution INN or Proposed INN: Cobitolimod CAS Number: 1527479-55-5 Current Sponsor code: DIMS0150 Other descriptive name: DIMS0150 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Rectal solution Route of administration of the placebo: Rectal use | InDex Pharmaceuticals AB | Authorised | Female: yes Male: yes | 215 | Phase 2 | Sweden;Italy;Germany;Russian Federation;Romania;Ukraine;Spain;Poland;Czech Republic;Hungary;France;Serbia | |||
| 213 | NCT02994836 | April 21, 2017 | 27 May 2019 | GIS-SUSANTI-TNF-2015 (Anti-TNF Discontinuation ) | Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: Multicentre, Prospective, Randomized Clinical Trial and Economic Evaluation | Crohn's Disease;Inflammatory Bowel Disease;Ulcerative Colitis | Drug: Anti-TNF discontinuation: Physiological saline solution;Biological: Anti-TNF:Adalimumab (Subcutaneus);Biological: Anti-TNF: Infliximab (Infusion) | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Recruiting | 18 Years | N/A | All | 194 | Phase 4 | Spain | |
| 214 | EUCTR2016-001392-78-BE | 31/03/2017 | 28 February 2019 | A study to assess a new treatment in patients with moderately to Severely active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects with Moderately to Severely Active Ulcerative Colitis | Moderately to Severely Active Ulcerative Colitis (UC) MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Filgotinib Product Code: GS-6034 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Filgotinib Product Code: GS-6034 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: FILGOTINIB Other descriptive name: Filgotinib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Gilead Sciences, Inc. | Authorised | Female: yes Male: yes | 1300 | Phase 2;Phase 3 | Serbia;Portugal;United States;Belarus;Taiwan;Hong Kong;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Sri Lanka;Italy;Switzerland;India;France;Malaysia;Australia;South Africa;Netherlands;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Iceland;Germany;New Zealand;Japan;Sweden | |||
| 215 | NCT03029143 | March 29, 2017 | 11 November 2019 | Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis | A Phase 4 Open-Label Study to Evaluate Vedolizumab IV Dose Optimization on Treatment Outcomes In Nonresponders With Moderately to Severely Active Ulcerative Colitis (ENTERPRET) | Colitis, Ulcerative | Drug: Vedolizumab IV | Takeda | Not recruiting | 18 Years | 85 Years | All | 250 | Phase 4 | United States;Canada | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 216 | NCT03090139 | March 28, 2017 | 2 July 2018 | Sub-optimal Response to Anti-Tumor Necrosis Factor's in Inflammatory Bowel Disease in Emerging Markets | Indicators of Sub-Optimal Response to Anti-Tumor Necrosis Factor (TNF) Therapy in Patients With Crohn's Disease (CD) and Ulcerative Colitis (UC): A Retrospective Chart Review in the Emerging Market (EM) Region (EXPLORE) | Colitis, Ulcerative;Crohn Disease;Inflammatory Bowel Diseases | Drug: Anti-TNF Therapy | Takeda | Not recruiting | 18 Years | N/A | All | 1731 | Phase 3 | Argentina;China;Colombia;Korea, Republic of;Mexico;Russian Federation;Saudi Arabia;Singapore;Taiwan;Turkey | |
| 217 | NCT03006809 | March 2, 2017 | 26 November 2018 | Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis | Optimal Fecal Microbiota Transplant Dosing for Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Biological: Fecal Microbiota Transplantation (FMT), OpenBiome;Other: pretreatment antibiotics | Najwa Elnachef | Recruiting | 18 Years | 64 Years | All | 40 | Phase 1 | United States | |
| 218 | EUCTR2016-003797-40-BE | 23/02/2017 | 23 October 2017 | A clinical study to investigate the effectiveness and safety of treatment with the drug APD334 in ulcerative colitis and crohn's disease patients with skin conditions | A Phase 2a, Proof of Concept, Open-label Study Evaluating the Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients with active Skin Extra-intestinal Manifestations | Active Skin Extra-Intestinal Manifestations in Inflammatory Bowel Disease.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: APD334 Pharmaceutical Form: Tablet INN or Proposed INN: Not yet available CAS Number: 1206123 97 8 Current Sponsor code: APD334 Other descriptive name: APD334 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- | Arena Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United States;Belgium;Germany | |||
| 219 | NCT02914535 | February 23, 2017 | 11 November 2019 | Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis | A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis | Ulcerative Colitis | Drug: Filgotinib;Drug: Placebo | Gilead Sciences | Galapagos NV | Recruiting | 18 Years | N/A | All | 1000 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;France;Georgia;Germany;Greece;Hong Kong;Hungary;Iceland;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom;Czech Republic |
| 220 | EUCTR2016-003797-40-DE | 21/02/2017 | 15 October 2018 | A clinical study to investigate the effectiveness and safety of treatment with the drug APD334 in ulcerative colitis and crohn's disease patients with skin conditions | A Phase 2a, Proof of Concept, Open-label Study Evaluating the Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients with active Skin Extra-intestinal Manifestations | Active Skin Extra-Intestinal Manifestations in Inflammatory Bowel Disease.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: APD334 Pharmaceutical Form: Tablet INN or Proposed INN: Not yet available CAS Number: 1206123 97 8 Current Sponsor code: APD334 Other descriptive name: APD334 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- | Arena Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United States;Belgium;Germany | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 221 | EUCTR2016-003452-75-LV | 20/02/2017 | 30 April 2018 | A study to examine the safety and effect of the study drug PTG-100 in patients with inflammation of the colon | A PHASE 2B RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL ADAPTIVE 2-STAGE, MULTI-CENTRE STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL PTG-100 INDUCTION IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | Moderate to Severe Active Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PTG-100 Product Code: PTG-100 Pharmaceutical Form: Capsule, hard INN or Proposed INN: - Current Sponsor code: PTG-100 Other descriptive name: PN-10884A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: PTG-100 Product Code: PTG-100 Pharmaceutical Form: Capsule, hard INN or Proposed INN: - Current Sponsor code: PTG-100 Other descriptive name: PN-10884A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Protagonist Therapeutics, Inc | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Serbia;United States;Slovenia;Greece;Ukraine;Russian Federation;United Kingdom;Czech Republic;Hungary;Poland;Belgium;Croatia;Latvia;Germany;Netherlands;Bosnia and Herzegovina | |||
| 222 | NCT03071081 | February 8, 2017 | 1 October 2018 | Study for Safety and Tolerability of TOP1288 Administered Orally in Healthy Subjects | A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TOP1288 Oral Single Ascending and Multiple Doses in Healthy Volunteers | Ulcerative Colitis | Drug: TOP1288;Drug: Placebo to TOP1288 | Topivert Pharma Ltd | Not recruiting | 18 Years | 55 Years | Male | 37 | Phase 1 | United Kingdom | |
| 223 | NCT02958865 | February 3, 2017 | 11 November 2019 | Study to Compare Oral PF-06651600, PF-06700841 and Placebo in Subjects With Moderate to Severe Ulcerative Colitis | A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY OF ORAL PF-06651600 AND PF-06700841 AS INDUCTION AND CHRONIC THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative Colitis | Drug: PF-06651600 or Placebo;Drug: PF-06700841 or Placebo;Drug: PF-06700841;Drug: PF-06651600 | Pfizer | Recruiting | 18 Years | 75 Years | All | 360 | Phase 2 | United States;Austria;Bulgaria;Canada;Czechia;Denmark;Georgia;Germany;Hungary;Israel;Italy;Korea, Republic of;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Turkey;Ukraine | |
| 224 | ChiCTR-IPR-17010306 | 2017-02-01 | 18 April 2017 | Effects of probiotics on intestinal microecological reconstruction in patients with ulcerative colitis | Effects of probiotics on intestinal microecological reconstruction in patients with ulcerative colitis | Ulcerative colitis | Group A:Mesalazine combined with placebo; Group B:Methalazine combined with probiotics;Group C:Probiotics combined with placebo;Normal control group:Blank control; | Affiliated Hospital of Inner Mongolia Medical University | Not Recruiting | 18 | Both | Group A:30; Group B:30;Group C:30;Normal control group:30; | Post-market | China | ||
| 225 | JPRN-UMIN000025846 | 2017/02/01 | 2 April 2019 | A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease | ulcerative colitis, Crohn's disease | Administration of the fecal material from healthy donors to patients after taking three kinds of antibiotics (Amoxicillin, fosmycin, metronidazole) for two weeks | Juntendo university school of medicine Department of gastroenterology | Recruiting | 16years-old | Not applicable | Male and Female | 60 | Not selected | Japan | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 226 | JPRN-jRCTs031180415 | 01/02/2017 | 22 July 2019 | A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease | Single center non-randomized study: A trial of a combination therapy of fecal microbial transplantation and antibiotics for inflammatory bowel disease | Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease) Inflammatory Bowel Disease (Ulcerative Colitis, Crohn's Disease) | AFM therapy arm : three antibiotics, amoxicillin (1500 mg/day), fosfomycin (3000 mg/day) and metronidazole (750 mg/day) are administered orally to patients for 2 weeks. For pediatric patients, amoxicillin (50mg/kg), fosfomycin (120mg/kg) and metronidazole (20mg/kg) are administered orally for 2 weeks (the upper limit is the same amount as adults). FMT arm : Approximately 150 to 250 g of donor stool is diluted with saline (500 mL) and filtered to remove crude components. The diluted and filtered fecal suspension is transferred into the patients colon from cecum to rectum during total colonoscopy. As usual examinations, the patient undergoes biopsy of inflammatory site. A-FMT arm : Patient undergoes FMT two days after AFM therapy. | Dai Ishikawa | Recruiting | >=6 age old | Both | 120 | N/A | none | ||
| 227 | NCT03038711 | February 1, 2017 | 11 February 2019 | A Multiple Dose Study to Assess the Safety and Tolerability of BMS-986166 in Healthy Volunteers | A Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Subjects | Ulcerative Colitis | Drug: BMS-986166;Other: Placebo matching BMS-986166 | Bristol-Myers Squibb | Not recruiting | 18 Years | 55 Years | All | 213 | Phase 1 | United States | |
| 228 | NCT03006068 | January 31, 2017 | 27 May 2019 | A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis (UC) | A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects With Ulcerative Colitis | Ulcerative Colitis (UC) | Drug: Upadacitinib (ABT-494);Drug: Placebo | AbbVie | Recruiting | 16 Years | 75 Years | All | 950 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom | |
| 229 | NCT03000101 | January 19, 2017 | 21 January 2019 | Study of the Role of Pomegranate Juice Ellagitannins in the Modulation of Inflammation in Inflammatory Bowel Disease | New Insight and Knowledge on Anti-inflammatory Effectiveness of Dietary Phenolics (NIKE) | Crohn's Disease;Ulcerative Colitis | Other: placebo beverage;Other: 100% pomegranate juice | Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi | University of Bologna;Conserve Italia;GAT Foods | Not recruiting | 18 Years | 80 Years | All | 18 | N/A | Italy |
| 230 | NCT03798210 | January 1, 2017 | 21 January 2019 | Lactobacillus Reuteri ATCC PTA 4659 in Ulcerative Colitis | The Effect of Lactobacillus Reuteri ATCC PTA 4659 in Patients With Ulcerative Colitis | Ulcerative Colitis Flare | Dietary Supplement: Lactobacillus reuteri;Dietary Supplement: Placebo | Uppsala University | Recruiting | 18 Years | 80 Years | All | 40 | Phase 2 | Sweden | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 231 | NCT02862132 | January 2017 | 28 January 2019 | Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases | Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases (IBD) Including Drug Levels: a Multi-center Prospective Cohort Study, From the Pediatric IBD Porto Group of European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) | Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease | Drug: Vedolizumab | Shaare Zedek Medical Center | Recruiting | N/A | 18 Years | All | 120 | N/A | United States;Denmark;Finland;Ireland;Israel;Slovenia;United Kingdom | |
| 232 | NCT02878083 | January 2017 | 11 June 2018 | Development of a Biomarker of Efficacy of Vedolizumab (EnTyvio®) in Patients With ulcErative ColiTis (DETECT) | Development of a Biomarker of Efficacy of Vedolizumab (EnTyvio®) in Patients With ulcErative ColiTis (DETECT) | ULCERATIVE COLITIS | Drug: VEDOLIZUMAB;Drug: ADALIMUMAB | Nantes University Hospital | Takeda;Mauna Kea Technologies;Institut national de la santé et de la recherche médicale unité U1235 FRANCE;Institut national de la santé et de la recherche médicale unité1064 FRANCE | Recruiting | 18 Years | N/A | All | 25 | N/A | France |
| 233 | EUCTR2017-000573-37-IE | 13 November 2017 | Research study to determine whether an investigational drug, SHP647, is safe and effective in the treatment of moderate to severe Ulcerative Colitis, compared with placebo (dummy treatment) – using a randomised and blinded study design (investigator and patients are not aware whether they receive study drug or placebo)(FIGARO UC 303). | A Phase 3 Randomized, Double-blind, Placebo controlled, Parallel group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Ulcerative Colitis (FIGARO UC 303) - FIGARO UC 303 | Ulcerative colitis MedDRA version: 20.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use Product Code: SHP647 Pharmaceutical Form: Solution for injection INN or Proposed INN: Anti-MAdCAM antibody Current Sponsor code: SHP647 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Shire Human Genetic Therapies, Inc. | Not Available | Female: yes Male: yes | 772 | Phase 3 | Serbia;Portugal;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Colombia;Switzerland;Italy;France;Australia;South Africa;Netherlands;Japan;New Zealand;Germany;Bulgaria;Croatia;Romania;Brazil;Belgium;Poland;Argentina;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Austria;Lithuania;Bosnia and Herzegovina;Korea, Republic of | ||||
| 234 | EUCTR2017-003649-10-PL | 28 February 2019 | A Pharmacokinetic, Pharmacodynamic, and Safety Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients From 4 Years to Less Than 18 Years of Age with Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn’s Disease | A PHASE I, OPEN–LABEL, RANDOMIZED, PHARMACOKINETIC, PHARMACODYNAMIC, AND SAFETY STUDY OF ETROLIZUMAB FOLLOWED BY OPEN–LABEL EXTENSION AND SAFETY MONITORING IN PEDIATRIC PATIENTS FROM 4 YEARS TO LESS THAN 18 YEARS OF AGE WITH MODERATE TO SEVERE ULCERATIVE COLITIS OR MODERATE TO SEVERE CROHN’S DISEASE | Moderate to severe ulcerative colitis (UC); moderate to severe Crohn’s disease (CD) MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: 549-0261/F02-01 Pharmaceutical Form: Solution for injection INN or Proposed INN: ETROLIZUMAB CAS Number: 1044758-60-2 Current Sponsor code: RO5490261/F02-01 Other descriptive name: ETROLIZUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- | F. Hoffmann-La Roche Ltd | Not Available | Female: yes Male: yes | 60 | Phase 1 | United States;Belgium;Spain;Poland;Germany;United Kingdom | ||||
| 235 | JPRN-UMIN000024520 | 2016/12/15 | 2 April 2019 | Exploratory study of antibiotics combination therapy for moderate to severe ulcerative colitis | ulcerative colitis | placebo metronidazole metronidazole,amoxicillin metronidazole,amoxicillin,tetracycline | Hokkaido University Hospital | Not Recruiting | 16years-old | 80years-old | Male and Female | 212 | Not selected | Japan | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 236 | NCT03101800 | December 14, 2016 | 27 August 2018 | Beneficial and Harmful Effects of Azathioprine and Allopurinol Versus Standard Azathioprine Therapy for Patients With Ulcerative Colitis | Low-dose Azathioprine and Allopurinol- Versus Azathioprine Monotherapy in Patients With Ulcerative Colitis: An Investigator-initiated, Open, Multicentre, Parallel-arm, Randomised Controlled Trial | Colitis, Ulcerative;Colitis Ulcerative Exacerbation | Drug: Azathioprine and Allopurinol;Drug: Azathioprine | Hvidovre University Hospital | Aalborg Universitetshospital;Zealand University Hospital;University of Copenhagen;Odense University Hospital;Aarhus University Hospital;Regional Hospital Viborg;Vejle Hospital;Sydvestjysk Hospital Esbjerg | Recruiting | 18 Years | 80 Years | All | 84 | Phase 3 | Denmark |
| 237 | EUCTR2016-001684-36-SK | 12/12/2016 | 21 August 2017 | EFFICACY AND SAFETY STUDY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF PATIENTS WITH ACTIVE ULCERATIVE COLITIS | A PHASE 2, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GED-0507-34-LEVO (GED0507) FOR TREATMENT OF SUBJECTS WITH ACTIVE ULCERATIVE COLITIS | Ulcerative Colitis MedDRA version: 20.0 Level: LLT Classification code 10021184 Term: IBD System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: LLT Classification code 10045366 Term: Ulcerative colitis, unspecified System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GED-0507-34-Levo Product Code: GED0507 Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: (S)-(-)-3-(4-Aminophenyl)-2-methoxypropionic Acid Current Sponsor code: GED-0507-34-Levo Other descriptive name: GED-0507-34-LEVO Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80- Pharmaceutical form of the placebo: Gastro-resistant tablet Route of administration of the placebo: Oral use | PPM SERVICES SA | Not Recruiting | Female: yes Male: yes | 207 | Phase 2 | France;United States;Hungary;Slovakia;Canada;Poland;Spain;Ukraine;Bulgaria;Latvia;Italy;United Kingdom | |||
| 238 | EUCTR2016-001409-18-NO | 06/12/2016 | 12 December 2016 | A study to evaluate the safety of stopping versus continuing anti TNF therapy in ulcerative colitis patients in remission, and to evaluate the safety and efficacy of restarting anti TNF therapy in patients with disease recurrence | A prospective, open randomized, parallel-group study to evaluate the outcome of discontinuing or continuing anti-tumor necrosis factor treatment in patients with ulcerative colitis in sustained clinical remission. - The Biostop study | Ulcerative colitis MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: 1.Remicade INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 5-10 Trade Name: Humira Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Trade Name: Simponi Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: GOLIMUMAB CAS Number: 476181-74-5 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 100- | Helse More og Romsdal Hospital Trust | Authorised | Female: yes Male: yes | Phase 4 | Norway | ||||
| 239 | NCT02425852 | December 2016 | 11 February 2019 | A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis | A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus Infliximab to Corticosteroids Plus Azathioprine for Acute Severe Colitis | Ulcerative Colitis | Drug: Azathioprine;Drug: Infliximab;Drug: Prednisolone;Drug: Hydrocortisone | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Recruiting | 18 Years | N/A | All | 146 | Phase 4 | France | |
| 240 | NCT02425865 | December 2016 | 3 June 2019 | Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis - In-TARGET | Intensive Treatment to Reach the Target With Golimumab in ulcErative coliTis- In-TARGET | ULCERATIVE COLITIS | Drug: GOLIMUMAB | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Recruiting | 18 Years | 75 Years | All | 200 | Phase 4 | Belgium;France | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 241 | NCT02895100 | December 2016 | 18 March 2019 | Safety and Efficacy Study of PTG-100 in the Treatment of Moderate to Severe Ulcerative Colitis | A Phase 2b Randomised, Double-blind, Placebo-controlled, Parallel, Adaptive 2-Stage, Multi-Centre Study to Evaluate the Safety and Efficacy of Oral PTG-100 Induction in Subjects With Moderate to Severe Active Ulcerative Colitis | Ulcerative Colitis | Drug: PTG-100;Drug: Placebo | Protagonist Therapeutics | Not recruiting | 18 Years | 80 Years | All | 100 | Phase 2 | United States;Australia;Belgium;Bosnia and Herzegovina;Canada;Croatia;Czechia;Germany;Hungary;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Russian Federation;Serbia;Ukraine | |
| 242 | NCT02985593 | December 2016 | 11 June 2018 | A Phase 1 Study of KHK4083 in Healthy Volunteers and Subjects With Ulcerative Colitis | A Phase 1, Single-Blind, Randomized, Placebo-Controlled, Single-Dose or Open-Label Multiple-Dose Study of KHK4083 in Healthy Adults and Subjects With Ulcerative Colitis | Healthy Men and Subjects With Ulcerative Colitis | Drug: KHK4083;Drug: Placebo | Kyowa Hakko Kirin Co., Ltd | Not recruiting | 20 Years | N/A | All | 155 | Phase 1 | Japan | |
| 243 | NCT02998112 | December 2016 | 9 January 2017 | Fecal Microbiota Transplantation for Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing | Ulcerative Colitis | Drug: fecal microbiota transplantation;Drug: Saline | The Second Hospital of Nanjing Medical University | Fourth Military Medical University;First Hospital of Guangzhou;Daping Hospital and the Research Institute of Surgery of the Third Military Medical University;Zhongshan Hospital Xiamen University | Recruiting | 18 Years | 65 Years | Both | 188 | Phase 4 | China | |
| 244 | JPRN-UMIN000024936 | 2016/11/30 | 2 April 2019 | Efficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitis | Ulcerative colitis | patients who received Infliximab continued to treat every 8 week and who received Adalimumab continued to treat every 2 week. Patients received Tacrolimus 0.5mg2Cap par day at day0. Day0 is day of first anti TNF-alfa antibody treat after participate this study. We control Tacrolimus trough levels 3 to 5 mg/ml. | Keio University Gastroenterology and Hepatology | Recruiting | 16years-old | 150years-old | Male and Female | 30 | Not selected | Japan | ||
| 245 | NCT02808390 | November 28, 2016 | 16 December 2017 | Efficacy and Safety Study of GED-0507-34-Levo for Treatment of UC | A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of GED-0507-34-Levo (GED0507) for Treatment of Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Drug: GED-0507-34-Levo 80 mg;Drug: GED-0507-34-Levo 160 mg;Drug: Placebo | PPM Services S.A. | Not recruiting | 18 Years | N/A | All | 19 | Phase 2 | United States;Bulgaria;Canada;France;Hungary;Italy;Latvia;Poland;Slovakia;Ukraine | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 246 | NCT02903966 | November 15, 2016 | 26 August 2019 | GSK2982772 Study in Subjects With Ulcerative Colitis | A Multicentre, Randomised, Double-blind (Sponsor Unblinded), Placebo-controlled Study With Open Label Extension to Investigate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of GSK2982772 in Subjects With Active Ulcerative Colitis | Colitis, Ulcerative | Drug: GSK2982772;Drug: Placebo | GlaxoSmithKline | Not recruiting | 18 Years | 75 Years | All | 36 | Phase 2 | United States;Germany;Netherlands;Poland;Russian Federation;Sweden;United Kingdom | |
| 247 | NCT02914522 | November 14, 2016 | 26 August 2019 | Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis | Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Filgotinib;Drug: Placebo to match filgotinib | Gilead Sciences | Galapagos NV | Not recruiting | 18 Years | 75 Years | All | 1351 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;France;Georgia;Germany;Greece;Hong Kong;Hungary;India;Ireland;Israel;Italy;Japan;Korea, Republic of;Malaysia;Mexico;Netherlands;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Ukraine;United Kingdom;Iceland |
| 248 | NCT02760615 | November 1, 2016 | 10 December 2018 | Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study | An Open-Label, 2-Part, Multicenter, Post-marketing Study to Evaluate the Effect of Moderately or Severely Active Ulcerative Colitis or Crohn's Disease on Cytochrome P-450 Enzyme Substrates Compared to Healthy Subjects and the Effect of Vedolizumab Treatment on Cytochrome P-450 Enzyme Substrates in Subjects With Ulcerative Colitis or Crohn's Disease | Colitis, Ulcerative;Crohn Disease | Drug: Caffeine;Drug: Losartan;Drug: Omeprazole;Drug: Dextromethorphan;Drug: Midazolam;Drug: Vedolizumab | Takeda | Recruiting | 18 Years | 55 Years | All | 60 | Phase 4 | United States | |
| 249 | NCT02291523 | November 2016 | 11 February 2019 | The Effect of Therapeutic Fecal Transplant on the Gut Microbiome in Children With Ulcerative Colitis | The Effect of Therapeutic Fecal Transplant on the Gut Microbiome in Children With Ulcerative Colitis | Ulcerative Colitis | Biological: Fecal Microbial Transplant | Children's Hospital Los Angeles | Recruiting | 7 Years | 21 Years | All | 101 | Phase 1 | United States | |
| 250 | NCT02962245 | November 2016 | 21 November 2016 | Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis | Efficacy of Treatment With Berberine to Maintain Remission in Ulcerative Colitis: An Open-label,Randomized,Phase IV Clinical Trial | Ulcerative Colitis | Drug: berberine;Drug: regular treatment | Xijing Hospital of Digestive Diseases | Not recruiting | 18 Years | 70 Years | Both | 238 | Phase 4 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 251 | NCT03136419 | October 31, 2016 | 16 December 2017 | Microbiota and Immune microEnvironment in Pouchitis | Microbiota and Immune microEnvironment in Pouchitis: Randomized Controlled Trial Oral Administration of Lactobacillus Casei DG After Ileostomy Closure in Ileal Pouch Mucosa | Pouchitis;Ulcerative Colitis;Ileal Pouch | Dietary Supplement: Lactobacillus casei DG;Dietary Supplement: Placebo | University of Padova | Recruiting | 18 Years | 100 Years | All | 32 | N/A | Italy | |
| 252 | EUCTR2016-000509-35-BG | 27/10/2016 | 30 April 2018 | Drug OPRX-106 in Patients with Ulcerative Colitis | An Open Label, Proof of Concept Study to Assess the Safety, PK and Explore Efficacy of OPRX-106 in Patients with Active Mild to Moderate Ulcerative Colitis | Active mild to moderate ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: OPRX-106 (plant cells expressing TNFR-Fc) 8mg Product Code: OPRX-106 Pharmaceutical Form: Powder for oral suspension Product Name: OPRX-106 (plant cells expressing TNFR-Fc) 2mg Product Code: OPRX-106 Pharmaceutical Form: Powder for oral suspension | Protalix Biotherapeutics Ltd. | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Serbia;Israel;Bulgaria | |||
| 253 | NCT02840721 | October 26, 2016 | 11 March 2019 | Safety, Efficacy, and Tolerability Study of PF-06480605 in Subjects With Moderate to Severe Ulcerative Colitis. | A PHASE 2A, MULTICENTER, SINGLE ARM, OPEN- LABEL, TWO-STAGE, STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06480605 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Colitis, Ulcerative | Drug: PF-06480605 | Pfizer | Not recruiting | 18 Years | 75 Years | All | 50 | Phase 2 | United States;Belgium;Italy;Korea, Republic of;Netherlands;Poland;France | |
| 254 | EUCTR2015-005260-41-NL | 13/10/2016 | 31 October 2016 | Efficacy of optimized thiopurine therapy in ulcerative colitis. | Efficacy of optimized thiopurine therapy in ulcerative colitis. - OPTIC | Ulcerative Colitis MedDRA version: 19.0 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mercaptopurine (Puri-Nethol) Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Academic Medical Centre | Authorised | Female: yes Male: yes | Phase 3 | Netherlands | ||||
| 255 | EUCTR2016-002061-54-IT | 13/10/2016 | 7 January 2019 | Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases. | Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) in the treatment of rheumatoid arthritis, spondyloarthritis and chronic inflammatory bowel diseases. Evaluation of immunogenicity and clinical response - Switch between originator infliximab (Remicade®) and biosimilar infliximab (Remsima®) | Rheumatoid arthritis, seronegative spondylo arthritis, Crohn's Disease, Ulcerative Colitis MedDRA version: 20.0 Level: PT Classification code 10002556 Term: Ankylosing spondylitis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.0 Level: PT Classification code 10075634 Term: Acute haemorrhagic ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: REMSIMA - 100 MG POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLANCONCINO (VETRO) - 1 FLACONCINO Product Name: Remsima Product Code: 42942019 Pharmaceutical Form: Powder for solution for infusion | UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Italy | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 256 | EUCTR2016-000420-26-CZ | 06/10/2016 | 26 November 2018 | A study to test the effectiveness of bimekizumab as a treatment for ulcerative colitis to look for unwanted side effects and to measure how the drug is distributed, modified and cleared from the body. | A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS | SEVERE ACTIVE ULCERATIVE COLITIS MedDRA version: 20.0 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Bimekizumab Product Code: UCB4940 Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Bimekizumab CAS Number: 1418205-77-2 Current Sponsor code: CDP4940 Other descriptive name: UCB4940 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 160- Pharmaceutical form of the placebo: Solution for injection/infusion Route of administration of the placebo: Intravenous use | UCB Biopharma SPRL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | France;Czech Republic;Poland;Spain;Romania;Bulgaria;Georgia;South Africa;Moldova, Republic of;Italy;United Kingdom | |||
| 257 | NCT02516384 | October 1, 2016 | 5 March 2018 | Fecal Microbiota Transplantation (FMT) in the Management of Ulcerative Colitis (UC) | Fecal Microbiota Transplantation (FMT) in the Management of Ulcerative Colitis (UC) | Ulcerative Colitis | Biological: Fecal Microbiota Transplantation | Weill Medical College of Cornell University | Not recruiting | 18 Years | N/A | All | 20 | Phase 1 | United States | |
| 258 | NCT03018925 | October 2016 | 16 December 2017 | Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis | Golimumab Effect in the Modulation of Gut Microbiota in Ulcerative Colitis: Pilot Study | Ulcerative Colitis | Drug: Golimumab | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta | Recruiting | 18 Years | N/A | All | 15 | N/A | Spain | |
| 259 | EUCTR2016-003073-18-GB | 29/09/2016 | 3 April 2017 | A study designed to investigate how radiolabelled RPC1063 is taken up, broken down and removed from the body | A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686) | The drug is a potential treatment for adult patients with relapsing multiple sclerosis (RMS) and for adult patients with moderately to severely active inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn’s disease (CD). MedDRA version: 19.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 MedDRA version: 19.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: [14C]-RPC1063 Solution (0.1 mg/mL) for Oral Administration Pharmaceutical Form: Oral solution INN or Proposed INN: Ozanimod hydrochloride CAS Number: 1618636-37-5 Current Sponsor code: RPC1063HCL Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.1- | Celgene International II Sàrl | Authorised | Female: no Male: yes | 6 | Phase 1 | United Kingdom | |||
| 260 | NCT02819635 | September 26, 2016 | 22 October 2019 | A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis (UC) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) | Drug: Placebo;Drug: Updacitinib (ABT-494) | AbbVie | Recruiting | 16 Years | 75 Years | All | 844 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Canada;Chile;China;Colombia;Croatia;Czechia;Egypt;Estonia;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Norway;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;Ukraine;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 261 | EUCTR2016-001158-16-PL | 23/09/2016 | 10 December 2018 | Study to test whether PF-06480605 is safe and improves symptoms in patients with ulcerative colitis | A PHASE 2A, MULTICENTER, SINGLE ARM, OPEN-LABEL, TWO-STAGE, STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06480605 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis (UC) MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: PF-06480605 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: PF-06480605 Current Sponsor code: PF-06480605 Other descriptive name: PF-06480605 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 42.5-57.5 | Pfizer Inc. 235 East 42nd Street, New York, NY 10017 | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | France;United States;Belgium;Poland;Netherlands;Italy;Korea, Republic of | |||
| 262 | EUCTR2014-004904-31-BE | 21/09/2016 | 20 August 2018 | A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remsima (infliximab) Pharmaceutical Form: Powder for concentrate for solution for injection/infusion | Mundipharma Pharmaceuticals B.V. | Not Recruiting | Female: yes Male: yes | 156 | Phase 4 | Belgium;Netherlands | |||
| 263 | EUCTR2016-000641-31-SK | 20/09/2016 | 23 January 2017 | Efficacy and Safety of ABT-494 in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis MedDRA version: 19.1 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ABT-494 Pharmaceutical Form: Tablet INN or Proposed INN: ABT-494 CAS Number: 1310726-60-3 Other descriptive name: ABT-494 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 7.5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: ABT-494 Pharmaceutical Form: Tablet INN or Proposed INN: ABT-494 CAS Number: 1310726-60-3 Other descriptive name: ABT-494 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: ABT-494 Pharmaceutical Form: Tablet INN or Proposed INN: ABT-494 CAS Number: 1310726-60-3 Other descriptive name: ABT-494 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | AbbVie Deutschland GmbH & Co. KG | Authorised | Female: yes Male: yes | 1055 | Phase 2;Phase 3 | Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Austria;Egypt;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Singapore;Kazakhstan;Norway;Japan;New Zealand | |||
| 264 | EUCTR2016-000674-38-SK | 20/09/2016 | 1 October 2018 | Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis. | A Phase 3 Multicenter, Long-Term Extension Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) in Subjects with Ulcerative Colitis (UC) | Ulcerative Colitis MedDRA version: 20.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Upadacitinib Product Code: ABT-494 Pharmaceutical Form: Tablet INN or Proposed INN: Upadacitinib CAS Number: 1310726-60-3 Current Sponsor code: ABT-494 Other descriptive name: ABT-494 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: Upadacitinib Product Code: ABT-494 Pharmaceutical Form: Tablet INN or Proposed INN: Upadacitinib CAS Number: 1310726-60-3 Current Sponsor code: ABT-494 Other descriptive name: ABT-494 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: Upadacitinib Product Code: ABT-494 Pharmaceutical Form: Tablet INN or Proposed INN: Upadacitinib CAS Number: 1310726-60-3 Current Sponsor code: ABT-494 Other descriptive name: ABT-494 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 7.5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | AbbVie Deutschland GmbH & Co. KG | Authorised | Female: yes Male: yes | 950 | Phase 3 | Portugal;Serbia;Belarus;United States;Estonia;Saudi Arabia;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Switzerland;Puerto Rico;Malaysia;Australia;South Africa;Latvia;Netherlands;China;Bosnia and Herzegovina;Korea, Republic of;Finland;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;European Union;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Singapore;Croatia;Kazakhstan;Norway;Japan;New Zealand;Sweden | |||
| 265 | NCT02864264 | September 14, 2016 | 16 December 2017 | Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative Colitis | Double-Blind, Randomized, Placebo-Controlled, Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Target Engagement of BMS-986184 in Healthy Subjects and to Evaluate the Safety, Efficacy, Pharmacokinetics, Target Engagement, and Pharmacodynamics of BMS-986184 in Patients With Moderate to Severe Ulcerative Colitis | Healthy Volunteers;Ulcerative Colitis | Drug: BMS-986184;Drug: Placebo matching BMS-986184 | Bristol-Myers Squibb | Not recruiting | 18 Years | 75 Years | All | 7 | Phase 1 | Australia;Georgia;Moldova, Republic of;Romania | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 266 | NCT02883452 | September 12, 2016 | 26 August 2019 | A Phase I Study to Evaluate PK, Efficacy and Safety of CT-P13 SC in Patients With Active CD and UC | An Open-label, Randomized, Parallel-Group, Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Crohn's Disease and Active Ulcerative Colitis | Crohn's Disease;Ulcerative Colitis | Biological: Infliximab | Celltrion | Not recruiting | 18 Years | 75 Years | All | 170 | Phase 1 | Korea, Republic of | |
| 267 | EUCTR2016-001833-29-SE | 07/09/2016 | 19 March 2018 | A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis | A multicentre, randomised, double-blind (sponsor-unblinded), placebo-controlled study with open label extension to investigate the safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of GSK2982772 in subjects with active ulcerative colitis. | Active ulcerative colitis MedDRA version: 20.0 Level: HLGT Classification code 10017969 Term: Gastrointestinal inflammatory conditions System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: GSK2982772 Product Code: GSK2982772 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Not Available CAS Number: Not Availabl Current Sponsor code: GSK2982772 Other descriptive name: GSK2982772A, where A denotes the free base Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | GlaxoSmithKline Research & Development Ltd | Authorised | Female: yes Male: yes | 48 | Phase 2 | Poland;Netherlands;Germany;United Kingdom;Sweden | |||
| 268 | JPRN-UMIN000022588 | 2016/09/01 | 2 April 2019 | Assessment of indication and efficacy of anti-viral therapy based on mucosal PCR assay in active UC patients with CMV infection. | Ulcerative colitis | Additional immunosuppressive therapies combined with anti-viral therapy (Ganciclovir 5mg/kg, twice a day, 2weeks) Additional immunosuppressive therapies without administration of ganciclovir | Department of Gastroenterology and Hepatology, Kyoto University Hospital | Not Recruiting | 20years-old | Not applicable | Male and Female | 120 | Not applicable | Japan | ||
| 269 | NCT02825914 | September 1, 2016 | 7 October 2019 | CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM) | CAsein GLycomacropeptide in Ulcerative Colitis - Anti-Inflammatory and Microbiome Modulating Effects (CAGLUCIM) | Colitis, Ulcerative;Inflammatory Bowel Diseases | Dietary Supplement: Casein glycomacropeptide (CGMP);Dietary Supplement: Placebo | University of Aarhus | Not recruiting | 18 Years | N/A | All | 80 | N/A | Denmark | |
| 270 | NCT02764229 | September 2016 | 11 June 2018 | Open-label Extension Study to Assess Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis | A Multicenter Open-label Extension Study to Assess the Safety and Tolerability of LYC-30937-EC in Subjects With Active Ulcerative Colitis | Colitis, Ulcerative | Drug: LYC-30937-EC | Lycera Corp. | Not recruiting | 18 Years | 75 Years | All | 120 | Phase 2 | United States;Czechia;Hungary;Netherlands;Poland;Serbia | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 271 | NCT02768974 | September 2016 | 10 October 2016 | Open Label Study to Assess Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis | An Open Label, Proof of Concept Study to Assess the Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: OPRX-106 | Protalix | Recruiting | 18 Years | 70 Years | Both | 20 | Phase 2 | Israel | |
| 272 | NCT02888379 | September 2016 | 16 December 2017 | Phase 2a Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Ulcerative Colitis | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients With Moderate to Severe Disease Activity | Ulcerative Colitis | Drug: TOP1288;Drug: Placebo (for TOP1288) | Topivert Pharma Ltd | Not recruiting | 18 Years | 75 Years | All | 77 | Phase 2 | Bulgaria;Czechia;Hungary;Latvia;Lithuania;Poland;Ukraine;United Kingdom;Czech Republic | |
| 273 | EUCTR2016-002433-30-DK | 25/08/2016 | 7 January 2019 | Effect of azathioprine and allopurinol compared to azaothioprine monotherapy in ulcerative colitis | Low-dose azathioprine and allopurinol versus azathioprine monotherapy for patients with ulcerative colitis: protocol for an investigator initiated, open, multicentre, parallel arm, randomised controlled trial - AAUC | Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Imurel Pharmaceutical Form: Tablet INN or Proposed INN: Azathioprine CAS Number: 446-86-6 Other descriptive name: AZATHIOPRINE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 25-50 Trade Name: Allopurinol Pharmaceutical Form: Tablet INN or Proposed INN: ALLOPURINOL CAS Number: 315-30-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Hvidovre Hospital | Authorised | Female: yes Male: yes | 84 | Phase 3 | Denmark | |||
| 274 | EUCTR2015-001346-29-BE | 22/08/2016 | 17 October 2016 | A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | Ulcerative Colitis MedDRA version: 18.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 Pharmaceutical Form: Injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Current Sponsor code: Humira Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- | AbbVie Deutschland GmbH & Co. KG | Authorised | Female: yes Male: yes | 93 | Phase 3 | United States;Hungary;Canada;Spain;Belgium;Australia;Israel;United Kingdom;New Zealand;Japan | |||
| 275 | JPRN-UMIN000026485 | 2016/08/01 | 2 April 2019 | Research on the Efficacy of Fecal Microbiota Transplantation and Microbiota in Japanese Children with Ulcerative Colitis. | ulcerative colitis | Fecal Microbiota Transplantation(on Day1, 2 and 3, week 2, 3 and 5) after antibiotic pretreatment using amoxicillin 40mg/kg/day, fosfomycin 100mg/kg/day and metronidazole 16mg/kg/day. | National Center for Child Health and Development | 10Probiotics Research Laboratory, Juntendo University Graduate School of Medicine, Tokyo, Japan. Yakult Central Institute, Tokyo, Japan | Recruiting | 2years-old | 18years-old | Male and Female | 12 | Not selected | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 276 | NCT02743806 | August 1, 2016 | 11 November 2019 | Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease | Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn's Disease | Colitis, Ulcerative;Crohn Disease | Drug: Vedolizumab | Takeda | Not recruiting | 18 Years | 90 Years | All | 331 | Phase 4 | Australia;Bulgaria;Czechia;Estonia;Hungary;India;Italy;Korea, Republic of;Latvia;Malaysia;New Zealand;Poland;Romania;Russian Federation;Serbia;South Africa;Turkey;Ukraine;Czech Republic;Slovakia;Taiwan | |
| 277 | NCT02818686 | August 2016 | 20 August 2018 | TD-1473 for Active Ulcerative Colitis (UC) | A Phase 1b Multi-Center, Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Plasma Exposure of TD-1473 in Subjects With Moderately-to-Severely Active Ulcerative Colitis | Ulcerative Colitis, Active Moderate;Ulcerative Colitis, Active Severe | Drug: TD-1473;Drug: Placebo | Theravance Biopharma R & D, Inc. | Not recruiting | 18 Years | 75 Years | All | 40 | Phase 1 | United States | |
| 278 | NCT02865707 | August 2016 | 3 June 2019 | Ulcerative Colitis Relapse Prevention by Prebiotics | Prevention of Ulcerative Colitis by Prebiotics: Efficacy and Protective Mechanisms | Ulcerative Colitis | Dietary Supplement: Synergy-1;Dietary Supplement: Maltodextrin | University of Alberta | University of British Columbia | Recruiting | 18 Years | 75 Years | All | 100 | N/A | Canada |
| 279 | EUCTR2016-000235-40-SE | 29/07/2016 | 8 August 2016 | Stopping anti-TNF treatment in Crohn’s and Colitis patients in remission | Stopping anti-TNF treatment in Crohn’s and Colitis patients in remission - The StatiC study | Crohn´s disease Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: Remsima Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: Inflectra Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: Humira Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- | Region Skåne | Authorised | Female: yes Male: yes | Phase 4 | Sweden | ||||
| 280 | EUCTR2016-000205-36-DE | 11/07/2016 | 14 November 2016 | A Clinical Trial to Evaluate Activity, Safety and Tolerability of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD). | A Single-Centre, Exploratory Trial to Assess the Mechanisms of Molecular Activity, Safety and Tolerability of One Dose Level of FE 999301 by Intravenous Infusions in Patients with Active Inflammatory Bowel Disease (IBD) - FUTURE | Inflammatory Bowel Disease (Crohn`s Disease and Ulcerative Colitis) MedDRA version: 19.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: FE 999301 Pharmaceutical Form: Concentrate for solution for infusion | University Hospital Schleswig-Holstein (UKSH) | Authorised | Female: yes Male: yes | Phase 2 | Germany | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 281 | JPRN-UMIN000019958 | 2016/07/02 | 2 April 2019 | Research for biomarkers of inflammatory bowel disease. - Investigation of the usefulness of LRG for evaluation of disease condition after adalimumab treatments | Crohn's disease, ulcerative colitis | Patients with Crohn's disease or ulcerative colitis Adalimumab administration subcutaneously for 52 weeks using the recommended dosing regimens. | Iwate Medical University Kochi Medical School Hospital Keio University School of Medicine | Not Recruiting | 15years-old | Not applicable | Male and Female | 100 | Not applicable | Japan | ||
| 282 | NCT02762500 | July 2016 | 25 June 2018 | An Efficacy and Safety Study of LYC-30937-EC in Subjects With Active Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled Parallel Group Study to Assess the Efficacy and Safety of Induction Therapy With LYC-30937-EC in Subjects With Active Ulcerative Colitis | Colitis, Ulcerative | Drug: LYC-30937-EC;Drug: Placebo | Lycera Corp. | Not recruiting | 18 Years | 75 Years | All | 124 | Phase 2 | United States;Canada;Czechia;Hungary;Netherlands;Poland;Serbia;Czech Republic | |
| 283 | NCT02770040 | July 2016 | 21 July 2016 | Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis | PREDICT UC: Optimising Infliximab Induction Therapy for Acute Severe Ulcerative Colitis - A Randomised Controlled Trial | Ulcerative Colitis | Drug: Infliximab | Austin Health | University of Melbourne | Recruiting | 18 Years | 80 Years | Both | 138 | Phase 4 | Australia |
| 284 | NCT02849951 | July 2016 | 16 December 2017 | A Study to Investigate the Safety and Efficacy of LT-02 in Patients With Mesalamine Refractory Ulcerative Colitis (UC) | A Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of a 12-week Add-on Treatment With LT-02 vs. Placebo in Subjects With Ulcerative Colitis Refractory to Standard Treatment With Mesalamine | Ulcerative Colitis | Drug: LT-02;Drug: LT-02 Placebo | Prometheus Laboratories | Nestlé Health Science Spain;INC Research | Not recruiting | 18 Years | 70 Years | All | 25 | Phase 3 | United States |
| 285 | EUCTR2016-000678-40-CZ | 27/06/2016 | 28 February 2019 | Program to allow continuation of treatment with Entyvio (Vedolizumab IV) for patients with ulcerative colitis and Chron´s disease who previously participated in a clinical trial with this same treatment | Entyvio (Vedolizumab IV) Extended Access Program in Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 MedDRA version: 20.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Product Name: vedolizumab IV Product Code: MLN002 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: vedolizumab CAS Number: 943609-66-3 Current Sponsor code: MLN0002 Other descriptive name: VEDOLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- | Takeda Development Centre Europe Limited | Authorised | Female: yes Male: yes | 385 | Phase 4 | Serbia;Taiwan;Estonia;Slovakia;Ukraine;Turkey;Russian Federation;Italy;India;Czech Republic;Hungary;Poland;Malaysia;Romania;Australia;South Africa;Bulgaria;Latvia;New Zealand;Korea, Republic of | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 286 | NCT02365480 | June 16, 2016 | 22 October 2019 | Berberine Chloride in Preventing Colorectal Cancer in Patients With Ulcerative Colitis in Remission | Phase I Trial of Berberine in Subjects With Ulcerative Colitis | Ulcerative Colitis | Drug: Berberine Chloride;Other: Laboratory Biomarker Analysis;Other: Placebo | National Cancer Institute (NCI) | Not recruiting | 18 Years | 70 Years | All | 18 | Phase 1 | United States;China | |
| 287 | NCT02665845 | June 13, 2016 | 4 November 2019 | Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone (for Ulcerative Colitis). | Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis: A Protocol of a Multi-center Prospective Randomized Investigator Blinded Trial. | Ulcerative Colitis | Drug: 5-ASA;Drug: Corticosteroids | Centre Hospitalier Universitaire de Saint Etienne | Recruiting | 18 Years | N/A | All | 160 | Phase 3 | France;Greece;Israel;Italy;Korea, Republic of;Serbia | |
| 288 | EUCTR2016-000390-20-GB | 10/06/2016 | 23 January 2017 | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity | A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety/Tolerability and Efficacy of TOP1288 200 mg Rectal Solution Once Daily for 4 Weeks in Symptomatic Ulcerative Colitis Patients with Moderate to Severe Disease Activity | Symptomatic Ulcerative Colitis Patients with Moderate Disease Activity MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: TOP1288 Rectal solution Pharmaceutical Form: Rectal solution INN or Proposed INN: Not Applied for CAS Number: 1630202-02-6 Current Sponsor code: TOP1288 Other descriptive name: TOP1288 rectal solution Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Rectal solution Route of administration of the placebo: Rectal use | TOPIVERT Pharma Limited | Authorised | Female: yes Male: yes | 60 | Phase 2 | Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia;United Kingdom | |||
| 289 | EUCTR2016-001278-13-FI | 08/06/2016 | 27 June 2016 | Immunologic, genetic and bowel microbes as predictors of the treatment response for TNFalpha-blocking drugs in patients with Crohn’s disease or ulcerative colitis | Immunologic, genetic and microbiomic predictors of the treatment response for TNFalpha-blocking drugs – prospective follow-up cohort of patients with Crohn’s disease or ulcerative colitis - PROSIBD | Ulcerative colitis and Crohn's disease MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: LLT Classification code 10058815 Term: Crohn's disease acute episode System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: LLT Classification code 10057035 Term: Crohn's ileocolitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: LLT Classification code 10011405 Term: Crohn's enteritis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: LLT Classification code 10011406 Term: Crohn's ileitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: LLT Classification code 10076318 Term: Crohn's disease relapse System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: LLT Classification code 10011402 Term: Crohn's disease (colon) System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: LLT Classification code 10075466 Term: Fistulising Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: LLT Classification code 10075465 Term: Fistulizing Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 19.0 Level: LLT Classification code 10011400 Term: Crohn's colitis System Organ Class: 10017947 - Gastrointe;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima Product Name: Remsima Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 | Taina Sipponen | Authorised | Female: yes Male: yes | Phase 4 | Finland | ||||
| 290 | NCT02687724 | June 2016 | 20 August 2018 | Golimumab (GLM) Dose Optimisation to Adequate Levels to Achieve Response in Colitis | GLM Dose Optimisation to Adequate Levels to Achieve Response in Colitis (GOAL-ARC). A Nationwide Multi-centred Randomised Controlled Trial (RCT) Investigating the Use of GLM Dose Adjustment in Ulcerative Colitis (UC). | Colitis | Drug: Golimumab (GLM) | University College Dublin | Recruiting | 18 Years | N/A | All | 136 | Phase 4 | Ireland | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 291 | NCT02606032 | May 2016 | 18 March 2019 | Trial of Antimicrobials Versus Placebo in Addition to Fecal Transplant Therapy in Ulcerative Colitis | Randomized Trial of Antimicrobials Versus Placebo in Addition to Fecal Microbiota Therapy in for the Induction of Remission in Active Ulcerative Colitis | Ulcerative Colitis | Drug: Metronidazole;Drug: Doxycycline;Drug: Terbinafine;Drug: Placebo | Hamilton Health Sciences Corporation | Hamilton Academic Health Sciences Organization | Recruiting | 18 Years | N/A | All | 80 | Phase 2 | Canada |
| 292 | EUCTR2015-004618-10-BE | 19/04/2016 | 8 August 2016 | PhArmaCo-kinetics of InFliximab during treatment Induction | Study of the inter-individual variation of PhArmaCo-kinetics of InFliximab during treatment Induction in patients with Crohn’s disease and Ulcerative Colitis | Patients with Crohn disease or Ulcerative Colitis which need biotherapy (antibody against TNF-a);Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remsima INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Other descriptive name: Remsima Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 5-10 Trade Name: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Other descriptive name: Remicade Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 5-10 Trade Name: Inflectra Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Other descriptive name: Inflectra Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 5-10 | CUB- Hopital Erasme | Authorised | Female: yes Male: yes | Phase 4 | Belgium | ||||
| 293 | NCT02620046 | April 15, 2016 | 20 May 2019 | Vedolizumab Subcutaneous Long-Term Open-Label Extension Study | A Phase 3b Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab Subcutaneous in Subjects With Ulcerative Colitis and Crohn's Disease | Colitis, Ulcerative;Crohn Disease | Drug: Vedolizumab SC | Takeda | Recruiting | 18 Years | 80 Years | All | 692 | Phase 3 | Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Taiwan;Turkey;Ukraine;United Kingdom;United States;Colombia;Czech Republic;Argentina;Australia;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland | |
| 294 | NCT02749630 | April 11, 2016 | 11 November 2019 | A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD) | An Observer-Blinded, Placebo-Controlled, Multiple-Ascending, Dose-Escalation Study to Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeat Intravenous Administrations of UTTR1147A in Healthy Volunteers and Patients With Ulcerative Colitis and Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Placebo;Drug: UTTR1147A | Genentech, Inc. | Not recruiting | 18 Years | 80 Years | All | 90 | Phase 1 | Germany;United Kingdom;Canada | |
| 295 | JPRN-UMIN000020029 | 2016/04/01 | 22 July 2019 | The significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infection | The significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infection - Monitoring by HBs antigen for HBV Reactivation | Collagen disease, collagen disease related disease, ulcerative colitis, Crohn's disease, intestinal Behcet's disease (simple ulcers included), psoriasis, and diseases that require other immunosuppressive therapies. | Entecavir administration is initiated when serum HBV-DNA levels increased up to 3.0 Log/IU/mL and/or serum HBs-antigen becomes detectable. | Saitama Medical University | Recruiting | 16years-old | Not applicable | Male and Female | 300 | Not selected | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 296 | EUCTR2015-002109-12-GB | 14/03/2016 | 28 February 2019 | A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease) | An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: APD334 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Not yet available Other descriptive name: APD334 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- | Arena Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Latvia;New Zealand | |||
| 297 | NCT02818543 | March 2016 | 9 January 2017 | Safety and Pharmacokinetic Study of LYC-30937 in Subjects With Active Ulcerative Colitis | An Open-Label, Single Ascending Dose Study To Evaluate The Pharmacokinetic Profile, Safety and Tolerability of Orally Administered LYC-30937 in Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Drug: LYC-30937 | Lycera Corp. | Not recruiting | 18 Years | 75 Years | Both | 6 | Phase 1 | Hungary | |
| 298 | EUCTR2015-003123-57-BE | 09/02/2016 | 7 May 2018 | An investigational study to assess the safety and effectiveness of an investigational drug in people with moderate to severe ulcerative colitis | A Phase 2, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Study of LY3074828 in Subjects with Moderate to Severe Ulcerative Colitis - AMAC | Ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mirikizumab Product Code: LY3074828 Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: Not assigned Current Sponsor code: LY3074828 Other descriptive name: LY3074828 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Solution for injection/infusion Route of administration of the placebo: Intravenous use | Eli Lilly and Company | Authorised | Female: yes Male: yes | 240 | Phase 2 | United States;Ukraine;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Denmark;Georgia;Netherlands;Moldova, Republic of;Japan | |||
| 299 | EUCTR2015-003364-36-HU | 09/02/2016 | 2 October 2017 | A study using a new drug (GED-0301) to investigate if the new drug works and is safe in subjects suffering ulcerative colitis. | A Phase 2, Open-label, Multicenter Study to Explore the Efficacy and Safety of Mongersen (GED-0301) in Subjects with Active Ulcerative Colitis. | Ulcerative Colitis. MedDRA version: 18.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mongersen Product Code: GED-0301 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Mongersen CAS Number: 1443994-86-6 Current Sponsor code: GED-0301 Other descriptive name: GED-0301 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- | Celgene Corporation | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Hungary;Slovakia;Canada;Poland;Bulgaria | |||
| 300 | EUCTR2015-001346-29-GB | 08/02/2016 | 9 October 2017 | A Multi-Center, Open-Label Study of Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects with Ulcerative Colitis Who Completed the Study M11-290 | Ulcerative Colitis MedDRA version: 20.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000016670 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: Adalimumab Product Code: 331731-18-1 Pharmaceutical Form: Injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Current Sponsor code: Humira Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- | AbbVie Deutschland GmbH & Co. KG | Not Recruiting | Female: yes Male: yes | 93 | Phase 3 | United States;Czech Republic;Hungary;European Union;Canada;Spain;Belgium;Israel;New Zealand;Japan;United Kingdom;Sweden | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 301 | JPRN-UMIN000020840 | 2016/02/02 | 2 April 2019 | A multi-Center, prospective study for maintenance of remission after discontinuation of adalimumab therapy in ulcerative colitis patients | ulcerative colitis | discontinuation of adalimumab therapy | Fukuyama Medical Center | Recruiting | 15years-old | Not applicable | Male and Female | 50 | Not selected | Japan | ||
| 302 | NCT02522780 | February 1, 2016 | 16 September 2019 | Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC) | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 2 g Extended Release Granules (Sachet) for Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis | Ulcerative Colitis | Drug: Mesalamine;Drug: Placebo | Ferring Pharmaceuticals | Not recruiting | 18 Years | 75 Years | All | 276 | Phase 3 | United States;Bulgaria;Canada;Hungary;Latvia;Mexico;Poland;Russian Federation;Serbia;Switzerland;Ukraine;Belgium | |
| 303 | NCT02579733 | February 1, 2016 | 26 August 2019 | Azathioprine Based on Endoscopy After Clinical Remission in Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: Azathioprine;Drug: Placebo | Kyungpook National University | Celltrion | Not recruiting | 18 Years | 80 Years | All | 16 | Phase 4 | Korea, Republic of | |
| 304 | NCT02683733 | February 2016 | 14 March 2016 | Bio-enhanced Curcumin as an Add-On Treatment in Mild to Moderate Ulcerative Colitis | The Efficacy and Tolerability of Bio-enhanced Curcumin (Diferuloylmethane) in the Induction of Remission in Patients With Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Dietary Supplement: Bio-enhanced Curcumin Soft Gelatin Capsule;Drug: 5-Aminosalicylic acid | Asian Institute of Gastroenterology, India | Recruiting | 18 Years | 70 Years | Both | 50 | Phase 3 | India | |
| 305 | NCT02683759 | February 2016 | 14 March 2016 | Bio-enhanced Curcumin as an Add-on Treatment in Maintaining Remission of Ulcerative Colitis | The Efficacy and Tolerability of Bio-Enhanced Curcumin in Maintaining Remission in Patients With Ulcerative Colitis | Ulcerative Colitis | Dietary Supplement: Bio-enhanced Curcumin Soft Gelatin Capsule;Drug: 5-Aminosalicyclic acid | Asian Institute of Gastroenterology, India | Recruiting | 18 Years | 70 Years | Both | 50 | Phase 3 | India | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 306 | EUCTR2015-000319-41-NL | 26/01/2016 | 28 February 2019 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC103 Product Code: RPC1063 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod Current Sponsor code: RPC1063 Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: 1.0 mg RPC103 Product Code: RPC1063 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod Current Sponsor code: RPC1063 Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Celgene International II Sàrl (CIS II) | Authorised | Female: yes Male: yes | 900 | Phase 3 | Serbia;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Netherlands;Latvia;Moldova, Republic of;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand | |||
| 307 | EUCTR2015-001555-69-HU | 15/01/2016 | 26 November 2018 | A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis. | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis | Moderately Active Ulcerative Colitis, defined as: •Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity); •Endoscopy subscore (mMES determined by a central reader) of at least 2; and •Disease that extends = 15 cm from the anal verge. MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KHK4083 Product Code: KHK4083 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Not available Current Sponsor code: KHK4083 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Kyowa Kirin Pharmaceutical Development, Inc. | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Serbia;United States;Czech Republic;Hungary;Poland;Russian Federation | |||
| 308 | JPRN-UMIN000022954 | 2016/01/15 | 2 April 2019 | A study related to usability of Mesalazine Controlled-Release Tablets and Granules. | ulcerative colitis | Patients take Mesalazine Controlled-release tablets at first, 3-12 weeks, then take granules, 3-12 weeks Patients take Mesalazine Controlled-release granules at first, 3-12 weeks, then take tablets, 3-12 weeks | Kitasato University Kitasato Institute Hospital | Recruiting | Not applicable | 100years-old | Male and Female | 60 | Not applicable | Japan | ||
| 309 | NCT02618187 | January 13, 2016 | 3 September 2018 | A Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative Colitis | A Phase 1B Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: Eubacterial Spores, Purified Suspension, Encapsulated;Drug: Placebo;Drug: Placebo Pre-Treat;Drug: Vancomycin Pre-Treat | Seres Therapeutics, Inc. | Not recruiting | 18 Years | 75 Years | All | 58 | Phase 1 | United States | |
| 310 | NCT02742597 | January 12, 2016 | 8 January 2018 | Patient-Centred Innovations for Persons With Multimorbidity - Ontario | Patient-Centred Innovations for Persons With Multimorbidity - Ontario | Hypertension;Depression;Anxiety;Musculoskeletal Pain;Arthritis;Rheumatoid Arthritis;Osteoporosis;Chronic Obstructive Pulmonary Disease (COPD);Asthma;Chronic Bronchitis;Cardiovascular Disease;Heart Failure;Stroke;Transient Ischemic Attacks;Ulcer;Gastroesophageal Reflux;Irritable Bowel;Crohn's Disease;Ulcerative Colitis;Diverticulosis;Chronic Hepatitis;Diabetes;Thyroid Disorder;Cancer;Kidney Disease;Urinary Tract Problem;Dementia;Alzheimer's Disease;Hyperlipidemia;HIV;Multimorbidity | Behavioral: TIP / IMPACT Plus Care Coordination | Lawson Health Research Institute | Western University, Canada;Université de Sherbrooke;Canadian Institutes of Health Research (CIHR);Sunnybrook Health Sciences Centre;St. Michael's Hospital, Toronto;University Health Network, Toronto;Toronto East General Hospital;Providence HealthCare;Mount Sinai Hospital, Canada;Toronto Central Community Care Access Centre;Women's College Hospital | Not recruiting | 18 Years | 80 Years | All | 1980 | N/A | Canada |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 311 | EUCTR2015-002109-12-LV | 08/01/2016 | 26 November 2018 | A study that continues from APD334-003 which investigates the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease) | An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: APD334 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Not yet available Other descriptive name: APD334 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Arena Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Ukraine;Lithuania;Austria;Russian Federation;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand | |||
| 312 | NCT02611830 | January 8, 2016 | 10 September 2018 | Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, With a Vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy | Colitis, Ulcerative | Drug: Vedolizumab IV 300 mg;Drug: Placebo IV;Drug: Vedolizumab SC 108 mg;Drug: Placebo SC | Takeda | Not recruiting | 18 Years | 80 Years | All | 384 | Phase 3 | United States;Argentina;Australia;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Colombia;Czech Republic | |
| 313 | NCT02493712 | January 2016 | 26 August 2019 | A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M | A Phase 2a, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients With Active, Mild to Moderate Ulcerative Colitis | Colitis, Ulcerative | Drug: High dose;Drug: Low dose;Drug: Placebo | Holy Stone Healthcare Co., Ltd | inVentiv Health Clinical | Not recruiting | 18 Years | 75 Years | All | 51 | Phase 2 | Italy;Taiwan |
| 314 | EUCTR2015-004724-62-IE | 22/12/2015 | 23 July 2018 | Golimumab dose variation to achieve response in Colitis | Golimumab (GLM) dose Optimisation to Adequate Levels to Achieve Response in Colitis. (GOAL-ARC) | Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Simponi Product Name: Simponi Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: GOLIMUMAB CAS Number: 476181-74-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- INN or Proposed INN: GOLIMUMAB CAS Number: 476181-74-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | UCD | Authorised | Female: yes Male: yes | 136 | Phase 4 | Ireland | |||
| 315 | EUCTR2015-001942-28-CZ | 10/12/2015 | 3 April 2017 | A study to investigate the safety and effectiveness of treatment with the drug APD334 in patients with ulcerative colitis (a form of inflammatory bowel disease) | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: APD334 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Not yet available Current Sponsor code: APD334 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Code: APD334 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Not yet available Current Sponsor code: APD334 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Arena Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Ukraine;Lithuania;Austria;Israel;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Latvia;Germany;New Zealand | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 316 | NCT02531126 | December 2, 2015 | 4 November 2019 | Open-Label Extension of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: RPC1063 | Celgene | Recruiting | 12 Years | N/A | All | 890 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Croatia;Czechia;Georgia;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Moldova, Republic of;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Czech Republic | |
| 317 | EUCTR2015-001022-42-IT | 01/12/2015 | 30 April 2019 | A Phase 2a, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients with Active, Mild to Moderate Ulcerative Colitis | A Phase 2a, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial of IBD98-M Delayed-release Capsules to Induce Remission in Patients with Active, Mild to Moderate Ulcerative Colitis | Active, Mild to Moderate Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: IBD98-M Delayed-release Capsules Product Code: IBD98-M Pharmaceutical Form: Capsule INN or Proposed INN: SODIUM HYALURONATE CAS Number: 9067-32-7 Other descriptive name: SODIUM HYALURONATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 23- INN or Proposed INN: MESALAZINE CAS Number: 89-57-6 Other descriptive name: Mesalamine, 5-ASA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Holy Stone Healthcare Co., Ltd. | Not Recruiting | Female: yes Male: yes | 51 | Phase 2 | Italy | |||
| 318 | NCT02368743 | December 2015 | 16 July 2018 | QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®) | QUality of Life in pAtients With Mild to modeRate Active procTitis Treated by mesalaZine (Pentasa®) | Distal Ulcerative Colitis | Drug: mesalazine | Ferring Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 117 | Phase 2 | France | |
| 319 | NCT02390726 | December 2015 | 16 July 2018 | Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis | Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis | Ulcerative Colitis, Active Moderate | Biological: Fecal Microbiota Transplant;Biological: Placebo | University of Vermont | Not recruiting | 18 Years | 75 Years | All | 20 | Early Phase 1 | United States | |
| 320 | NCT02586259 | December 2015 | 26 August 2019 | Effectiveness of Cortiment® in Patients With Ulcerative Colitis | A Prospective Multi-centre Observational Cohort Study Assessing the Effectiveness of Cortiment® for the Treatment of Mild-to-moderate Active Ulcerative Colitis in Routine Clinical Practice | Ulcerative Colitis | Drug: budesonide MMX® | Ferring Pharmaceuticals | Not recruiting | 18 Years | N/A | All | 378 | Phase 2/Phase 3 | Canada;Germany;Ireland;Italy;Netherlands;Poland;Sweden;United Kingdom;Israel;Switzerland | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 321 | NCT02636517 | December 2015 | 18 December 2018 | Fecal Microbiome Transplant | Fecal Microbiome Transplant in Pediatric C. Difficile | Clostridium Difficile;Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis | Biological: Fecal Microbiota Transplant | Children's Hospital of Philadelphia | Recruiting | 3 Years | 21 Years | All | 50 | N/A | United States | |
| 322 | NCT02632175 | November 26, 2015 | 18 March 2019 | Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis | A Multi-Center, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate Long-Term Safety and Tolerability of Repeated Administration of Adalimumab in Pediatric Subjects With Ulcerative Colitis Who Completed the Study M11-290 | Ulcerative Colitis (UC) | Biological: Adalimumab | AbbVie | Recruiting | 5 Years | 18 Years | All | 93 | Phase 3 | United States;Japan;Poland;Slovakia;Spain;United Kingdom | |
| 323 | NCT02330653 | November 2015 | 3 June 2019 | Fecal Microbiota Transplant (FMT) in Pediatric Active Ulcerative Colitis | A Phase I/II, Double Blinded, Placebo Controlled, Single-center Study of Fecal Microbiota Transplant (FMT) for the Treatment of Active Pediatric Ulcerative Colitis | Inflammatory Bowel Diseases;Ulcerative Colitis | Biological: Fecal Microbiota Transplant;Biological: Placebo | Stacy A. Kahn | Not recruiting | 5 Years | 30 Years | All | 11 | Phase 1/Phase 2 | United States | |
| 324 | NCT02487238 | November 2015 | 11 February 2019 | Pediatric FEcal Microbiota Transplant for Ulcerative Colitis | A Single-Blind, Randomized, Placebo-Controlled Trial of Human Fecal Microbiota Transplantation for the Therapy of Pediatric Ulcerative Colitis and Inflammatory Bowel Disease Unclassified | Inflammatory Bowel Disease;Ulcerative Colitis | Biological: Fecal Microbiota Enema;Biological: Normal Saline Enema | McMaster Children's Hospital | London Health Sciences Centre;St. Justine's Hospital | Not recruiting | 3 Years | 17 Years | All | 35 | Phase 1 | Canada |
| 325 | NCT02536404 | November 2015 | 11 November 2019 | Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis | Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod;Drug: Placebo | Arena Pharmaceuticals | Not recruiting | 18 Years | 80 Years | All | 118 | Phase 2 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Israel;Latvia;Lithuania;New Zealand;Poland;Romania;Spain;Ukraine;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 326 | JPRN-UMIN000021460 | 2015/10/20 | 2 April 2019 | Chromoendoscopic method using an acetic acid indigocarmine mixture for diagnostic accuracy in delineating margin of colitic cancer. | patients with ulcerative colitis had high risk of colitic cancer. A:patients suspected dysplasia(low/high grade) or cancer. B:patients had plan of treatment of the dysplasia or cancer. | 40mL AIM solution (0.6% acetic acid with 0.4% IC) was sprinkled onto the lesions and images were recorded. | Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences | Recruiting | 20years-old | 80years-old | Male and Female | 30 | Not selected | Japan | ||
| 327 | EUCTR2015-001600-64-CZ | 14/10/2015 | 23 July 2018 | The purpose of this study is to determine whether long-term RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Open-Label Extension Trial of Oral RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of long-term RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Product Code: RPC1063 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod Current Sponsor code: RPC1063 Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Product Name: 1.0 mg RPC1063 Product Code: RPC1063 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Ozanimod Current Sponsor code: RPC1063 Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0- | Celgene International II Sàrl | Authorised | Female: yes Male: yes | 1200 | Phase 3 | United States;Belarus;Slovakia;Ukraine;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Poland;Belgium;Croatia;Australia;South Africa;Bulgaria;Latvia;Netherlands;Germany;New Zealand;Korea, Republic of | |||
| 328 | ChiCTR-IOR-15007194 | 2015-10-10 | 18 April 2017 | The randomized, controlled, double blind clinical trial of Qingchang Wenzhongs in the treatment of ulcerative colitis. | The randomized, controlled, double blind clinical trial of Qingchang Wenzhongs in the treatment of ulcerative colitis. | Ulreative colitis | Qing chang wen zhong: Qing chang wen zhong of traditional Chinese medicine;Mesalazine:Mesalazine; | Dongfang hospital, Beijing univetsity of Chinese Medicine | Recruiting | 16 | 65 | Both | Qing chang wen zhong:36;Mesalazine:36; | Other | China | |
| 329 | ChiCTR-ICR-15007188 | 2015-10-09 | 18 April 2017 | Percutaneous endoscopic mini-colostomy anddrug delivery system for the treatment of ulcerative colitis: A randomized, controlled clinical trial | Percutaneous endoscopic mini-colostomy anddrug delivery system for the treatment of ulcerative colitis: A randomized, controlled clinical trial | Ulcerative colitis | Percutaneous endoscopic mini-colostomy group:Oral steroids (prednisone 1mg.kg-1d-1) +Percutaneous endoscopic mini-colostomy andsubsequent drug delivery (mesalazine 3g / d);Control Group:Oral steroids (prednisone 1mg.kg-1d-1) andmesalazine 3g / d; | Southern Medical University, Nanfang Hospital, Department of Gastroenterology | Recruiting | Both | Percutaneous endoscopic mini-colostomy group:21;Control Group:21; | New Treatment Measure Clinical Study | China | |||
| 330 | NCT02522767 | October 2015 | 8 April 2019 | Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC) | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Investigating the Efficacy and Safety of Mesalamine 4 g Extended Release Granules (Sachet) for the Induction of Clinical and Endoscopic Remission in Active, Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: Mesalamine;Drug: Placebo | Ferring Pharmaceuticals | Not recruiting | 18 Years | 75 Years | All | 228 | Phase 3 | United States;Bulgaria;Canada;Hungary;Latvia;Mexico;Poland;Russian Federation;Serbia;Switzerland;Ukraine;Belgium | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 331 | NCT02550418 | October 2015 | 16 December 2017 | Budesonide 9 mg Capsules in Active UC | Open-label, Multi-centre, Proof of Concept Phase IIa Clinical Trial on the Efficacy and Tolerability of an 8 Week Oral Treatment With Once Daily 9 mg Budesonide in Patients With Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Budesonide | Dr. Falk Pharma GmbH | Not recruiting | 18 Years | 75 Years | All | 60 | Phase 2 | Germany | |
| 332 | JPRN-UMIN000019066 | 2015/09/25 | 2 April 2019 | An open label randomized controlled trial of combination therapy of Adalimumab and GMA for intractable ulcerative colitis | Ulcerative colitis | Administration of Adalimumab 160 mg at baseline, 80 mg at 2 weeks and 40 mg every 2 weeks. In addition to Adalimumab Therapy, co-treatment of GMA 3times a week up to 2 weeks | Sakura Medical Center,Toho university | Not Recruiting | 20years-old | Not applicable | Male and Female | 58 | Not applicable | Japan | ||
| 333 | JPRN-UMIN000018745 | 2015/09/01 | 2 April 2019 | The Efficacy of Enternal Nutrition in Active Ulcerative Colitis Patients with Hypoalbuminemia ,during Infliximab Therapy | ulcerative colitis | Administration of Infliximab and enteral nutrition Administration of Infliximab | Nagoya University Graduate School of Medicine, Department of Gastroentrology and hepatology | Not Recruiting | 15years-old | 75years-old | Male and Female | 40 | Not selected | Japan | ||
| 334 | NCT02084550 | September 2015 | 16 December 2017 | Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis | Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis: a Randomized, Assessor-blinded, Placebo-controlled Trial | Ulcerative Colitis | Dietary Supplement: Vaminolac;Other: Saline | Aarhus University Hospital | Not recruiting | 18 Years | 50 Years | All | 8 | N/A | Denmark | |
| 335 | NCT02520284 | September 2015 | 16 December 2017 | Safety and Efficacy of GS-5745 in Adults With Moderately to Severely Active Ulcerative Colitis | A Combined Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Induction and Maintenance Study Evaluating the Safety and Efficacy of GS-5745 in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Biological: GS-5745;Biological: Placebo | Gilead Sciences | Not recruiting | 18 Years | 75 Years | All | 165 | Phase 2/Phase 3 | United States;Australia;Belgium;Bulgaria;Canada;Czech Republic;France;Hungary;Ireland;Italy;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Slovakia;South Africa;Switzerland;Taiwan;Ukraine;United Kingdom;Austria;Croatia;Germany;Hong Kong;Iceland;Israel;Serbia;Spain;Sweden | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 336 | NCT02537210 | September 2015 | 20 August 2018 | Aminosalicylic Acid Withdrawal Study in Long Standing Inactive Ulcerative Colitis | Oral 5-aminosalicylic Acid Withdrawal in Long Standing Inactive Ulcerative Colitis: A Double-blind, Randomized, Placebo-controlled Trial | Colitis, Ulcerative;Aminosalicylic Acid | Drug: Mesalazine;Drug: Placebo oral capsule | Chinese University of Hong Kong | Queen Elizabeth Hospital, Hong Kong;Alice Ho Miu Ling Nethersole Hospital;Tseung Kwan O Hospital, Hong Kong | Recruiting | 18 Years | N/A | All | 194 | N/A | Hong Kong;China |
| 337 | JPRN-UMIN000018801 | 2015/08/27 | 2 April 2019 | Efficasy of colonosocopy using carbon dioxide insufflation for the patients with ulcerative colitis | ulcerative colitis | Colonosocopy using carbon dioxide insufflation Colonosocopy using air insufflation | Osaka University, Graduate School of Medicine, Department of Gastroenterology and Hepatology | Recruiting | 16years-old | Not applicable | Male and Female | 250 | Not selected | Japan | ||
| 338 | JPRN-UMIN000018642 | 2015/08/12 | 2 April 2019 | A trial of fecal microbiota transplantation and / or antibiotics therapy for ulcerative colitis | ulcerative colitis | Antibiotics therapy:Taking three kinds of antibiotics (Amoxicillin, fosmycin, metronidazole) for two weeks. FMT:Administration of the fecal material from healthy donors to patients. | Juntendo university school of medicine Department of gastroenterology | Recruiting | 6years-old | Not applicable | Male and Female | 50 | Not selected | Japan | ||
| 339 | EUCTR2014-005443-40-NL | 15/07/2015 | 4 August 2015 | An open label study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) LOVE-UC | An open label observational phase 4 study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) LOVE-UC - LOVE-UC | Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Entyvio Pharmaceutical Form: Powder for solution for infusion | Academic Medical Center/ Gastroenterology | Authorised | Female: yes Male: yes | 120 | Phase 4 | Netherlands | |||
| 340 | NCT02497469 | July 15, 2015 | 23 April 2019 | An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis | A Randomized, Double-Blind, Double-Dummy, Multicenter, Active-Controlled Study to Evaluate the Efficacy and Safety of Vedolizumab IV Compared to Adalimumab SC in Subjects With Ulcerative Colitis | Colitis, Ulcerative | Drug: Vedolizumab;Drug: Adalimumab placebo;Drug: Adalimumab;Drug: Vedolizumab placebo | Takeda | Not recruiting | 18 Years | 85 Years | All | 770 | Phase 3 | United States;Argentina;Australia;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Croatia;Czechia;Denmark;Estonia;France;Germany;Hong Kong;Hungary;Israel;Italy;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Taiwan;Turkey;Ukraine;United Kingdom;Chile;Czech Republic;Finland;Norway;South Africa;Sweden | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 341 | EUCTR2014-005635-14-LV | 10/07/2015 | 3 July 2017 | Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis | Open-label, multi-centre, proof of concept phase IIa clinical trial on the efficacy and tolerability of an 8 week oral treatment with once daily 9 mg budesonide in patients with active ulcerative colitis - Budesonide 9 mg capsules in active UC | Patients with active ulcerative colitis MedDRA version: 18.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 9 mg capsules, hard (BUX-PV) Pharmaceutical Form: Capsule, hard INN or Proposed INN: BUDESONIDE CAS Number: 51333-22-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 9- | Dr. Falk Pharma GmbH | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Lithuania;Latvia | |||
| 342 | NCT02407236 | July 10, 2015 | 11 November 2019 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative;Inflammatory Bowel Diseases | Drug: Placebo IV;Drug: Placebo SC;Drug: Ustekinumab IV;Drug: Ustekinumab SC | Janssen Research & Development, LLC | Not recruiting | 18 Years | N/A | All | 972 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Japan;Korea, Republic of;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;Ukraine;United Kingdom;Czech Republic;South Africa | |
| 343 | NCT01671956 | July 2015 | 18 January 2018 | Evaluation of Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study Designed to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Profile of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis | Ulcerative Colitis, Active Moderate;Ulcerative Colitis, Active Severe | Biological: Bertilimumab;Biological: Placebo | Immune Pharmaceuticals | Recruiting | 18 Years | 70 Years | All | 42 | Phase 2 | Israel | |
| 344 | NCT02426372 | July 2015 | 16 December 2017 | Safety and Efficacy of QBECO in Moderate to Severe Ulcerative Colitis | An Open Label, Dose Ranging, Exploratory Study to Evaluate the Safety, Tolerability, Compliance, Mechanism of Action and Efficacy of QBECO Site Specific Immunomodulation for the Induction of Clinical Response and Remission in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Biological: QBECO SSI | Qu Biologics Inc. | Not recruiting | 19 Years | N/A | All | 11 | Phase 2 | Canada | |
| 345 | NCT02447302 | July 2015 | 25 February 2019 | Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Etrasimod;Drug: Placebo | Arena Pharmaceuticals | Not recruiting | 18 Years | 80 Years | All | 156 | Phase 2 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Israel;Korea, Republic of;Latvia;Lithuania;New Zealand;Poland;Romania;Russian Federation;Spain;Ukraine;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 346 | NCT02646657 | July 2015 | 13 May 2019 | An Open Label Phase 4 Study to Evaluate Efficacy of Early Versus Late Use of Vedolizumab in Ulcerative Colitis | An Open Label Interventional Phase 4 Study to Evaluate Efficacy, Safety and Mucosal Healing of Early Versus Late Use of Vedolizumab in Ulcerative Colitis: the LOVE-UC Study (LOw Countries VEdolizumab in UC Study) | Colitis, Ulcerative | Drug: Vedolizumab 300 mg | Geert D'Haens | Takeda | Recruiting | 18 Years | 80 Years | All | 120 | Phase 4 | Belgium;Hungary;Netherlands |
| 347 | JPRN-UMIN000017844 | 2015/06/22 | 2 April 2019 | Antibiotic combination therapy for ulcerative colitis | ulcerative colitis | amoxicillin, tetracycline, and metronidazole | Shiga University of Medical Science | Not Recruiting | 20years-old | 80years-old | Male and Female | 20 | Not selected | Japan | ||
| 348 | NCT02435992 | June 17, 2015 | 4 November 2019 | Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: RPC1063;Drug: Placebo | Celgene | Recruiting | 12 Years | 75 Years | All | 900 | Phase 3 | United States;Argentina;Australia;Austria;Belarus;Belgium;Bulgaria;Canada;Croatia;Czechia;Georgia;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Latvia;Moldova, Republic of;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Czech Republic | |
| 349 | JPRN-JapicCTI-163122 | 28/5/2015 | 16 July 2019 | A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants with Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative, Inflammatory Bowel Diseases | Intervention name : Ustekinumab Dosage And administration of the intervention : | Janssen Pharmaceutical K.K. | Not Recruiting | 18 | BOTH | 92 | Phase 3 | |||
| 350 | EUCTR2014-004904-31-NL | 19/05/2015 | 5 September 2016 | A clinical study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission. | Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA).;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remsima (infliximab) Pharmaceutical Form: Powder for concentrate for solution for injection/infusion | Mundipharma Pharmaceuticals B.V. | Authorised | Female: yes Male: yes | Phase 4 | Netherlands | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 351 | NCT02413047 | May 2015 | 16 December 2017 | Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator | A Pilot Study to Evaluate if Response to Infliximab or Adalimumab May be Regained With the Addition of an Immunomodulator | Inflammatory Bowel Disease;Ulcerative Colitis;Crohn's Disease | Drug: Azathioprine;Drug: 6 mercaptopurine;Drug: Methotrexate | Indiana University | Recruiting | 18 Years | 80 Years | All | 20 | N/A | United States | |
| 352 | NCT02423460 | May 2015 | 19 November 2018 | Threonine Requirement in IBD Adults and Healthy Adult Controls | Threonine Requirement in Healthy Adult Subjects and in Patients With Crohn's Disease and With Ulcerative Colitis Using the Indicator Amino Acid Oxidation (IAAO) Methodology | Ulcerative Colitis;Crohn's Disease;Healthy | Other: Threonine | Nestlé | The Hospital for Sick Children;Mount Sinai Hospital, Canada | Not recruiting | 18 Years | 40 Years | Male | 86 | N/A | Canada |
| 353 | NCT02435160 | May 2015 | 25 May 2015 | The Study of Efficacy and Mechanism in Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis | Ulcerative Colitis;Fecal Microbiota Transplantation | Biological: Fecal Microbiota Transplantation | Jun Liu | Not recruiting | 25 Years | 60 Years | Male | 20 | Phase 2/Phase 3 | |||
| 354 | NCT02442037 | May 2015 | 25 May 2015 | Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Active Ulcerative Colitis | Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Active Ulcerative Colitis. | Ulcerative Colitis | Biological: UCMSC group;Other: Control group(Normal saline) | Affiliated Hospital to Academy of Military Medical Sciences | Ivy Institute of Stem Cells Co. Ltd | Recruiting | 18 Years | 65 Years | Both | 30 | Phase 1/Phase 2 | China |
| 355 | NCT02463045 | May 2015 | 16 December 2017 | Study for Safety and Tolerability of TOP1288 Administered Rectally in Healthy and Ulcerative Colitis Subjects | A Phase I Study to Evaluate the Safety/Tolerability and Pharmacokinetics of TOP1288 Rectal Single and Multiple Ascending Doses in Healthy Subjects and Multiple Doses in Subjects With Ulcerative Colitis | Ulcerative Colitis | Drug: TOP1288 | Topivert Pharma Ltd | Not recruiting | 18 Years | 55 Years | All | 67 | Phase 1 | United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 356 | NCT02575040 | May 2015 | 26 October 2015 | Efficacy of Fecal Microbiota Transplantation for Inflammatory Bowel Disease | Efficacy of Fecal Microbiota Transplantation for Refractory Inflammatory Bowel Disease | Ulcerative Colitis;Crohn Disease;Constipation (Excl Faecal Impaction) | Biological: Fecal microbiota transplantation | Gulhane Military Medical Academy | Recruiting | 18 Years | N/A | Both | 60 | Phase 3 | Turkey | |
| 357 | NCT02539368 | April 22, 2015 | 26 August 2019 | Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease | POST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD) | Inflammatory Bowel Diseases;Ulcerative Colitis;Crohn's Disease | Drug: CT-P13;Drug: Remicade | Pfizer | Hospira, now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | All | 2565 | Phase 3 | Belgium;Czechia;Finland;France;Germany;Greece;Hungary;Italy;Netherlands;Portugal;Slovakia;Spain;United Kingdom;Czech Republic;Ireland |
| 358 | EUCTR2014-000784-41-DK | 15/04/2015 | 8 January 2018 | Amino acids in j-pouch surgery for ulcerative colitis | Amino acids in ileal pouch-anal anastomosis for ulcerative colitis: a randomized, double-blind placebo-controlled trial - Amino acids in ileal pouch-anal anastomosis | Ileal pouch-anal anastomosis for ulcerative colitis MedDRA version: 18.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Vaminolac, komb. Product Name: Vaminolac, komb. Pharmaceutical Form: Infusion INN or Proposed INN: Vaminolac, komb. Other descriptive name: Vaminolac, komb. Concentration unit: g/l gram(s)/litre Concentration type: equal Concentration number: 65- Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intravenous use | Department of Medicine and Endocrinology | Not Recruiting | Female: yes Male: yes | 24 | Phase 3 | Denmark | |||
| 359 | NCT02674308 | March 31, 2015 | 14 October 2019 | Entyvio (Vedolizumab) Long Term Safety Study | Entyvio (Vedolizumab) Long-term Safety Study: An International Observational Prospective Cohort Study Comparing Vedolizumab to Other Biologic Agents in Patients With Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis and Crohn's Disease | Drug: Vedolizumab;Other: Other Biologic Agents | Takeda | Not recruiting | 18 Years | N/A | All | 5302 | N/A | United States;Austria;Belgium;Canada;Croatia;Denmark;Estonia;France;Germany;Greece;Ireland;Israel;Italy;Netherlands;Norway;Portugal;Slovenia;Spain;Sweden;Switzerland;United Kingdom | |
| 360 | EUCTR2014-002579-27-IT | 03/03/2015 | 7 January 2019 | Pilot study on the efficacy of golimumab in normalizing the symptoms and lesions of the colon-rectum in patients with ulcerative colitis who only respond to therapy with cortisone | Pilot study on the efficacy of golimumab in the induction and maintenance of clinical and endoscopic remission in patients with steroid-dependent ulcerative colitis. - UC-GOL | active steroid-dependent ulcerative colitis MedDRA version: 17.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: SIMPONI Product Name: SIMPONI Product Code: NA Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: GOLIMUMAB CAS Number: 476181-74-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | Istituto Clinico Humanitas | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Italy | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 361 | NCT02368717 | March 2015 | 16 December 2017 | An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension Phase | A Randomized, Double-blind, Placebo-controlled, Multi-centre, Superiority Study Investigating the Efficacy and Safety of PENTASA Enema Compared With Placebo Enema for 4-Week Treatment in Chinese Patients With Left-sided Active Ulcerative Colitis (UC) Followed by a Maximal 28-Week Open-Label Extension Phase of PENTASA Enema and/or PENTASA Tablets | Ulcerative Colitis | Drug: Mesalazine Enema;Drug: Placebo Enema | Ferring Pharmaceuticals | Not recruiting | 18 Years | 70 Years | All | 281 | Phase 3 | China | |
| 362 | NCT02412085 | March 2015 | 20 April 2015 | Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission | Pilot Study to Evaluate the Efficacy of Golimumab for Induction and Maintenance of Clinical and Endoscopic Remission in Patients With Steroid-dependent Ulcerative Colitis | Colitis, Ulcerative | Drug: Golimumab | Istituto Clinico Humanitas | Recruiting | 18 Years | 65 Years | Both | 100 | Phase 4 | Italy | |
| 363 | NCT02318667 | February 27, 2015 | 24 June 2019 | Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022). | An Open Label, Single Group Assignment Design Study to Correlate Soluble ST2 With Clinical, Endoscopic and Histological Activity in Moderate to Severe Ulcerative Colitis Patients Under Golimumab. | Colitis, Ulcerative | Biological: Golimumab | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | 65 Years | All | 38 | Phase 4 | Portugal | |
| 364 | NCT02200445 | February 2015 | 1 April 2019 | Low Dose IL-2 for Ulcerative Colitis | A Phase I Study of Low Dose Subcutaneous Interleukin-2 (IL-2) For The Treatment of Ulcerative Colitis. | Ulcerative Colitis | Drug: Interleukin-2 (aldesleukin). | Scott Snapper | Recruiting | 18 Years | 70 Years | All | 28 | Phase 1 | United States | |
| 365 | NCT02465385 | February 2015 | 8 August 2016 | Single-dose Linaclotide for Capsule Endoscopy Preparation | Single-dose Linaclotide for Capsule Endoscopy Preparation | Crohn's;Ulcerative Colitis;Gastrointestinal Bleeding | Drug: Linaclotide | University of Virginia | Not recruiting | 18 Years | N/A | Both | 30 | Phase 4 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 366 | EUCTR2013-001205-84-DE | 13/01/2015 | 4 December 2018 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo vs. mesalamine for maintenance of remission in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 48-weeks treatment with gastro-resistant phosphatidylcholine (LT-02) versus placebo versus mesalamine for maintenance of remission in patients with ulcerative colitis - Phosphatidylcholine (LT-02) vs. placebo vs. mesalamine for maintenance of remission in UC | Maintenance of remission in ulcerative colitis (UC) MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 Pharmaceutical Form: Gastro-resistant granules INN or Proposed INN: Phosphatidylcholine CAS Number: 97281-47-5 Current Sponsor code: LT-02 Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 800- Pharmaceutical form of the placebo: Gastro-resistant granules Route of administration of the placebo: Oral use Trade Name: Salofalk Granu-Stix 500 mg Pharmaceutical Form: Gastro-resistant granules INN or Proposed INN: MESALAZINE CAS Number: 89-57-6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Pharmaceutical form of the placebo: Gastro-resistant granules Route of administration of the placebo: Oral use | Dr. Falk Pharma GmbH | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands | |||
| 367 | ChiCTR-IPR-15005760 | 2015-01-12 | 18 April 2017 | Steroid-dependent ulcerative colitis pathogenesis of complex multi-center alternative medicine therapy, randomized, controlled clinical study | Steroid-dependent ulcerative colitis pathogenesis of complex multi-center alternative medicine therapy, randomized, controlled clinical study | ulcerative colitis | TCM Group:Oral Chinese medicine Qinchang Lianyang Granule + Guanchang Fang granule;Control:Azathioprine; | Affiliated Hospital of Nanjing University of Chinese Medicine | Not Recruiting | 18 | 65 | Both | TCM Group:60;Control:60; | Phase 1 study | China | |
| 368 | NCT03441893 | January 1, 2015 | 20 August 2018 | Role of Intestinal Protozoa and Helminths in the Course of Ulcerative Colitis | Role of Intestinal Protozoa and Helminths in the Course of Ulcerative Colitis | Ulcerative Colitis;Ulcerative Colitis Exacerbation;Protozoan Infections;Helminth Infection | Diagnostic Test: parasitological diagnostics (coproscopy);Drug: Nitazoxanide 500Mg Oral Tablet;Drug: Mesalazine 250Mg Tablet and nitazoxanide 500Mg Oral Tablet;Drug: Mesalazine 250Mg | Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan | Not recruiting | 18 Years | 90 Years | All | 300 | Phase 1/Phase 2 | ||
| 369 | NCT02261636 | January 2015 | 25 February 2019 | Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment | Ulcerative Colitis | Drug: mesalazine | Ferring Pharmaceuticals | Not recruiting | 18 Years | 70 Years | All | 150 | Phase 1 | Netherlands | ||
| 370 | NCT02335281 | January 2015 | 19 February 2015 | Standardized Fecal Microbiota Transplantation for Inflammatory Bowel Disease | Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation for Severe Inflammatory Bowel Disease | Inflammatory Bowel Disease;Ulcerative Colitis;Crohn's Disease | Procedure: FMT;Drug: Mesalazine | Yanling Wei | Recruiting | 16 Years | 70 Years | Both | 40 | Phase 2 | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 371 | NCT02136069 | December 24, 2014 | 20 May 2019 | A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors | Phase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors | Ulcerative Colitis | Drug: etrolizumab;Drug: infliximab;Other: placebo (IV);Other: placebo (injection) | Hoffmann-La Roche | Not recruiting | 18 Years | 80 Years | All | 390 | Phase 3 | Romania;Singapore;South Africa;Spain;Sweden;Switzerland;United Kingdom;Czech Republic;Vietnam;Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Netherlands;Norway;Philippines;Portugal | |
| 372 | JPRN-JapicCTI-142649 | 22/12/2014 | 7 October 2019 | Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis [M11-290] | Ulcerateive Colotis | Intervention name : abalimumab INN of the intervention : Adalimumab Dosage And administration of the intervention : subcutaneous injection Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : subcutaneous injection | AbbVie GK | Not Recruiting | 4 | 17 | BOTH | 9 | Phase 3 | Japan | |
| 373 | JPRN-UMIN000015912 | 2014/12/15 | 2 April 2019 | Efficacy of maintenance therapy with adalimumab in ulcerative colitis achieving remission with tacrolimus | ulcerative colitis | Tacrolimus will be decreased gradually three months after it was administered. Adalimumab will be administrated three months after tacrolimus was administered, and tacrolimus will be decreased gradually. | Osaka Medical College | Recruiting | 16years-old | 70years-old | Male and Female | 50 | Not applicable | Japan | ||
| 374 | EUCTR2014-003262-25-PT | 12/12/2014 | 11 December 2017 | Study to correlate a new biomarker (ST2) with clinical activity in Ulcerative Colitis patients under golimumab | An open label, single group assignment design study to correlate soluble ST2 with clinical, endoscopic and histological activity in moderate to severe Ulcerative Colitis patients under golimumab - EVOLUTION | Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: GOLIMUMAB CAS Number: 476181-74-5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- | Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. | Not Recruiting | Female: yes Male: yes | 37 | Phase 4 | Portugal | |||
| 375 | NCT02093663 | December 12, 2014 | 10 December 2018 | Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis, in Both Acute and Maintenance Phases | Ulcerative Colitis | Drug: MMX Mesalamine/Mesalazine (Low Dose);Drug: MMX Mesalamine/Mesalazine (High Dose) | Shire | Not recruiting | 5 Years | 17 Years | All | 167 | Phase 3 | United States;Canada;Hungary;Israel;Poland;Slovakia;United Kingdom;Belgium;Germany;Netherlands | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 376 | NCT02289417 | December 10, 2014 | 26 August 2019 | Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis | A Phase 2, Randomized, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Apremilast (CC-10004) for Treatment of Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Drug: Apremilast;Drug: Placebo | Celgene | Not recruiting | 18 Years | N/A | All | 170 | Phase 2 | United States;Australia;Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Netherlands;New Zealand;Poland;Russian Federation;Ukraine;Czech Republic | |
| 377 | EUCTR2014-001893-32-HU | 08/12/2014 | 16 November 2015 | Placebo-controlled study to assess efficicay, safety and tolerability and to investigate the pharmacokinetics of GLPG1205 in subjects with moderate to severe Ulcerative Colitis | Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 18.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG1205 Product Code: G321605 Pharmaceutical Form: Capsule, hard Current Sponsor code: G321605 Other descriptive name: GLPG1205 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Galapagos NV | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Czech Republic;Hungary;Poland;Belgium;Russian Federation;Germany | |||
| 378 | NCT02442960 | December 2014 | 13 May 2019 | Evaluating Safety and Efficacy of Herbal Treatment in Ulcerative Colitis | An Open-Label, Dose-Escalation Phase Ib Study Evaluating the Safety and Preliminary Efficacy of Oral SA100 in the Treatment of Patients With Mild, Moderate or Severe Ulcerative Colitis | Ulcerative Colitis | Drug: Herbal treatment (SA100) | Stanford University | Not recruiting | 13 Years | 75 Years | All | 15 | Phase 1 | United States | |
| 379 | EUCTR2013-004280-31-DE | 24/11/2014 | 28 February 2019 | A study to investigate the effectiveness (efficacy) and safety of etrolizumab treatment in maintaining disease remission in ulcerative colitis patients who have not previously been treated with TNF inhibitors | PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY (MAINTENANCE OF REMISSION) AND SAFETY OF ETROLIZUMAB COMPARED WITH PLACEBO IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - LAUREL | Ulcerative colitis (UC) MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Etrolizumab CAS Number: 1044758-60-2 Current Sponsor code: RO5490261 Other descriptive name: ETROLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 105- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use | F. Hoffmann-La Roche Ltd | Authorised | Female: yes Male: yes | 350 | Phase 3 | United States;Slovakia;Ukraine;Israel;Italy;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Denmark;South Africa;Germany | |||
| 380 | NCT02171429 | November 14, 2014 | 11 November 2019 | A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors (Study #2) | Phase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF Inhibitors | Ulcerative Colitis | Drug: Adalimumab;Other: Adalimumab Placebo;Drug: Etrolizumab;Other: Etrolizumab Placebo | Hoffmann-La Roche | Recruiting | 18 Years | 80 Years | All | 350 | Phase 3 | United States;Argentina;Australia;Brazil;Bulgaria;Colombia;Croatia;Czechia;Greece;Hungary;Latvia;Lithuania;Malaysia;New Zealand;Poland;Russian Federation;Turkey;Ukraine | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 381 | EUCTR2013-004282-14-DE | 10/11/2014 | 28 February 2019 | A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA | Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Etrolizumab CAS Number: 1044758-60-2 Current Sponsor code: RO5490261 Other descriptive name: ETROLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 105- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Trade Name: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Current Sponsor code: RO6897845 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | F. Hoffmann-La Roche Ltd | Authorised | Female: yes Male: yes | 390 | Phase 3 | Portugal;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden | |||
| 382 | NCT02163759 | November 4, 2014 | 11 November 2019 | A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors (Study #1) | Phase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF Inhibitors | Ulcerative Colitis | Drug: Adalimumab;Other: Adalimumab Placebo;Drug: Etrolizumab;Other: Etrolizumab Placebo | Hoffmann-La Roche | Recruiting | 18 Years | 80 Years | All | 350 | Phase 3 | Russian Federation;Serbia;Slovakia;Ukraine;Argentina;Australia;Brazil;Bulgaria;United States;Estonia;France;Hong Kong;Mexico;Poland | |
| 383 | JPRN-JapicCTI-142704 | 01/11/2014 | 2 April 2019 | Phase III study of AJG511 in patients with active ulcerative colitis | Phase III study of AJG511 in patients with active ulcerative colitis | ulcerative colitis | Intervention name : AJG511 INN of the intervention : budesonide Dosage And administration of the intervention : intrarectal Control intervention name : Placebo Dosage And administration of the control intervention : intrarectal | EA Pharma Co.,Ltd. | 16 | BOTH | 120 | Phase 3 | ||||
| 384 | NCT02361957 | November 2014 | 7 September 2015 | The Effect of the Multispecies Probiotic Ecologic 825 Versus Placebo in Ulcerative Colitis Patients | The Effect of the Multispecies Probiotic Ecologic 825 Versus Placebo in Ulcerative Colitis Patients | Ulcerative Colitis | Dietary Supplement: Ecologic 825;Dietary Supplement: Placebo | Wageningen University | Not recruiting | 18 Years | 65 Years | Both | 40 | N/A | Netherlands | |
| 385 | EUCTR2013-003032-77-GB | 30/10/2014 | 12 February 2018 | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects with Moderate to Severe Ulcerative Colitis. | Ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg/0.8 ml solution for injection for paediatric use Product Name: ADALIMUMAB Product Code: 331731-18-1 Pharmaceutical Form: Solution for injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Current Sponsor code: Humira Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | AbbVie Deutschland GmbH & Co. KG | Authorised | Female: yes Male: yes | 85 | Phase 3 | United States;Slovakia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;New Zealand | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 386 | ChiCTR1800016668 | 2014-10-22 | 18 June 2018 | A randomized, double-blind, double-dummy, positive controlled clinical trial of Hudi enteric-coated capsules, mesalazine, and combination therapy for active ulcerative colitis (damp-heat syndrome) | A randomized, double-blind, double-dummy, positive controlled clinical trial of Hudi enteric-coated capsules, mesalazine, and combination therapy for active ulcerative colitis (damp-heat syndrome) | Active ulcerative colitis | test group:Hudi enteric-coated capsules+Mesalazine enteric-coated tablets Simulator;Positive control group:Mesalazine enteric-coated tablets+Hudi Enteric-coated Capsule Simulator;Combined group:Hudi enteric-coated capsules+Mesalazine enteric-coated tablets; | Affiliated Hospital of Nanjing University of Traditional Chinese Medicine (Jiangsu Province Traditional Chinese Medicine Hospital) | Not Recruiting | 18 | 65 | Both | test group:120;Positive control group:120;Combined group:120; | Post-market | China | |
| 387 | EUCTR2013-004278-88-DE | 20/10/2014 | 28 February 2019 | A study to investigate the effectiveness (efficacy) and safety of etrolizumab in ulcerative colitis patients who have been previously exposed to TNF inhibitors. | PHASE III, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE EFFICACY AND SAFETY OF ETROLIZUMAB DURING INDUCTION AND MAINTENANCE IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO HAVE BEEN PREVIOUSLY EXPOSED TO TNF INHIBITORS - HICKORY | Ulcerative colitis (UC) MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: etrolizumab Product Code: Ro 549-0261/F04 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ETROLIZUMAB CAS Number: 1044758-60-2 Current Sponsor code: RO5490261 Other descriptive name: rhuMAb Beta7, Anti Beta7, PRO145223 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 105- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use | F. Hoffmann-La Roche Ltd | Authorised | Female: yes Male: yes | 605 | Phase 3 | United States;Greece;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Australia;Denmark;Netherlands;Germany;Korea, Republic of | |||
| 388 | NCT02065557 | October 13, 2014 | 15 July 2019 | Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis | A Multicenter, Randomized, Double-Blind Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis (UC) | Biological: Adalimumab | AbbVie | Not recruiting | 4 Years | 17 Years | All | 100 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czechia;Hungary;Israel;Japan;New Zealand;Poland;Slovakia;Spain;United Kingdom;Czech Republic;Italy;Sweden | |
| 389 | NCT02148640 | October 2014 | 16 December 2017 | The NOR-SWITCH Study | A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SWITCHING FROM INNOVATOR INFLIXIMAB TO BIOSIMILAR INFLIXIMAB COMPARED WITH CONTINUED TREATMENT WITH INNOVATOR INFLIXIMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS, SPONDYLOARTHRITIS, PSORIATIC ARTHRITIS, ULCERATIVE COLITIS, CROHN'S DISEASE AND CHRONIC PLAQUE PSORIASIS THE NOR-SWITCH STUDY | Rheumatoid Arthritis;Spondyloarthritis;Psoriatic Arthritis;Ulcerative Colitis;Crohn's Disease;Psoriasis Chronic | Drug: Innovator infliximab;Drug: Biosimilar infliximab | Diakonhjemmet Hospital | South-Eastern Norway Regional Health Authority | Not recruiting | 18 Years | N/A | All | 482 | Phase 4 | Norway |
| 390 | NCT02217722 | October 2014 | 22 August 2016 | Use of the Ulcerative Colitis Diet for Induction of Remission | An Open Label Non Randomized Pilot Study: Use of the Ulcerative Colitis Diet for Induction of Remission. | Ulcerative Colitis (UC) | Other: Ulcerative Colitis Diet;Drug: Antibiotic cocktail | Prof. Arie Levine | Not recruiting | 5 Years | 18 Years | Both | 9 | N/A | Israel | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 391 | NCT02266849 | October 2014 | 17 October 2016 | Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study | Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study | Rectal Cancer;Ulcerative Colitis;Short Bowel Syndrome | Drug: Loperamide;Drug: Placebo | Odense University Hospital | Not recruiting | 18 Years | N/A | Both | 12 | Phase 3 | Denmark | |
| 392 | NCT02280629 | October 2014 | 11 June 2018 | Phosphatidylcholine (LT-02) vs. Placebo vs. Mesalamine for Maintenance of Remission in Ulcerative Colitis (PROTECT-2) | Randomized, Double-blind, Double-dummy, Placebo-controlled, Phase III Clinical Trial on the Efficacy and Safety of a 48-weeks Treatment With Gastro-resistant Phosphatidylcholine (LT-02) Versus Placebo Versus Mesalamine for Maintenance of Remission in Patients With Ulcerative Colitis | Ulcerative Colitis | Drug: LT-02;Drug: Placebo;Drug: Mesalamine | Dr. Falk Pharma GmbH | Not recruiting | 18 Years | 70 Years | All | 150 | Phase 3 | Germany | |
| 393 | EUCTR2013-004282-14-GB | 29/09/2014 | 28 February 2019 | A study to evaluate the effectiveness (efficacy) and safety of etrolizumab compared with infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA | Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Etrolizumab CAS Number: 1044758-60-2 Current Sponsor code: RO5490261 Other descriptive name: ETROLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 105- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Trade Name: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Current Sponsor code: RO6897845 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | F. Hoffmann-La Roche Ltd | Authorised | Female: yes Male: yes | 390 | Phase 3 | Portugal;Spain;Austria;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden | |||
| 394 | NCT02118584 | September 15, 2014 | 11 November 2019 | Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies | An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase II/III Studies | Ulcerative Colitis | Drug: Etrolizumab | Hoffmann-La Roche | Recruiting | 18 Years | N/A | All | 2100 | Phase 3 | Malaysia;Mexico;Netherlands;New Zealand;Norway;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Singapore;Slovakia;South Africa;Spain;Sweden;Switzerland;Turkey;Ukraine;United Kingdom;Vietnam;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Colombia;Croatia;Czechia;Denmark;Estonia;Lithuania;Latvia;Korea, Republic of;Italy;Israel;India;Hungary;Hong Kong;Greece;Germany;France;United States;Czech Republic | |
| 395 | JPRN-UMIN000015068 | 2014/09/05 | 2 April 2019 | An open label randomized controlled trial of GMA and Infliximab in intractable ulcerative colitis | Ulcerative colitis | Infliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks GMA will be administrated 10 times | Hiroshima University Hospital, Department of Endoscopy | Recruiting | 20years-old | Not applicable | Male and Female | 150 | Not applicable | Japan | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 396 | EUCTR2013-004282-14-AT | 03/09/2014 | 28 February 2019 | A study to evaluate the effectiveness (efficacy) and safety of Etrolizumab compared with Infliximab in patients with moderate to severe ulcerative colitis who have not previously received TNF inhibitors | PHASE III, RANDOMIZED, MULTICENTER DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ETROLIZUMAB COMPARED WITH INFLIXIMAB IN PATIENTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS WHO ARE NAIVE TO TNF INHIBITORS - GARDENIA | Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrolizumab Product Code: Ro 549-0261/F04 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Etrolizumab CAS Number: 1044758-60-2 Current Sponsor code: RO5490261 Other descriptive name: ETROLIZUMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 105- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use Trade Name: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Current Sponsor code: RO6897845 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | F. Hoffmann-La Roche Ltd | Authorised | Female: yes Male: yes | 390 | Phase 3 | Portugal;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Singapore;Romania;South Africa;Norway;Netherlands;Germany;Korea, Republic of;Sweden | |||
| 397 | NCT02108821 | September 2014 | 16 December 2017 | Fecal Microbiota Transplantation in Pediatric Patients | A Study of Fecal Microbiota Transplantation in Pediatric Patients With Relapsed Inflammatory Bowel Disease. | Inflammatory Bowel Diseases (IBD);Crohn's Disease (CD);Ulcerative Colitis (UC) | Biological: Fecal Microbiota Transplantation (FMT) | Children's Mercy Hospital Kansas City | University of Pittsburgh | Not recruiting | 2 Years | 22 Years | All | 23 | Phase 1 | United States |
| 398 | NCT02165215 | August 12, 2014 | 4 November 2019 | A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors | Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Maintenance of Remission) and Safety of Etrolizumab Compared With Placebo in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors | Colitis, Ulcerative | Drug: Etrolizumab;Drug: Placebo | Hoffmann-La Roche | Not recruiting | 18 Years | 80 Years | All | 359 | Phase 3 | United States;Brazil;Canada;Czechia;Denmark;Germany;Hungary;India;Israel;Italy;Mexico;Poland;Slovakia;South Africa;Ukraine;Czech Republic | |
| 399 | NCT02209987 | August 2014 | 19 February 2015 | Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Adults | A Phase 1 Study to Evaluate the Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Subjects | Ulcerative Colitis | Drug: GS-5745 SC;Drug: GS-5745 IV | Gilead Sciences | Not recruiting | 18 Years | 45 Years | Both | 28 | Phase 1 | New Zealand | |
| 400 | JPRN-JapicCTI-142648 | 22/7/2014 | 16 July 2019 | Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects with Moderate to Severe Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis [M14-033] | Ulcerative Colitis | Intervention name : adalimumab INN of the intervention : adalimumab Dosage And administration of the intervention : subcutaneous injection Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : subcutaneous injection | AbbVie GK | Not Recruiting | 18 | 75 | BOTH | 100 | Phase 3 | Japan, North America, Europe | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 401 | EUCTR2013-000891-13-DE | 21/07/2014 | 12 October 2015 | Study with the herbal preparation STW5-II in patients with mild to moderate ulcerative colitis (chronic inflammatory bowel disease) | A randomised, double-blind, placebo-controlled multi-centre study to investigate the effectiveness and safety of STW5-II as add-on treatment for induction of remission in patients with mild to moderate ulcerative colitits | Ulcerative colitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Iberogast N Product Name: Iberogast N Product Code: STW5-II Pharmaceutical Form: Oral drops, liquid INN or Proposed INN: Bitterschleifenblume-ganzpflanze 1,5ml/10ml Other descriptive name: BITTER CANDYTUFT FRESH PLANT EXTRACT Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 15- INN or Proposed INN: Kümmel 2ml/10ml Other descriptive name: CARVI EXTRACTUM FLUIDUM Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 20- INN or Proposed INN: Pfefferminzblätter 1ml/10ml Other descriptive name: MENTHA × PIPERITA L. FOLIUM Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 10- INN or Proposed INN: Süßholzwurzel 1ml/10ml Other descriptive name: GLYCYRRHIZA GLABRA ROOT Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 10- INN or Proposed INN: Kamillenblüten 3ml/10ml Other descriptive name: MATRICARIA RECUTITA L. FLOS Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 30- INN or Proposed INN: Melissenblätter 15ml/10ml Other descriptive name: MELISSAE FOLII DRY AQUEOUS EXTRACT Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 15- Pharmaceutical form of the placebo: Oral drops, liquid Route of administration of the placebo: Oral use | Steigerwald Arzneimittelwerk GmbH | Not Recruiting | Female: yes Male: yes | Germany | |||||
| 402 | NCT02049502 | July 2014 | 1 April 2019 | FMT in Ulcerative Colitis-Associated Pouchitis | The Use of Fecal Microbiota Transplantation in Patients With Ulcerative Colitis-associated Pouchitis | Ulcerative Colitis Associated Pouchitis | Biological: biologically active human fecal microbiota;Procedure: sigmoidoscopy | Virginia O. Shaffer | Not recruiting | 18 Years | 65 Years | All | 8 | Phase 2 | United States | |
| 403 | NCT02227342 | July 2014 | 9 January 2017 | Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis | A Prospective, Single Center, Open Label Trial of Fecal Microbiota Transplantation (FMT) in the Management of Active Ulcerative Colitis | Ulcerative Colitis | Biological: Fecal Microbiota Transplant | University of Alberta | Not recruiting | 18 Years | 65 Years | Both | 3 | Phase 1/Phase 2 | Canada | |
| 404 | JPRN-UMIN000014275 | 2014/06/24 | 2 April 2019 | Efficacy of infliximab for refractory pouchitis with complexed anal fistula | ulcerative colitis | infliximab | Hyogo College of Medicine | Not Recruiting | Not applicable | Not applicable | Male and Female | 10 | Phase 1 | Japan | ||
| 405 | EUCTR2014-000656-29-BE | 13/06/2014 | 24 November 2014 | Study to evaluate delivery preference of Simponi (golimumab) by Ulcerative Colitis patients: delivery using a prefilled syringe or the Smartject™ device | Preference for a prefilled syringe or Smartject™ device for delivering SIMPONI (golimumab) in patients suffering from moderate to severe ulcerative colitis - SMART | Ulcerative Colitis MedDRA version: 17.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: Simponi® (Golimumab) Product Name: Simponi (Golimumab) Product Code: MK-8259 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: GOLIMUMAB CAS Number: 476181-74-5 Current Sponsor code: MK-8259 Other descriptive name: Simponi Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Trade Name: Simponi® (Golimumab) Product Name: Simponi (Golimumab) Product Code: MK-8259 Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: GOLIMUMAB CAS Number: 476181-74-5 Current Sponsor code: MK-8259 Other descriptive name: Simponi Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- | MSD Belgium BVBA/SPRL | Authorised | Female: yes Male: yes | Belgium | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 406 | JPRN-UMIN000014152 | 2014/06/04 | 2 April 2019 | A trial of a combination therapy of fecal microbiota transplantation and antibiotics or simple fecal microbiota therapy for ulcerative colitis | ulcerative colitis | Administration of the fecal material from healthy donors to patients after taking three kinds of antibiotics (Amoxicillin, fosmycin, metronidazole) for two weeks | Juntendo university school of medicine Department of gastroenterology | Recruiting | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan | ||
| 407 | JPRN-UMIN000013546 | 2014/06/01 | 2 April 2019 | The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus | rheumatoid arthritis, lupus nephritis, polymyositis/dermatomyositis with interstitial pneumonia, ulcerative colitis | take a glass of grapefruit juice every day do not take grapefruit juice | Department of Rheumatology and Clinical Immunology, Kyoto University Hospital | Not Recruiting | 16years-old | 80years-old | Male and Female | 20 | Not applicable | Japan | ||
| 408 | NCT02179372 | June 2014 | 12 December 2016 | Eicosapentaenoic Free Fatty Acid and Fecal Calprotectin in Inflammatory Bowel Diseases | Modulation of Fecal Calprotectin by Eicosapentaenoic Free Fatty Acid in Inflammatory Bowel Diseases | Ulcerative Colitis;Crohn's Disease | Dietary Supplement: Eicosapentaenoic acid;Dietary Supplement: Medium chain fatty acid (placebo) | Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi | Not recruiting | 18 Years | 80 Years | Both | 60 | N/A | Italy | |
| 409 | NCT02186886 | June 2014 | 19 February 2015 | Physiological Intermolecular Modification Spectroscopy (PIMS) in Ulcerative Colitis With Golimumab | Personalised Medicine: a Break Through Approach for Early Determination of Anti Tumor Necrosis Factor (TNF) Responders and Non Responders Among Patients With Ulcerative Colitis in a Prospective Study With Golimumab (Simponi) | Ulcerative Colitis | Drug: Golimumab | Kliniken im Naturpark Altmuehltal | Recruiting | 18 Years | N/A | Both | 50 | Phase 4 | Germany | |
| 410 | NCT02100696 | May 21, 2014 | 4 November 2019 | A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors | Phase III, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Etrolizumab During Induction and Maintenance in Patients With Moderate to Severe Active Ulcerative Colitis Who Have Been Previously Exposed to TNF Inhibitors | Ulcerative Colitis | Drug: Etrozulimab;Drug: Placebo | Hoffmann-La Roche | Not recruiting | 18 Years | 80 Years | All | 609 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Korea, Republic of;Lithuania;Mexico;Netherlands;Poland;Romania;Spain;Switzerland;United Kingdom;Czech Republic;New Zealand | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 411 | ChiCTR-OCH-14004615 | 2014-05-12 | 18 April 2017 | Prospective cohort study of Qing Chang Wen Zhong decoction in the treatment of patients with mild and moderate ulcerative colitis. | Prospective cohort study of qingchangwenzhong decoction in the treatment of patients with mild and moderate ulcerative colitis. | ulcerative colitis | clinical group:Qing Chang Wen Zhong decoction;control:Mesalazine Enteric-coated Tablets or Medichemie Ettingen; | Dongfang Hospital Affiliated to Beijing University of Traditional Chinese Medicine | Not Recruiting | 18 | 65 | Both | clinical group:60;control:60; | Other | China | |
| 412 | EUCTR2012-003702-27-DE | 08/05/2014 | 11 December 2017 | LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis | Randomized, double-blind, double-dummy, placebo-controlled, Phase III clinical trial on the efficacy and safety of a 12-weeks add-on treatment with LT-02 (gastro-resistant phosphatidylcholine granules) vs. placebo in patients with ulcerative colitis refractory to standard treatment with mesalamine - Phosphatidylcholine (LT-02) vs. placebo for induction of remission in mesalamine-refractory UC | Acute Ulcerative Colitis (UC) MedDRA version: 19.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: gastro-resistant phosphatidylcholine granules Product Code: LT-02 Pharmaceutical Form: Gastro-resistant granules INN or Proposed INN: Phosphatidylcholine CAS Number: 97281-47-5 Current Sponsor code: LT-02 Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 800- Pharmaceutical form of the placebo: Gastro-resistant granules Route of administration of the placebo: Oral use | Dr. Falk Pharma GmbH | Not Recruiting | Female: yes Male: yes | 762 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Germany;Latvia;Netherlands | |||
| 413 | JPRN-UMIN000013694 | 2014/05/01 | 2 April 2019 | Individualized tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs | ulcerative colitis | determine CYP3A5 SNP status increase the initial dosage of tacrolimus | Kitasato University Kitasato Institute Hospital | Recruiting | 18years-old | Not applicable | Male and Female | 30 | Not selected | Japan | ||
| 414 | EUCTR2013-004599-36-DE | 23/04/2014 | 30 October 2017 | SB012 for the treatment of active ulcerative colitis: a clinical study in early development (phase IIa), conducted in several study centres, with random assignment of patients to active treatment or placebo, to investigate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once daily | SB012 for the treatment of active ulcerative colitis (SECURE): a prospective, multi-centre, randomised, double-blind, placebo-controlled phase IIa clinical trial to evaluate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once daily - SECURE | Active ulcerative colitis;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: SB012 Pharmaceutical Form: Enema INN or Proposed INN: hgd40 Current Sponsor code: hgd40 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 7.5- Pharmaceutical form of the placebo: Enema Route of administration of the placebo: Rectal use | sterna biologicals GmbH & Co. KG | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Germany | |||
| 415 | JPRN-UMIN000013716 | 2014/04/15 | 2 April 2019 | A study of infliximab administration method for tacrolimus-resistant active ulcerative colitis | ulcerative colitis | After administrating tacrolimus and infliximab for 6 weeks,tacrolimus is tapered to 0mg. Infliximab monotherapy | Yokohama City University Medical Center | Not Recruiting | 16years-old | Not applicable | Male and Female | 40 | Phase 2 | Japan | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 416 | EUCTR2013-005013-13-LT | 08/04/2014 | 16 November 2015 | A Study Comparing SB5 to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy | Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB5 is rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), adult Crohn's disease (CD), paediatric CD, ankylosing spondylitis (AS), psoriasis (Ps), psoriatic arthritis (PsA), ulcerative colitis (UC), and psoriasis. MedDRA version: 16.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SB5 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Current Sponsor code: SB5 Other descriptive name: SB5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Trade Name: Humira® Product Name: Humira® Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Current Sponsor code: not applicable Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- | Samsung Bioepis Co., Ltd. | Not Recruiting | Female: yes Male: yes | 490 | Czech Republic;Mexico;Poland;Ukraine;Lithuania;Russian Federation;Bulgaria;United Kingdom;Korea, Republic of;Bosnia and Herzegovina | ||||
| 417 | ChiCTR-IOR-15006812 | 2014-04-01 | 18 April 2017 | Effect of dispelling wind and eliminating dampness therapy in mucosal healing of ulcerative colitis | Effect of dispelling wind and eliminating dampness therapy in mucosal healing of ulcerative colitis | ulcerative colitis | intervetion group:wind-dispelling and damp-eliminating glanules;control group:Mesalazine; | Department of anorectal surgery, Dongzhimen Hospital, Beijing University of Chinese Medicine | Recruiting | 18 | 70 | Both | intervetion group:30;control group:30; | Other | China | |
| 418 | NCT01960426 | April 2014 | 23 May 2016 | Evaluation of Health Costs and Resource Utilization | A Randomized Evaluation of Health Costs and Resource Utilization Comparing Testing-Based Therapy to Empiric Dose Intensification for the Management of Inflammatory Bowel Disease. | Ulcerative Colitis;Crohn's Disease | Other: Measurement of drug (Adalimumab/Infliximab);Other: Intensify treatment with the existing drug | University of Western Ontario, Canada | Prometheus Laboratories | Not recruiting | 18 Years | N/A | Both | 51 | Phase 4 | United States |
| 419 | NCT02129439 | April 2014 | 11 June 2018 | Efficacy, Pharmacokinetics, Tolerability, Safety of SB012 Intrarectally Applied in Active Ulcerative Colitis Patients | SB012 for Treatment of Active Ulcerative Colitis: Prospective Multi-centre Randomised Double-blind Placebo-controlled Phase IIa Clinical Trial to Evaluate Efficacy, Pharmacokinetics, Tolerability and Safety of SB012 Enema Administered OD | Colitis, Ulcerative | Drug: SB012;Drug: Placebo | Sterna Biologicals GmbH & Co. KG | Not recruiting | 18 Years | 75 Years | All | 20 | Phase 1/Phase 2 | Germany | |
| 420 | NCT02913508 | April 2014 | 3 October 2016 | Vedolizumab Subcutaneous (SC) Versus Intravenous (IV) in Ulcerative Colitis or Crohn's Disease | A Randomized, Open Label Phase 2 Study to Assess Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety and Exploratory Efficacy of Vedolizumab Subcutaneous Compared to Vedolizumab Intravenous in Subjects With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Vedolizumab subcutaneous injection;Drug: Vedolizumab intravenous injection | Takeda | Not recruiting | 18 Years | 80 Years | Both | 0 | Phase 2 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 421 | NCT02065622 | March 27, 2014 | 28 October 2019 | Study to Evaluate the Safety and Efficacy of Two Drug Regimens in Subjects With Moderate to Severe Ulcerative Colitis | A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis (UC) | Drug: Adalimumab;Other: Placebo | AbbVie | Not recruiting | 18 Years | 75 Years | All | 952 | Phase 3 | United States;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Hungary;Israel;Italy;Japan;Netherlands;Poland;Romania;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;Czech Republic | |
| 422 | JPRN-UMIN000014205 | 2014/03/25 | 16 July 2019 | Examination of the medical treatment by the pancrelipase to the refractory inflammatory bowel disease patient | Examination of the medical treatment by the pancrelipase to the refractory inflammatory bowel disease patient - Validity of pancrelipase in patients with inflammatory bowel disease | Crohn's disease Ulcerative colitis | Administration of pancrelipase | Department of Gastroenterology Osaka City University Graduate School of Medicine | Not Recruiting | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan | |
| 423 | EUCTR2013-003060-31-LV | 17/02/2014 | 7 October 2014 | A Placebo Controlled Trial of HMPL-004 in Subjects with Mild to Moderate Active Ulcerative Colitis | A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects with Mild to Moderate Ulcerative Colitis with Clinical Remission or Response from Induction Therapy. (NATRUL-4) | Ulcerative Colitis (UC) MedDRA version: 17.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: HMPL-004 Pharmaceutical Form: Tablet CAS Number: 8000051-24-3 Current Sponsor code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- CAS Number: 5508-58-7 Other descriptive name: AND (Andrographolide) CAS Number: 27215-14-1 Other descriptive name: NAND (Neoandrographolide) CAS Number: 4176-97-0 Other descriptive name: DAND (14-Deoxyandrographolide) CAS Number: 42895-58-9 Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) CAS Number: 327-97-9 Other descriptive name: CLA (Chlorogenic acid) CAS Number: 29741-09-1 Other descriptive name: AODG (Apigenin-7-O-glucuronide) Product Code: HMPL-004 Pharmaceutical Form: Tablet CAS Number: 8000051-24-3 Current Sponsor code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600- CAS Number: 5508-58-7 Other descriptive name: AND (Andrographolide) CAS Number: 27215-14-1 Other descriptive name: NAND (Neoandrographolide) CAS Number: 4176-97-0 Other descriptive name: DAND (14-Deoxyandrographolide) CAS Number: 42895-58-9 Other descriptive name: DDAND (14-deoxy-11,12-didehydroandrographolide) CAS Number: 327-97-9 Other descriptive name: CLA (Chlorogenic acid) CAS Number: 29741-09-1 Other descriptive name: AODG (Apigenin-7-O-glucuronide) Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Nutrition Science Partners Limited | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Czech Republic;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 424 | JPRN-JapicCTI-142403 | 04/2/2014 | 16 July 2019 | Phase 3 study of MLN0002 (300 mg) in treatment of ulcerative colitis | Phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and pharmacokinetics of intravenous MLN0002 (300 mg) infusion in induction and maintenance therapy in Japanese subjects with moderate or severe ulcerative colitis | Ulcerative colitis | Intervention name : MLN0002 (Vedolizumab) INN of the intervention : Vedolizumab Dosage And administration of the intervention : Induction Phase: Cohort 1/Cohort 2: Vedolizumab 300 mg; Vedolizumab 300 mg, IV intravenous (IV) infusion, once at Weeks 0, 2, and 6 in the induction phase. Intervention name : MLN0002 (Vedolizumab) INN of the intervention : Vedolizumab Dosage And administration of the intervention : Maintenance Phase: Vedolizumab 300 mg; Vedolizumab 300 mg, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive vedolizumab in maintenance phase. Intervention name : MLN0002 (Vedolizumab) INN of the intervention : Vedolizumab Dosage And administration of the intervention : Maintenance Phase: Placebo; Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved clinical response at Week 10 and were randomized to receive placebo in maintenance phase. Intervention name : MLN0002 (Vedolizumab) INN of the intervention : Vedolizumab Dosage And administration of the intervention : Open-Label Cohort: Vedolizumab 300 mg Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 in open-label cohort. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Induction Phase: Cohort 1, Placebo; Vedolizumab placebo-matching, IV infusion, once at Weeks 0, 2 and 6 in the induction phase. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Maintenance Phase: Placebo continuation Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in | TAKEDA PHARMACEUTICAL COMPANY LTD. | Not Recruiting | 15 | 80 | BOTH | 292 | Phase 3 | Japan | |
| 425 | NCT02039505 | February 4, 2014 | 8 April 2019 | Phase III Study of MLN0002 (300 mg) in the Treatment of Ulcerative Colitis | Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Induction and Maintenance Therapy in Japanese Subjects With Moderate or Severe Ulcerative Colitis | Ulcerative Colitis | Drug: Vedolizumab;Drug: Vedolizumab placebo | Takeda | Not recruiting | 15 Years | 80 Years | All | 292 | Phase 3 | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 426 | JPRN-UMIN000013033 | 2014/02/01 | 2 April 2019 | Examination of the early clinical and endoscopic views change after infliximab administration in the ulcerative colitis. | Ulcerative colitis | Study start - 14 weeks:5mg/kg of Infliximab for 0.2.6.14 week, respectively ( initial administration day with 0 weeks) | Department of Internal Medicine,Juntendo University | Not Recruiting | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan | ||
| 427 | NCT01765439 | February 2014 | 20 August 2018 | The Effect of VSL#3 Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammatory Bowel Disease | The Effect of VSL#3 (Original De Simone Formulation) Probiotic Preparation on the Bile Acid Metabolism in Patients With Inflammatory Bowel Disease | Crohn Disease;Ulcerative Colitis | Dietary Supplement: VSL#3 (Original De Simone formulation) | Charles University, Czech Republic | Iscare i.v.f., Czech Republic;CD Investments srl;University Of Perugia;University of Roma La Sapienza | Recruiting | N/A | N/A | All | 80 | N/A | Czechia;Czech Republic |
| 428 | NCT01947101 | February 2014 | 20 June 2016 | Fecal Microbiota Transplantation (FMT) for Treatment of Ulcerative Colitis in Children | A Phase I Study of Fecal Microbiota Transplantation (FMT) in Immunomodulator Dependent Pediatric Ulcerative Colitis (UC) | Ulcerative Colitis | Biological: Fecal Microbiota Transplant | Baylor College of Medicine | Not recruiting | 12 Years | 20 Years | Both | 6 | Phase 1 | United States | |
| 429 | EUCTR2013-004583-56-GB | 28/01/2014 | 3 April 2017 | Go-colitis: Golimumab: A Phase 4 UK Study on its Utilisation and Impact in Ulcerative Colitis | Golimumab: A Phase 4, UK Open Label, Single arm Study on its Utilization and Impact in Ulcerative Colitis - Go-colitis | Ulcerative colitis MedDRA version: 16.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Simponi Product Name: Simponi Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: golimumab CAS Number: 476181-74-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50-200 | MSD | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | United Kingdom | |||
| 430 | NCT01988506 | January 6, 2014 | 27 August 2018 | Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases | Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach | Rheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic Sclerosis | Drug: Interleukin 2 | Assistance Publique - Hôpitaux de Paris | Iltoo Pharma | Recruiting | 18 Years | N/A | All | 132 | Phase 2 | France |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 431 | NCT02033408 | January 2014 | 23 April 2019 | Manipulating the Microbiome in IBD by Antibiotics and FMT | Manipulating the Microbiome in IBD by Antibiotics and Fecal Microbiota Transplantation (FMT): a Randomized Controlled Trial | Exacerbation of Ulcerative Colitis;Ulcerative Colitis, Active Severe;Crohn's Colitis | Drug: AB (antibiotics);Drug: CS (corticosteroids) Only | Shaare Zedek Medical Center | Not recruiting | 2 Years | 75 Years | All | 28 | Phase 4 | Canada;Finland;Israel;Italy;Poland;Spain | |
| 432 | NCT02069561 | January 2014 | 28 September 2015 | Effects of Eicosapentaenoic Acid on Subjects at High Risk for Colorectal Cancer | Effects of Eicosapentaenoic Acid on Molecular, Metabonomics and Intestinal Microbiota Changes, in Subjects With Long-standing Inflammatory Bowel Disease | Ulcerative Colitis | Dietary Supplement: Eicosapentaenoic Acid | Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi | Not recruiting | 18 Years | 70 Years | Both | 25 | N/A | Italy | |
| 433 | JPRN-JapicCTI-142475 | 24/12/2013 | 2 April 2019 | Phase 3 Clinical Trial with MD-0901 | Phase 3 Clinical Trial with MD-0901 | Mild to moderate active ulcerative colitis | Intervention name : MD-0901 INN of the intervention : Mesalazine Dosage And administration of the intervention : Mesalazine 4.8 g/d are administrated orally once daily after breakfast for 8 weeks. Control intervention name : Asacol tablet INN of the control intervention : Mesalazine Dosage And administration of the control intervention : Mesalazine 3.6 g/d are administrated orally 3 times daily after each meal for 8 weeks. | MOCHIDA PHARMACEUTICAL CO., LTD. | 16 | BOTH | 250 | Phase 3 | ||||
| 434 | NCT02000453 | December 20, 2013 | 16 December 2017 | Safety and Tolerability Study of GSK2586184 in Patients With Moderate to Severely Active Ulcerative Colitis. | An Open Label, Experimental Medicine Investigation of the Safety and Tolerability of 400 mg b.i.d. GSK2586184 in Patients With Moderate to Severely Active Ulcerative Colitis. | Colitis, Ulcerative | Drug: GSK2586184 400mg | GlaxoSmithKline | Prof Geert D'Haens, AMC, Amsterdam | Not recruiting | 18 Years | 75 Years | All | 2 | Phase 1 | Netherlands |
| 435 | EUCTR2011-001332-29-AT | 02/12/2013 | 27 October 2014 | The degradation and elimination of Infliximab | Pharmacokinetics of Infliximab | Inflammatory bowel disease (Ulcerative Colitis, Crohn's disease) MedDRA version: 17.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 17.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: Remicade Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Other descriptive name: Remicade Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie | Authorised | Female: yes Male: yes | Austria | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 436 | JPRN-UMIN000004201 | 2013/12/02 | 2 April 2019 | The evaluation of efficacy for remission maintenance with immunomodulator following remission induction with tacrolimus in patients with moderate to severe active refractory ulcerative colitis.:mucosal healing for prognosis | The patients with moderate to severe active refractory ulcerative colitis | Group of remission maintenance therapy for 48 weeks with immunomodulator at from 2 to 4 weeks following remission induction with tacrolimus, Group of no remission maintenance therapy with immunomodulator following remission induction with tacrolimus, | Osaka City University, Graduate School of Medicine,Department of Gastroenterology | Not Recruiting | 16years-old | 65years-old | Male and Female | 50 | Not selected | Japan | ||
| 437 | NCT01988961 | December 2013 | 16 December 2017 | A Study to Evaluate the Accuracy of a Subset of the Length-109 Probe Set Panel (a Genetic Test) in Predicting Response to Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2a Open-Label Study to Evaluate Prediction of Response to Golimumab Using a Transcriptomic Profile in Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Biological: Golimumab | Janssen Research & Development, LLC | Not recruiting | 18 Years | N/A | All | 103 | Phase 2 | United States;Belgium;Bulgaria;Canada;Czech Republic;France;Germany;Hungary;Netherlands;Poland;Russian Federation;Ukraine | |
| 438 | NCT01959165 | November 21, 2013 | 11 June 2018 | MEDI7183 Phase 2 Study in Japanese Ulcerative Colitis Patients | Ulcerative Colitis | Drug: MEDI7183 low dose;Drug: MEDI7183 medium dose;Drug: MEDI7183 high dose;Drug: Matching Placebo | AstraZeneca | Not recruiting | 18 Years | 65 Years | All | 44 | Phase 2 | Japan | ||
| 439 | NCT01959282 | November 15, 2013 | 14 January 2019 | A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis | A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-response Study Evaluating the Efficacy and Safety of JNJ-54781532 in Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Placebo;Drug: JNJ-54781532 25 mg once daily;Drug: JNJ-54781532 75 mg once daily;Drug: JNJ-54781532 150 mg once daily;Drug: JNJ-54781532 75 mg twice daily | Janssen Research & Development, LLC | Not recruiting | 18 Years | N/A | All | 219 | Phase 2 | United States;Australia;Belgium;Bulgaria;Canada;France;Germany;Hungary;Israel;Netherlands;Poland;Romania;Russian Federation;Ukraine | |
| 440 | NCT01896635 | November 2013 | 7 November 2016 | Faecal Microbiota Transplantation in Ulcerative Colitis | Faecal Microbiota Transplantation for Chronic Active Ulcerative Colitis - A Randomised Double Blind Controlled Study of Efficacy & Safety | Ulcerative Colitis;Inflammatory Bowel Disease | Biological: FMT infusions;Other: Placebo infusion | The University of New South Wales | Not recruiting | 18 Years | 75 Years | Both | 81 | Phase 2 | Australia | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 441 | NCT01953354 | November 2013 | 16 December 2017 | Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis | A Prospective, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study of Trichuris Suis Ova Treatment in Left-sided Ulcerative Colitis and Its Effects on Mucosal Immune State and Microbiota | Colitis, Ulcerative | Biological: Trichuris suis ova (TSO);Biological: Placebo | National Institute of Allergy and Infectious Diseases (NIAID) | Coronado Biosciences, Inc.;Autoimmunity Centers of Excellence | Not recruiting | 18 Years | 70 Years | All | 16 | Phase 2 | United States |
| 442 | NCT01971814 | November 2013 | 8 June 2015 | Early Serum Infliximab Levels in Severe Ulcerative Colitis. | Early Serum Infliximab Levels in Severe Ulcerative Colitis | Ulcerative Colitis (UC);Inflammatory Bowel Disease | Drug: Infliximab | University of California, San Francisco | Not recruiting | 18 Years | N/A | Both | 11 | Phase 1 | United States | |
| 443 | NCT03268213 | November 2013 | 11 November 2019 | Fecal Microbial Transplantation for C. Difficile and/or Ulcerative Colitis or Indeterminate Colitis | Fecal Microbial Transplantation in Patients With Medication Refractory Clostridium Difficile and/or Ulcerative Colitis or Indeterminate Colitis | Clostridium Difficile Infection;Ulcerative Colitis;Indeterminate Colitis | Biological: Fecal Microbial Transplantation | Stony Brook University | Not recruiting | 7 Years | N/A | All | 12 | Early Phase 1 | United States | |
| 444 | ChiCTR-TRC-13003530 | 2013-10-01 | 18 April 2017 | Effect of hydrogen rich water on ulcerative colitis: a randomized controlled trial | Effect of hydrogen rich water on ulcerative colitis: a randomized controlled trial | ulcerative colitis | one:hydrogen rich water;two:pure water; | 411th Hospital of PLA | Not Recruiting | 18 | 60 | Both | one:20;two:20; | Pilot study | China | |
| 445 | JPRN-UMIN000010127 | 2013/09/24 | 2 April 2019 | Comparative study for mucosal concentration of 5-ASA by once-daily vs divided dosing of oral mesalazine in quiescent ulcerative colitis | ulcerative colitis | Eligible patients will be treated with 3g of oral mesalazine once daily for at least two weeks Eligible patients will be treated with 3g of oral mesalazine twice daily for at least two weeks Eligible patients will be treated with 3g of oral mesalazine three times daily for at least two weeks | Department of Gastroenterology and Hepatology, Kyoto University Hospital | Not Recruiting | 20years-old | Not applicable | Male and Female | 50 | Not applicable | Japan | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 446 | NCT01941589 | September 2013 | 16 December 2017 | Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis | Combination Corticosteroids + 5-aminosalicylic Acids Compared to Corticosteroids Alone in the Treatment of Moderate-severe Active Ulcerative Colitis. | Ulcerative Colitis | Drug: oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone;Drug: corticosteroids only | Sheba Medical Center | Recruiting | 18 Years | N/A | All | 160 | Phase 4 | China;France;Greece;Israel;Italy;Korea, Republic of;Serbia | |
| 447 | NCT02306798 | September 2013 | 19 February 2015 | TP0502-B-Pharmaco-Scintigraphic-Study | An Open Label, Single-site Pharmaco-Scintigraphic Study in Healthy Subjects With Radio-labelled TP05-tablets (Mesalazine) to Evaluate the Gastrointestinal Transit and Release Profile | Ulcerative Colitis | Drug: TP05 | Tillotts Pharma AG | Not recruiting | 18 Years | 55 Years | Both | 9 | Phase 1 | ||
| 448 | NCT01900574 | August 9, 2013 | 16 September 2019 | A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFa Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFa Antibody, in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Golimumab | Janssen Research & Development, LLC | Not recruiting | 2 Years | 17 Years | All | 35 | Phase 1 | United States;Austria;Belgium;Canada;Denmark;France;Germany;Israel;Netherlands;Poland | |
| 449 | NCT01929668 | August 2013 | 9 May 2016 | Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Inactive UC Patients | Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Patients With Inactive Ulcerative Colitis; Randomized, Single Blind, Multicenter Study | Ulcerative Colitis | Drug: polyethylene glycol;Drug: Ascorbic Acid | Kyungpook National University | Not recruiting | 18 Years | 80 Years | Both | 114 | N/A | Korea, Republic of | |
| 450 | NCT02144350 | August 2013 | 11 June 2018 | Hyperbaric Oxygen for Ulcerative Colitis | Hyperbaric Oxygen Therapy for Moderate to Severe Ulcerative Colitis Flares: A Multi-center Randomized Double Blind Sham Controlled Trial | Ulcerative Colitis | Procedure: Hyperbaric oxygen;Procedure: Sham Hyperbaric Air | Dartmouth-Hitchcock Medical Center | Mayo Clinic;University of Pittsburgh | Not recruiting | 18 Years | N/A | All | 18 | Phase 2/Phase 3 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 451 | NCT02267694 | August 2013 | 16 December 2017 | Study of Freeze-dried Black Raspberry in Maintenance of Ulcerative Colitis | A Trial of Freeze-dried Black Raspberry in Maintenance of Remission of Ulcerative Colitis | Ulcerative Colitis | Drug: Freeze-dried black raspberry powder | UConn Health | Medical College of Wisconsin | Not recruiting | 18 Years | 90 Years | All | 7 | Phase 1 | United States |
| 452 | EUCTR2012-004366-18-AT | 30/07/2013 | 6 October 2015 | A Study to Assess the Safety and Pharmacokinetics (Serum Levels) of Golimumab in Children With Moderately to Severely Active Ulcerative Colitis | A Phase 1b Open-Label Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human anti-TNFa Antibody, in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis - PURSUIT PEDS PK | Ulcerative Colitis in pediatric subjects MedDRA version: 18.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Golimumab Product Code: CNTO148 Pharmaceutical Form: Solution for injection INN or Proposed INN: Golimumab CAS Number: 476181-74-5 Current Sponsor code: CNTO148 Other descriptive name: Human anti-TNF-alpha monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- | Janssen Biologics B.V. | Authorised | Female: yes Male: yes | 30 | Phase 1b | France;United States;Canada;Poland;Belgium;Denmark;Austria;Israel;Netherlands;Germany | |||
| 453 | EUCTR2012-001653-13-IT | 10/07/2013 | 10 March 2014 | New Therapeutic Strategy in Ulcerative Colitis | New Therapeutic Options for the Maintenance of Remission of the Ulcerative Colitis in Pediatric Patients | Ulcerative Colitis MedDRA version: 15.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: AZAFOR 50mg Product Name: AZATIOPRINA Product Code: AZA Pharmaceutical Form: Tablet INN or Proposed INN: AZATHIOPRINE CAS Number: 446-86-6 Current Sponsor code: AZA Other descriptive name: AZATHIOPRINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Dipartimento di Pediatria Università Federico II di Napoli | Authorised | Female: yes Male: yes | 130 | Italy | ||||
| 454 | NCT01861249 | July 2013 | 8 August 2016 | Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | A Multicenter Single-Arm Open Label Extension Study Evaluating The Long Term Safety And Tolerability Of SAR339658 In Patients With Ulcerative Colitis (UC) | Ulcerative Colitis | Drug: SAR339658 | Sanofi | Not recruiting | 18 Years | N/A | Both | 6 | Phase 2 | United States;Canada | |
| 455 | NCT01903252 | July 2013 | 20 August 2018 | TP05 for the Treatment of Mild to Moderate Active Ulcerative Colitis (UC) | A Randomised, Active-Controlled, Double-Blind and Open Label Extensions Study to Evaluate the Efficacy, Long-Term Safety and Tolerability of TP05 3.2g/Day for the Treatment of Active Ulcerative Colitis | Acute Ulcerative Colitis | Drug: TP05;Drug: Asacol 400 mg | Tillotts Pharma AG | Not recruiting | 18 Years | N/A | All | 817 | Phase 3 | Switzerland;Netherlands | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 456 | EUCTR2013-000366-11-SE | 28/06/2013 | 29 August 2016 | Study to test whether TP05 at a dose of 3.2 g/day is safe, well-tolerated and works as a treatment for active Ulcerative Colitis. Treatment will be assigned by chance and patients and investigators will not know whether the patients are receiving TP05 or the standard therapy. This blinded period will be followed by a period where all patients receive TP05. | A Randomised Active-Controlled Double-Blind and Open Label Extension Study to Evaluate the Efficacy, Long-term Safety and Tolerability of TP05 3.2 g/day for the Treatment of Active Ulcerative Colitis (UC) | Ulcerative colitis MedDRA version: 17.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: MESALAZINE CAS Number: 89-57-6 Current Sponsor code: TP05 Concentration unit: g gram(s) Concentration type: up to Concentration number: 4.8- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Asacol Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: MESALAZINE CAS Number: 89-57-6 Concentration unit: g gram(s) Concentration type: up to Concentration number: 4.8- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Tillotts Pharma AG | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | |||
| 457 | EUCTR2012-004768-23-DE | 12/06/2013 | 16 August 2016 | A Phase 2a Trial of STNM01 by a Single Submucosal Injection to Investigate the Mucosal Healing Efficacy in Patients with Ulcerative Colitis | A Phase 2a Trial of STNM01 by a Single Submucosal Injection to Investigate the Mucosal Healing Efficacy in Patients with Ulcerative Colitis | Ulcerative Colitis with active endoscopic lesion(s), ranging in severity from moderate to severe in endoscopic score not responding sufficiently to conventional treatment MedDRA version: 19.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: STNM01 1.84 mg Product Code: STNM01 Pharmaceutical Form: Lyophilisate for solution for injection INN or Proposed INN: STNM01 Current Sponsor code: STNM01 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.84- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Submucosal use | STELIC INSTITUTE & CO. | Not Recruiting | Female: yes Male: yes | Phase 2 | Germany | ||||
| 458 | JPRN-UMIN000010906 | 2013/06/10 | 2 April 2019 | The exploratory randomized controlled trial by high-dose Asacol treatment to patients with ulcerative colitis aiming to maintain remission. | Ulcerative Colitis | A 24-week administration of 4.8g/day of Asacol A 24-week administration of the mesalazine which the patients have taken before the treatment of 4.8g/day of Asacol as induction therapy | Chiba University Hospital | Not Recruiting | 15years-old | 70years-old | Male and Female | 60 | Phase 2 | Japan | ||
| 459 | JPRN-UMIN000013370 | 2013/06/07 | 2 April 2019 | Efficacy of infliximab therapy for refractory pouchitis | ulcerative colitis, pouchitis | infliximab | Inflammatory bowel disease center, Hyogo college of medicine | Not Recruiting | 18years-old | 80years-old | Male and Female | 10 | Phase 1 | Japan | ||
| 460 | JPRN-UMIN000013371 | 2013/06/05 | 2 April 2019 | Efficacy of infliximab therapy for arthritis after restorative proctocolectomy in patients with ulcerative colitis | ulcerative colitis | infliximab | Hyogo college of medicine | Not Recruiting | 20years-old | 80years-old | Male and Female | 10 | Not selected | Japan | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 461 | JPRN-UMIN000010776 | 2013/06/01 | 2 April 2019 | An open label randomized controlled trial of tacrolimus versus cyclosporine treatment for severe ulcerative colitis | Ulcerative colitis | tacrolimus (Prograf) cyclosporine (Sandimmune) | Chiba University Hospital | Recruiting | 16years-old | 65years-old | Male and Female | 40 | Not selected | Japan | ||
| 462 | NCT01716039 | June 2013 | 5 November 2018 | Pharmacokinetics of Adalimumab With Methotrexate for Treatment of Patients With Ulcerative Colitis (UC) | A Study to Evaluate the Pharmacokinetics of Adalimumab in Combination With Methotrexate for the Treatment of Patients With Ulcerative Colitis | Ulcerative Colitis | Drug: MTX 12.5;Drug: MTX 25;Drug: Adalimumab | University of Western Ontario, Canada | Abbott | Not recruiting | 18 Years | N/A | All | 25 | Phase 4 | |
| 463 | NCT01882764 | June 2013 | 11 March 2019 | HMPL-004 Maintenance Treatment in Subjects With Mild to Moderate Ulcerative Colitis | A Phase III Double Blind, Multi-Center Placebo Controlled Maintenance Trial of HMPL-004 in Subjects With Mild to Moderate Ulcerative Colitis With Clinical Remission or Response From Induction Therapy. (NATRUL-4) | Ulcerative Colitis | Drug: HMPL-004;Drug: Placebo | Hutchison Medipharma Limited | Nutrition Science Partners Limited | Not recruiting | 18 Years | N/A | All | 1 | Phase 3 | United States |
| 464 | NCT02058524 | June 2013 | 5 September 2016 | A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis | A Pilot and Feasibility Study of Fecal Microbiota Transplantation for Ulcerative Colitis | Ulcerative Colitis | Biological: fecal microbiota transplantation | University of Chicago | Not recruiting | 18 Years | 65 Years | Both | 1 | Phase 1 | United States | |
| 465 | JPRN-JapicCTI-132135 | 01/5/2013 | 2 April 2019 | Phase III Study of Z-206 | Phase III Study of Z-206 | Ulcerative Colitis | Intervention name : Z-206 INN of the intervention : Mesalazine Dosage And administration of the intervention : Mesalazine at the dose 2.4g/day is administered once a day or three times a day. Control intervention name : null | Zeria Pharmaceutical Co., Ltd. | Kyowa Hakko Kirin Co., Ltd. | 16 | 64 | BOTH | 600 | Phase 3 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 466 | JPRN-UMIN000010340 | 2013/05/01 | 2 April 2019 | Comparison of rectal with oral mesalazine in the treatment of Ulcerative Proctitis (CORRECT Study) | Ulcerative colitis | Randomized treatment with mesalazine suppository or oral mesalazine for 2 weeks Switch from oral mesalazine to mesalazine suppository for 2 weeks | Saitama Medical Center, Saitama Medical University | Not Recruiting | 18years-old | Not applicable | Male and Female | 60 | Not selected | Japan | ||
| 467 | JPRN-UMIN000010612 | 2013/05/01 | 2 April 2019 | A comparative study of the efficacy of tacrolimus with infliximab in intractable ulcerative colitis | Ulcerative colitis | Tacrolimus will be administered orally for 10 weeks at the trough level of 10-15 ng/ml for the first 2 weeks following that of 5-10 ng/ml for the rest of the study period. Infliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks. | Department of Internal Medicine, Division of Gastroenterology and Hepatology, Keio University School of Medicine | Not Recruiting | 20years-old | Not applicable | Male and Female | 130 | Phase 4 | Japan | ||
| 468 | JPRN-UMIN000013266 | 2013/05/01 | 2 April 2019 | Randomized controlled study comparing 1% of Dermacrin A ointmentwith 0.033% of Guaiazulene ointment for patients with perianal delmatitis after total colectomy | ulcerative colitis, familial adenomatous polyposis | 1% of Dermacrin A ointment 0.033% of Guaiazulene ointment | Mie University Graduate School of Medicine, Gastrointestinal and Pediatric Surgery | Not Recruiting | 20years-old | Not applicable | Male and Female | 30 | Not applicable | Japan | ||
| 469 | NCT02073526 | May 2013 | 9 January 2017 | Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease | Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis | Drug: Infliximab, adalimumab, certolizumab pegol | Oslo University Hospital | Not recruiting | 18 Years | N/A | Both | 1230 | N/A | Norway | |
| 470 | NCT01804166 | March 21, 2013 | 30 September 2019 | A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL) | A Research Study to Bank Samples for Future Evaluation to Identify Biomarkers That Predispose Crohn's Disease and Ulcerative Colitis Patients to Develop Hepatosplenic T-Cell Lymphoma (HSTCL) | Hepatosplenic T-Cell Lymphoma | Drug: Infliximab;Drug: Golimumab | Janssen Scientific Affairs, LLC | Recruiting | N/A | N/A | All | 40 | Phase 4 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 471 | EUCTR2012-005521-73-BE | 20/03/2013 | 21 August 2017 | Placebo-controlled, proof-of-concept oral dose study to explore the safety, pharmacokinetics and pharmacodynamics in subjects with mild to moderate ulcerative colitis | Exploratory, Phase II, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept study to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of GLPG0974 in subjects with mild to moderate Ulcerative Colitis - Proof-of-concept oral dose, safety, tolerability, efficacy, PK and PD study | Mild to moderate Ulcerative Colitis MedDRA version: 16.0 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GLPG0974 Pharmaceutical Form: Capsule INN or Proposed INN: GLPG0974 Current Sponsor code: G279874 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Galapagos NV | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | Czech Republic;Belgium;Latvia | |||
| 472 | NCT01863771 | March 15, 2013 | 16 December 2017 | A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis. | A Phase 3 Multicenter, Placebo-controlled, Double-blind, Randomized-withdrawal Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Golimumab;Other: Placebo | Janssen Pharmaceutical K.K. | Not recruiting | 18 Years | 70 Years | All | 144 | Phase 3 | Japan | |
| 473 | NCT01771809 | March 1, 2013 | 29 January 2018 | Long-Term Safety Of PF-00547659 In Ulcerative Colitis | A Multicenter Open-Label Extension Study To Assess Long-Term Safety Of PF-00547659 In Subjects With Ulcerative Colitis (TURANDOT II) | Ulcerative Colitis | Drug: 75mg PF-00547659;Drug: 225mg PF-00547659 | Shire | Not recruiting | 18 Years | 66 Years | All | 270 | Phase 2 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;Slovakia;South Africa;Spain;Czech Republic;Switzerland | |
| 474 | NCT01805791 | March 2013 | 20 August 2018 | A Phase III Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis | A Phase III, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis | Ulcerative Colitis | Drug: HMPL-004 tablet;Drug: Placebo | Hutchison Medipharma Limited | Not recruiting | 18 Years | 75 Years | All | 201 | Phase 3 | United States | |
| 475 | NCT01810185 | March 2013 | 19 February 2015 | Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease | Low Dose Naltrexone in Symptomatic Inflammatory Bowel Disease | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis | Drug: Low dose naltrexone;Drug: Placebo | Santa Barbara Cottage Hospital | Not recruiting | 18 Years | N/A | Both | 0 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 476 | NCT01831427 | March 2013 | 26 August 2019 | Evaluating the Safety, Pharmacokinetics and Efficacy of GS-5745 in Adults With Moderately to Severely Active Ulcerative Colitis | A Phase 1 Double-blind, Randomized, Placebo-Controlled, Staggered, Single and Multiple Ascending Dose, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: GS-5745;Drug: Placebo to match GS-5745 | Gilead Sciences | Not recruiting | 18 Years | 65 Years | All | 74 | Phase 1 | United States;Belgium;Canada;Hungary;Moldova, Republic of;Netherlands;Romania | |
| 477 | NCT01768858 | February 5, 2013 | 11 February 2019 | Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice | Assessment of Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Crohn's Disease and Ulcerative Colitis Patients´ Adherence Attitudes to Maintenance Therapy With a Scheduled Adalimumab Treatment in Routine Clinical Practice | Crohn´s Disease;Ulcerative Colitis;Plaque Psoriasis;Rheumatoid Arthritis;Ankylosing Spondylitis;Psoriatic Arthritis | Drug: Adalimumab | AbbVie | Raffeiner GmbH | Not recruiting | 18 Years | 99 Years | All | 96 | Phase 2 | Austria |
| 478 | NCT01658605 | February 2013 | 19 February 2015 | A Study to Investigate the Efficacy and Safety of GSK1605786 for Treatment of Patients With Active Ulcerative Colitis | A Phase II, 20-week, Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Proof of Concept Study to Investigate the Efficacy and Safety of GSK1605786 for Treatment of Patients With Active Ulcerative Colitis | Colitis, Ulcerative | Drug: GSK1605786;Other: Placebo | GlaxoSmithKline | Not recruiting | 18 Years | N/A | Both | 0 | Phase 2 | Belgium;Netherlands;United Kingdom | |
| 479 | NCT01759056 | February 2013 | 19 February 2015 | Evaluation of an Oral Anti-TNF Antibody in Patients With Active Ulcerative Colitis | A Multicenter, Double-Blind, Placebo-Controlled, Ascending-Dose, Repeat-Dose Safety and Pharmacokinetic Investigation of a Delayed-Release, Enteric-Coated Capsule Formulation of AVX 470 [Anti-TNF (Tumor Necrosis Factor) Globulin (Bovine)] in Patients With Active Ulcerative Colitis | Ulcerative Colitis | Drug: AVX 470;Drug: Placebo | Avaxia Biologics, Incorporated | Not recruiting | 18 Years | 75 Years | Both | 33 | Phase 1 | United States;Belgium;Canada;Hungary | |
| 480 | JPRN-UMIN000009811 | 2013/01/23 | 2 April 2019 | Comparison of randomized trials of antibiotic combination therapies for patients with ulcerative colitis | Comparison of randomized trials of antibiotic combination therapies for patients with ulcerative colitis - Antibiotics trials for ulcerative colitis | Ulcerative colitis | One group is to receive two-week combination therapy consisting of amoxicillin (Sawacillin) 500 mg t.i.d, tetracycline (Acromycin) 500 mg t.i.d, and metronidazole (Flagyl) 250 mg t.i.d. with an inhibitor of gastric acid secretion. Patients are to be followed for 3 months (first endpoint). Another group will receive two week combination therapy consisting of amoxicillin (Sawacillin) 500 mg t.i.d, fosfomycin (Fosmicin) 1000mg t.i.d, and metrozole (Flagyl) 250 mg t.i.d, with an inhibitor of gastric acid secretion. Patients are to be followed for 3 months. | Division of General Medicine, Department of Internal Medicine, Nihon University School of Medicine | Not Recruiting | 16years-old | 75years-old | Male and Female | 40 | Phase 3 | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 481 | EUCTR2011-001568-22-HU | 15/01/2013 | 29 July 2013 | A placebo-controlled trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis | A multicenter, randomised, double-blind, placebo-controlled, multiple-dose trial with rFXIII administered to subjects with mild to moderate active ulcerative colitis | Mild to moderate Ulcerative Colitis MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Recombinant Factor XIII (rFXIII) Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Catridecacog Current Sponsor code: Recombinant factor XIII (rFXIII) Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 2500- Pharmaceutical form of the placebo: Powder and solvent for solution for injection Route of administration of the placebo: Intravenous use | Novo Nordisk A/S | Not Recruiting | Female: yes Male: yes | 90 | Hungary;European Union;Ukraine;Croatia;Denmark;Bulgaria;Russian Federation | ||||
| 482 | NCT01745770 | January 2013 | 13 June 2016 | TID 1000 mg Mesalazine Versus TID 2x500 mg Mesalazine in Active Ulcerative Colitis (UC) | Double-blind, Double-dummy, Randomised, Multi-centre, Comparative Phase III Clinical Study on the Efficacy and Tolerability of an 8 Week Oral Treatment With Three Times Daily 1000 mg Mesalazine Versus Three Times Daily 2x500 mg Mesalazine in Patients With Active Ulcerative Colitis | Active Ulcerative Colitis | Drug: Mesalazine - TID 1000 mg;Drug: Mesalazine - TID 2x 500 mg | Dr. Falk Pharma GmbH | Not recruiting | 18 Years | 75 Years | Both | 306 | Phase 3 | Germany | |
| 483 | NCT01771224 | January 2013 | 19 February 2015 | Effect of FAn-7 in UC Activity | Effect of Palmitoleic Acid (FAn-7) on Expression of HNF4? and Ulcerative Colitis (UC) Activity | Inflammatory Bowel Disease;Ulcerative Colitis | Dietary Supplement: Palmitoleic acid | National Institute of Medical Sciences and Nutrition, Salvador Zubiran | Recruiting | 18 Years | 59 Years | Both | 20 | Phase 0 | Mexico | |
| 484 | NCT01839214 | January 2013 | 7 April 2015 | A Study to Evaluate the Efficacy and Safety of VB-201 in Patients With Ulcerative Colitis | A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects With Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: VB-201 160mg;Drug: Placebo | Vascular Biogenics Ltd. operating as VBL Therapeutics | Not recruiting | 18 Years | N/A | Both | 112 | Phase 2 | Bulgaria;Hungary;Poland | |
| 485 | NCT02922374 | January 2013 | 31 October 2016 | Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis | Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis: A Prospective Observational Study | Acute Severe Colitis (ASC) | Drug: corticosteroids | Jinling Hospital, China | Not recruiting | 18 Years | N/A | Both | 117 | Phase 1/Phase 2 | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 486 | NCT01647516 | December 12, 2012 | 22 July 2019 | Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo Controlled Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of Induction Therapy With RPC1063 in Patients With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: RPC1063;Drug: placebo | Celgene | Not recruiting | 18 Years | 75 Years | All | 197 | Phase 2 | United States;Belgium;Bulgaria;Greece;Hungary;Israel;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Slovakia;Ukraine;Australia;Canada | |
| 487 | EUCTR2012-003123-38-BE | 11/12/2012 | 28 February 2019 | A CLINICAL EFFICACY AND SAFETY STUDY TO EVALUATE IN A BLINDED WAY THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | A PHASE 2, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PARALLEL-GROUP STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF INDUCTION THERAPY WITH RPC1063 IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE ULCERATIVE COLITIS | Moderately to severely active Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25 mg RPC1063 Pharmaceutical Form: Capsule INN or Proposed INN: RPC1063 Current Sponsor code: RPC1063 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.25- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Product Name: 0.5 mg RPC1063 Pharmaceutical Form: Capsule INN or Proposed INN: RPC1063 Current Sponsor code: RPC1063 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Product Name: 1 mg RPC1063 Pharmaceutical Form: Capsule INN or Proposed INN: RPC1063 Current Sponsor code: RPC1063 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Celgene International II Sàrl (CIS II) | Authorised | Female: yes Male: yes | 86 | Phase 2 | United States;Hungary;Slovakia;Greece;Poland;Belgium;Ukraine;Russian Federation;Israel;Bulgaria;Netherlands;Korea, Republic of | |||
| 488 | EUCTR2012-003974-18-HU | 10/12/2012 | 10 July 2015 | Study to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis | A Randomized, Double-Blind, 12-Week, Placebo-Controlled Study Followed by a 12-Week Extension Phase Without Placebo to Evaluate the Efficacy and Safety of Oral VB-201 in Subjects with Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis MedDRA version: 16.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: VB-201 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Not applicable CAS Number: 630112-41-3 Current Sponsor code: VB-201 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Vascular Biogenics Ltd. | Not Recruiting | Female: yes Male: yes | 110 | Hungary;Bulgaria | ||||
| 489 | NCT01078935 | December 2012 | 19 February 2015 | The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation | The Effect of Probiotics on Bowel Disease | Crohn's Disease;Ulcerative Colitis | Dietary Supplement: probiotics;Dietary Supplement: placebo | The Baruch Padeh Medical Center, Poriya | Ministry of Health, Israel | Not recruiting | 18 Years | 80 Years | Both | 100 | Phase 4 | |
| 490 | NCT01757964 | December 2012 | 16 December 2017 | Bacteriotherapy in Pediatric Inflammatory Bowel Disease | Bacteriotherapy in Pediatric Inflammatory Bowel Disease | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis;CD | Biological: Bacteriotherapy | David Suskind | Seattle Children's Hospital | Not recruiting | 12 Years | 21 Years | All | 13 | Phase 1 | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 491 | NCT04032652 | December 2012 | 29 July 2019 | Use of Rectal Dialysis Technique to Measure Rectal 5-ASA Levels in Healthy Volunteers Receiving Asacol | Measurement of Rectal Levels of 5-aminosalicylic Acid (5-ASA) Using a Novel In-vivo Rectal Dialysis Technique in Healthy Volunteers on Asacol | Ulcerative Colitis | Procedure: Rectal dialysis;Drug: Rectal dialysis | NorthShore University HealthSystem | Not recruiting | 18 Years | 45 Years | All | 2 | Phase 2 | ||
| 492 | EUCTR2010-023798-20-ES | 29/11/2012 | 21 January 2013 | A CLINICAL TRIAL WITH FAT-DERIVED ADULT STEM CELLS TO TREAT ULCERATIVE COLITIS | A PHASE I/IIA CLINICAL TRIAL TO EVALUATE SAFETY AND EFFICACY OF ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS (ASC) ON INDUCTION TO REMISSION IN ULCERATIVE COLITIS - ALOASCU | MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ASC Pharmaceutical Form: Suspension for injection INN or Proposed INN: adipose tissue-derived mesenchymal stem cells Other descriptive name: aloASC Concentration unit: million organisms/ml million organisms/millilitre Concentration type: equal Concentration number: 5- | Fundacion para la Investigacion Biomedica Hospital Universitario La Paz | Authorised | Female: yes Male: yes | Phase 1/2A | Spain | ||||
| 493 | JPRN-UMIN000009364 | 2012/11/24 | 2 April 2019 | Long-term administration of fermented brown rice by Aspergillus oryzae in patients with ulcerative colitis | ulcerative colitis | Patients receive 6 sachets (21 g) of FBRA, brown rice fermented by Aspergillus oryzae, daily (after every meal, 3 times daily) for 2 years. | Graduate School of Medical Science, Kyoto Prefectural University of Medicine | Not Recruiting | 20years-old | Not applicable | Male and Female | 20 | Phase 2 | Japan | ||
| 494 | NCT01620255 | November 2012 | 16 December 2017 | A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis | A Double-blind, Randomized, Placebo-controlled, Parallel, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Moderate To Severe Ulcerative Colitis (Turandot) | Ulcerative Colitis | Drug: Placebo;Drug: PF-00547659 SC Injection | Shire | Not recruiting | 18 Years | 65 Years | All | 357 | Phase 2 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Korea, Republic of;Netherlands;New Zealand;Poland;Russian Federation;Serbia;Slovakia;South Africa;Spain;Croatia;Czech Republic;Norway;Sweden;United Kingdom | |
| 495 | NCT01790061 | November 2012 | 18 January 2018 | Standardized Fecal Microbiota Transplantation for Ulcerative Colitis | Efficacy, Durability and Safety of Standardized Fecal Microbiota Transplantation in Patients With Moderate to Severe Ulcerative Colitis | Bacteria;Microbiota;Fecal Microbiota Transplantation;Inflammatory Bowel Disease;Ulcerative Colitis | Procedure: Standardized FMT;Drug: Traditional treatments | The Second Hospital of Nanjing Medical University | Fourth Military Medical University | Recruiting | 6 Years | 80 Years | All | 500 | Phase 2/Phase 3 | China |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 496 | EUCTR2011-006084-22-GB | 04/10/2012 | 16 October 2012 | Usefulness of the measurement of blood levels of infliximab and adalimumab in inflammatory bowel disease patients in predicting response to treatment | Utilising drug levels and anti-drug antibodies to predict response to treatment in patients with Inflammatory Bowel Disease - Trough levels of anti-TNF agents in inflammatory bowel disease | Inflammatory bowel disease MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Product Name: Infliximab Pharmaceutical Form: Infusion INN or Proposed INN: Infliximab CAS Number: 170277-31-3 Current Sponsor code: Centocor Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 10mg/kg body wt- Trade Name: Humira Product Name: adalimumab Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Adalimumab CAS Number: 331731-18-1 Current Sponsor code: EU/1/03/256/001 Concentration unit: mg milligram(s) Concentration type: not less then Concentration number: 40-mg | Royal Liverpool University Hospital | Authorised | Female: yes Male: yes | 0 | United Kingdom | ||||
| 497 | EUCTR2012-001830-32-HU | 04/10/2012 | 26 November 2018 | A comparative study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with three times daily 1000 mg mesalazine versus three times daily 2x500 mg mesalazine in patients with active ulcerative colitis - TID 1000 mg mesalazine versus TID 2x500 mg mesalazine in active UC | Active ulcerative colitis MedDRA version: 17.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mesalazine 1000 mg gastro-resistant tablets Product Code: Mesalazine 1000 mg gastro-resistant tablets Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: Mesalazine CAS Number: 89-57-6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3000- Pharmaceutical form of the placebo: Gastro-resistant tablet Route of administration of the placebo: Oral use Trade Name: Salofalk® 500 mg gastro-resistant tablet Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg) Product Code: Salofalk® 500 mg tablets Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: Mesalazine CAS Number: 89-57-6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3000- Pharmaceutical form of the placebo: Gastro-resistant tablet Route of administration of the placebo: Oral use | Dr. Falk Pharma GmbH | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia | |||
| 498 | NCT01470612 | October 1, 2012 | 22 October 2019 | Long-Term Study Of CP-690,550 In Subjects With Ulcerative Colitis | A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative Colitis | Drug: CP-690,550 | Pfizer | Not recruiting | 18 Years | N/A | All | 944 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Colombia;Croatia;Czechia;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom;Czech Republic;India | |
| 499 | NCT01418131 | October 2012 | 9 January 2017 | Rectal Tacrolimus in the Treatment of Resistant Ulcerative Proctitis | A Multi-centre Double Blind Randomised Placebo-controlled Study of the Use of Rectal Tacrolimus in the Treatment of Resistant Ulcerative Proctitis | Ulcerative Colitis | Drug: Rectal tacrolimus;Drug: Placebo | The University of Western Australia | Royal Brisbane and Women's Hospital;Royal Adelaide Hospital, Australia;Liverpool Hospital, Australia;Fremantle Hospital and Health Service | Not recruiting | 18 Years | N/A | Both | 21 | Phase 4 | Australia |
| 500 | NCT02306785 | October 2012 | 19 February 2015 | TP0502-Pharmaco-Scintigraphic-Study and Amendment | An Open Label, Single-site Pharmaco-Scintigraphic Study in Healthy Subjects and Patients With Active Ulcerative Colitis With Radio-labelled TP05-tablets to Evaluate the Gastrointestinal Transit and Release Profiles of Two Different Formulations (and Amendment) | Ulcerative Colitis | Drug: TP05 Coating D;Drug: TP05 Coating E;Drug: TP05 Coating H | Tillotts Pharma AG | Not recruiting | 18 Years | 55 Years | Both | 26 | Phase 1 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 501 | EUCTR2012-002023-15-AT | 21/09/2012 | 10 September 2018 | Mesacol: The effect of mesalazine on molecular pathways of cell adhesion in ulcerative colitis | Mesacol: The effect of mesalazine on molecular pathways of cell adhesion in ulcerative colitis - Mesacol | Ulcerative colitis MedDRA version: 14.1 Level: LLT Classification code 10045366 Term: Ulcerative colitis, unspecified System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant 1200 mg magensaftresistente Retardtabletten Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: MESALAZINE CAS Number: 89-57-6 Current Sponsor code: 5-ASA Other descriptive name: 5-aminosalicylic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1200- | Medizinische Universität Wien, Universitätsklinik für Innere Medizin 3, Abteilung für Gastroenterologie und Hepatologie | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Austria | |||
| 502 | JPRN-UMIN000015297 | 2012/09/19 | 23 April 2019 | The feasibility study of accelated infliximab infusion from initial administration | The feasibility study of accelated infliximab infusion from initial administration - The feasibility study of accelated infliximab infusion from initial administration | patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis) | Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure. | Chiba University Hospital | Recruiting | 20years-old | 70years-old | Male and Female | 54 | Phase 2 | Japan | |
| 503 | NCT01697670 | September 2012 | 19 February 2015 | Photodynamic Therapy for Ulcerative Colitis | A Multicenter, Open Phase II Study to Assess the Effect and Safety of Low Dose Photodynamic Therapy in Patients With Moderate to Severe Active Distal Ulcerative Colitis | Ulcerative Colitis | Drug: Photodynamic therapy with Gliolan | University of Zurich | Swiss National Science Foundation | Recruiting | 18 Years | N/A | Both | 7 | Phase 1 | Switzerland |
| 504 | JPRN-UMIN000008352 | 2012/08/01 | 2 April 2019 | Switch Trial from Several Times to Once Daily Oral Mesalazine Administration in Patients with Quiescent Ulcerative Colitis | Ulcerative Colitis | Switch from several times to once daily oral mesalazine administration | Saitama Medical Center, Saitama Medical University | Not Recruiting | 15years-old | 70years-old | Male and Female | 50 | Not selected | Japan | ||
| 505 | NCT03079700 | August 1, 2012 | 16 December 2017 | Immune Modulation From Trichuris Suis | Mucosal and Systemic Immune Modulation From Trichuris Suis in a Self-infected Individual | Crohn Disease;Ulcerative Colitis;Intestinal Helminthiasis | Biological: Trichuris suis eggs | University of Aarhus | Not recruiting | 18 Years | 70 Years | Male | 1 | N/A | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 506 | NCT01433471 | August 2012 | 19 October 2017 | Mucosal Immunity of Ulcerative Colitis Patients Undergoing Therapy With Trichuris Suis Ova | Mucosal Immunity of Ulcerative Colitis Patients Undergoing Therapy With Trichuris Suis Ova | Ulcerative Colitis | Drug: Trichuris suis ova | New York University School of Medicine | Not recruiting | 18 Years | 72 Years | All | 4 | N/A | United States | |
| 507 | NCT01659138 | August 2012 | 8 August 2016 | Efficacy and Safety of SAR339658 in Patients With Moderate to Severe Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating Efficacy and Safety of SAR339658 in Patients With Active Moderate to Severe Ulcerative Colitis (UC) | Ulcerative Colitis | Drug: SAR339658;Other: Placebo | Sanofi | Not recruiting | 18 Years | 70 Years | Both | 28 | Phase 2 | United States;Austria;Canada;France;Germany;Italy;Poland;Belgium | |
| 508 | NCT01678911 | August 2012 | 19 October 2017 | Efficacy of Gralise® for Chronic Pelvic Pain | Efficacy of Gralise® for Chronic Pelvic Pain | Irritable Bowel Syndrome;Ulcerative Colitis;Interstitial Cystitis;Prostatitis;Pelvic Pain | Drug: Gralise | Shirley Ryan AbilityLab | Not recruiting | 18 Years | N/A | All | 11 | Phase 4 | United States | |
| 509 | NCT01783119 | August 2012 | 19 February 2015 | Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative Colitis | Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative Colitis | Ulcerative Colitis | Dietary Supplement: Aloe Barbadensis Miller;Dietary Supplement: placebo water | National Institute of Medical Sciences and Nutrition, Salvador Zubiran | Recruiting | 18 Years | 59 Years | Both | 60 | Phase 0 | Mexico | |
| 510 | NCT01458574 | July 20, 2012 | 16 December 2017 | A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis | A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis | Ulcerative Colitis | Drug: Placebo;Drug: CP690,550;Drug: CP-690,550 | Pfizer | Not recruiting | 18 Years | N/A | All | 593 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Colombia;Croatia;Czech Republic;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;Japan;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 511 | NCT01612039 | July 2012 | 10 October 2016 | Safety, Efficacy, and Tolerability Study of ASP3291 in Patients With Active Ulcerative Colitis | A Phase 2, Randomized, Double-Blind, Parallel, Placebo-Controlled, Proof-of-Concept Study to Assess the Efficacy, Safety, and Tolerability of ASP3291 in Patients With Active Ulcerative Colitis | Ulcerative Colitis | Drug: ASP3291;Drug: Placebo | Telsar Pharma Inc. | Not recruiting | 18 Years | 65 Years | Both | 112 | Phase 2 | United States | |
| 512 | NCT01640496 | July 2012 | 19 February 2015 | Vitamin D Treatment in Ulcerative Colitis | Vitamin D Treatment in Ulcerative Colitis | Ulcerative Colitis;Inflammatory Bowel Disease | Drug: Vitamin D3;Other: Placebo | University of Chicago | North Shore University Hospital | Not recruiting | 18 Years | N/A | Both | 0 | N/A | United States |
| 513 | EUCTR2011-005251-13-GR | 05/06/2012 | 28 May 2018 | A study to find out more about the effect of AMG 181 in people with moderate to severe ulcerative colitis | A Randomized, Double blind, Multiple Dose Placebo Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 181 in Subjects with Moderate to Severe Ulcerative Colitis | Moderate to severe Ulcerative Colitis MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: AMG 181 Product Code: AMG 181 Pharmaceutical Form: Solution for injection INN or Proposed INN: AMG 181 Current Sponsor code: AMG 181 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 70- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Amgen Inc | Not Recruiting | Female: yes Male: yes | 315 | Phase 2 | United States;Estonia;Greece;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Latvia;Germany;Norway | |||
| 514 | JPRN-UMIN000007806 | 2012/06/01 | 2 April 2019 | The feasibility study of accelated infliximab infusion during maintenance phase | patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis) | Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure. | Chiba University Hospital | Not Recruiting | Not applicable | Not applicable | Male and Female | 54 | Phase 2 | Japan | ||
| 515 | NCT01458951 | June 2012 | 19 October 2017 | A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis | A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis. | Ulcerative Colitis | Drug: tofacitinib;Drug: Placebo | Pfizer | Not recruiting | 18 Years | N/A | All | 547 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Canada;Colombia;Croatia;Czech Republic;Denmark;Estonia;France;Germany;Hungary;Israel;Korea, Republic of;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Taiwan;Ukraine;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 516 | NCT01586533 | June 2012 | 19 February 2015 | Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis | A Phase II Double-blind, Randomized, Comparator-controlled Study of the Safety and Efficacy of Zoenasa™ Rectal Gel (Mesalamine Plus N-acetylcysteine) in Subjects With Left-sided Ulcerative Colitis | Ulcerative Colitis;Left-sided Ulcerative Colitis;Distal Ulcerative Colitis | Drug: Zoenasa-1:4;Drug: Mesalamine Enema | Altheus Therapeutics, Inc. | Not recruiting | 18 Years | 64 Years | Both | 120 | Phase 2 | United States | |
| 517 | NCT01536535 | May 1, 2012 | 9 October 2018 | Predicting Response to Standardized Pediatric Colitis Therapy | Multicenter Open-label Study Evaluating the Safety and Efficacy of Standardized Initial Therapy Using Either Mesalamine or Corticosteroids Then Mesalamine to Treat Children and Adolescents With Newly Diagnosed Ulcerative Colitis. | Ulcerative Colitis | Drug: Mesalamine;Drug: Corticosteroid;Drug: Corticosteroids then mesalamine | Connecticut Children's Medical Center | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Not recruiting | 4 Years | 17 Years | All | 467 | Phase 4 | United States;Canada |
| 518 | NCT01387594 | May 2012 | 16 December 2017 | Evaluate PF-00547659 On Cerebrospinal Fluid Lymphocytes In Volunteers With Crohn's Disease Or Ulcerative Colitis Who Failed Or Did Not Tolerate Anti-TNFs | A Multi-Center, Phase 1, Open-Label Evaluation Of The Effect Of PF-00547659 (Anti Madcam Monoclonal Antibody) On Cerebrospinal Fluid (CSF) Lymphocytes In Volunteers With Crohns Disease Or Ulcerative Colitis Who Are Anti-TNFInadequate Responders (TOSCA) | Crohn's Disease;Ileitis;Ileo-colonic and Colonic Crohn's Disease;Granulomatous Colitis;Regional Enteritis;Ulcerative Colitis | Procedure: lumbar puncture;Drug: lumbar puncture | Shire | Not recruiting | 18 Years | 75 Years | All | 49 | Phase 1 | Austria;Belgium;France;Germany;Netherlands | |
| 519 | EUCTR2011-002411-29-SE | 26/04/2012 | 14 March 2016 | A Multicenter Study to Evaluate the Effects of Adalimumab on Quality of Life, Health Care Treatments and Health Care Costs in Subjects with Ulcerative Colitis. | An Open-Label Multicenter Study to Evaluate the Impact of Adalimumab on Quality of Life, Health Care Utilization and Costs of Ulcerative Colitis Subjects in the Usual Clinical Practice Setting. - N/A | Ulcerative Colitis MedDRA version: 14.1 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringe Product Name: adalimumab Pharmaceutical Form: Solution for injection INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- | AbbVie Deutschland GmbH & Co. KG | Not Recruiting | Female: yes Male: yes | 455 | Sweden;Norway;Germany;Denmark;Belgium;Poland;Canada;Czech Republic;France;United Kingdom;Switzerland;Italy;Israel;Austria;Turkey;Ireland;Spain;Finland;Greece;Slovakia;Portugal | ||||
| 520 | EUCTR2011-004581-14-EE | 26/04/2012 | 28 February 2019 | A multi-center, open-label study of CP-690,550 in subjects with moderate to severe ulcerative colitis | A MULTI-CENTER, OPEN-LABEL STUDY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Tofacitinib citrate (clinical trial image) Product Code: CP-690,550-10 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: tofacitinib CAS Number: 540737-29-9 Current Sponsor code: CP-690,550-10 Other descriptive name: tofacitinib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Product Name: Tofacitinib citrate (Proposed commercial formulation – debossed) Product Code: CP-690,550-10 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: tofacitinib CAS Number: 540737-29-9 Current Sponsor code: CP-690,550-10 Other descriptive name: tofacitinib Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- | Pfizer Inc, 235 East 42nd Street, New York, New York 10017 | Authorised | Female: yes Male: yes | 900 | Phase 3 | Serbia;United States;Taiwan;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Israel;Colombia;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 521 | NCT01465763 | April 2012 | 19 October 2017 | A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis | A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis | Ulcerative Colitis | Drug: tofacitinib;Drug: Placebo | Pfizer | Not recruiting | 18 Years | N/A | All | 614 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Colombia;Croatia;Czech Republic;Denmark;Estonia;France;Germany;Hungary;Israel;Italy;Japan;Latvia;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Ukraine;United Kingdom;Brazil | |
| 522 | NCT01551290 | April 2012 | 17 November 2015 | A Study to Evaluate the Effectiveness and Safety of Infliximab in Chinese Patients With Active Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Infliximab in Chinese Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Drug: Infliximab;Drug: Placebo | Xian-Janssen Pharmaceutical Ltd. | Not recruiting | 18 Years | 65 Years | Both | 99 | Phase 3 | China | |
| 523 | NCT01877577 | April 2012 | 19 February 2015 | Supplementation of Vitamin D3 in Patients With Inflammatory Bowel Diseases and Hypovitaminosis D | Supplementation of Vitamin D3 (Cholecalciferol) in Patients With Inflammatory Bowel Diseases (IBD) and Hypovitaminosis D: A Prospective Randomized Controlled Trial. | Crohn's Disease (CD);Ulcerative Colitis (UC) | Dietary Supplement: Vitamin D3 | University of California, San Francisco | Not recruiting | 18 Years | N/A | Both | 30 | N/A | United States | |
| 524 | EUCTR2011-005115-82-HU | 26/03/2012 | 9 December 2013 | An 8 week study to compare budesonide MMX 9 mg versus placebo in patients with mild to moderate ulcerative colitis who experience a flare of their disease while taking an existing 5 aminosalicylic acid. | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients with Active, Mild or Moderate Ulcerative Colitis not Adequately Controlled on a Background Oral 5-ASA Regimen | Ulcerative Colitis MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® Pharmaceutical Form: Film coated gastro-resistant tablet INN or Proposed INN: BUDESONIDE CAS Number: 51333-22-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 9- Pharmaceutical form of the placebo: Film coated gastro-resistant tablet Route of administration of the placebo: Oral use | Santarus, Inc. | Not Recruiting | Female: yes Male: yes | 500 | United States;Estonia;Czech Republic;Hungary;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | ||||
| 525 | NCT01506362 | March 2012 | 19 October 2017 | Efficacy, Pharmacodynamics, Safety and Tolerability of Oral BL-7040 in Patients With Moderately Active Ulcerative Colitis | An Open-Label Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of Oral BL-7040 in Patients With Moderately Active Ulcerative Colitis | Ulcerative Colitis | Drug: BL-7040 | BioLineRx, Ltd. | Not recruiting | 18 Years | 70 Years | All | 22 | Phase 2 | Israel | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 526 | EUCTR2011-004770-28-ES | 28/02/2012 | 25 September 2012 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-Carnitine (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment. - Propionyl-L-Carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 14.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 Pharmaceutical Form: Tablet INN or Proposed INN: Levocarnitine propyl hydrochloride CAS Number: 119793-66-7 Current Sponsor code: (ST261) Propionyl-L-carnitine hydrochloride Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid Concentration unit: mg milligram(s) Concentration type: not less then Concentration number: 500- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | Authorised | Female: yes Male: yes | 444 | Phase 3 | Hungary;Germany;France;Spain;Latvia;Poland;Austria;Lithuania | |||
| 527 | EUCTR2011-002818-37-BE | 15/02/2012 | 21 August 2017 | A Phase II study to investigate GSK1605786 fo the treatment of patients with Ulcerative Colitis. | A phase II, 20-week, multi-centre, randomised, double-blind, placebo-controlled, parallel group proof of concept study to investigate the efficacy and safety of GSK1605786 for treatment of patients with active Ulcerative Colitis. | Subjects with Active Ulcerative Colitis. MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: GSK1605786A Product Code: GSK1605786A Pharmaceutical Form: Capsule, hard Current Sponsor code: GSK1605786A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | GlaxoSmithKline Research & Development Ltd | Not Recruiting | Female: yes Male: yes | 45 | Phase 2 | United Kingdom;Netherlands;Belgium | |||
| 528 | EUCTR2011-003532-32-LT | 14/02/2012 | 26 November 2013 | A Pilot Study to Evaluate Safety and Efficacy of LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis | Phase 2 Assessment of the Relationship between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects with Acute, Mild to Moderate Ulcerative Colitis | Acute mild to moderate ulcerative colitis MedDRA version: 14.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LX1606 Product Code: LX1606 Pharmaceutical Form: Capsule INN or Proposed INN: Telotristat etiprate CAS Number: 1137608-69-5 Current Sponsor code: LX1606, LX1032 Other descriptive name: telotristat etiprate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Lexicon Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Lithuania;Belgium;Poland;Slovakia;United States | |||
| 529 | NCT01453491 | February 13, 2012 | 16 December 2017 | A Phase 1b Study to Assess the Safety and Anti-inflammatory Effects of Two Different Doses of SRT2104 in Patients With Ulcerative Colitis | A Phase 1b, Exploratory Study to Assess the Safety, Tolerability, Colonic Tissue Exposure, and Anti-Inflammatory Effects of Two Different Doses of SRT2104 in Subjects With Mild to Moderate Ulcerative Colitis | Colitis, Ulcerative | Drug: SRT2104 | Sirtris, a GSK Company | GlaxoSmithKline | Not recruiting | 18 Years | 75 Years | All | 17 | Phase 1 | United States |
| 530 | JPRN-UMIN000007341 | 2012/02/01 | 10 September 2019 | The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab | The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab - The study of the effectiveness of maintenance treatment with infliximab for ulcerative colitis patients who respond to induction treatment with infliximab | ulcerative colitis | Patients in maintenance group receive intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 and then every 8 weeks (up to week 54). Patients in discontinuation group receive intravenous infusion of infliximab (5mg/kg) at week 0, 2, and 6 (not receiving infliximab at week 14, 22, 30, 38, 46 and 54). | Tohoku University Graduate School of Medicine (Tohoku University Hospital) | Not Recruiting | 20years-old | Not applicable | Male and Female | 90 | Not applicable | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 531 | NCT01393405 | February 2012 | 11 June 2018 | Methotrexate in Induction and Maintenance of Steroid Free Remission in Ulcerative Colitis | Randomized, Double Blind, Prospective Trial Investigating the Efficacy of Methotrexate in Induction and Maintenance of Steroid Free Remission in Ulcerative Colitis (MEthotrexate Response In Treatment of UC - MERIT-UC) | Ulcerative Colitis | Drug: Methotrexate | University of North Carolina, Chapel Hill | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Not recruiting | 18 Years | 70 Years | All | 179 | Phase 2 | United States |
| 532 | NCT01517607 | February 2012 | 12 October 2015 | Mesalazine (PENTASA®) in Ulcerative Colitis | Mesalazine (PENTASA®) in Ulcerative Colitis: Correlation of the Information Level With Patient's Compliance in Everyday Practice | Ulcerative Colitis | Other: Mesalazine | Ferring Pharmaceuticals | Ferring Arzneimittel GmbH | Not recruiting | 18 Years | N/A | Both | 506 | N/A | Germany |
| 533 | NCT01532648 | February 2012 | 19 February 2015 | Randomized Placebo Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 mg in Patients With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA). | Ulcerative Colitis | Drug: Budesonide;Drug: Placebo;Procedure: Procedure/Surgery: Blood sampling, endoscopy | Salix Pharmaceuticals | Not recruiting | 18 Years | 75 Years | Both | 509 | Phase 3 | United States;Bulgaria;Canada;Czech Republic;Estonia;Hungary;Latvia;Lithuania;Poland;Russian Federation;Ukraine | ||
| 534 | NCT01562314 | February 2012 | 19 October 2017 | A Pilot Study of GWP42003 in the Symptomatic Treatment of Ulcerative Colitis (GWID10160) | A Randomised, Double-blind, Placebo-controlled Parallel Group, Pilot Study of GWP42003 in the Symptomatic Treatment of Ulcerative Colitis. | Ulcerative Colitis | Drug: GWP42003;Drug: Placebo | GW Research Ltd | Not recruiting | 18 Years | N/A | All | 60 | Phase 2 | Czech Republic;United Kingdom | |
| 535 | NCT01585155 | February 2012 | 25 May 2015 | Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis | Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of TA-650 in Pediatric Patients With Moderate to Severe Ulcerative Colitis. | Pediatric Ulcerative Colitis | Drug: TA-650 | Mitsubishi Tanabe Pharma Corporation | Not recruiting | 6 Years | 17 Years | Both | 21 | Phase 3 | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 536 | NCT01456052 | January 30, 2012 | 16 December 2017 | A Study to Evaluate Safety and Efficacy of LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis | Phase 2 Assessment of the Relationship Between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: 500 mg LX1606 QD;Drug: 500 mg LX1606 TID;Drug: Placebo | Lexicon Pharmaceuticals | Not recruiting | 18 Years | 70 Years | All | 59 | Phase 2 | United States;Lithuania;Poland;Slovakia | |
| 537 | EUCTR2011-004812-40-DE | 26/01/2012 | 14 October 2013 | Evaluation of efficacy and safety of tralokinumab in patients with active, moderate-to-severe ulcerative colitis. | A phase IIa, randomised, double-blind, placebo-controlled, parallel-arm, multicenter study to evaluate the efficacy and safety of tralokinumab (CAT-354), a recombinant human monoclonal antibody directed against interleukin-13 (IL-13), as add-on therapy, on clinical response in patients with active, moderate-to-severe, ulcerative colitis | Ulcerative Colitis MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: tralokinumab Product Code: CAT-354 Pharmaceutical Form: Solution for injection INN or Proposed INN: tralokinumab CAS Number: 1044515-88-9 Current Sponsor code: CAT-354 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | AstraZeneca AB | Not Recruiting | Female: yes Male: yes | 110 | Phase 2a | Italy;United Kingdom;Germany;Netherlands;Czech Republic | |||
| 538 | EUCTR2011-004765-32-BE | 10/01/2012 | 21 August 2017 | Investigation of the potential side effects and effects on the large bowel of Propionyl-L-carnitine Hydrochloride (ST 261) (given as tablets that release the active ingredient only in the large bowel) in Patients with Mild Ulcerative Colitis that are concomitantly treated with a Stable dose of aminosalicylates | Phase III, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter International Study to Investigate the Safety and Efficacy of Propionyl-L-carnitine Hydrochloride (ST261) Modified Release Tablets in Patients Affected by Mild Ulcerative Colitis under Oral Stable Treatment - Propionyl-L-carnitine in Ulcerative Colitis | Mild ulcerative colitis MedDRA version: 14.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PROPIONYL L-CARNITINE Product Code: ST 261 Pharmaceutical Form: Tablet INN or Proposed INN: Levocarnitine propyl hydrochloride CAS Number: 119793-66-7 Current Sponsor code: (ST261) Propionyl-L-carnitine Other descriptive name: (R)-3-(1-oxo-propoxy)-4-(N,N,N-trimethyl amonium chloride)-butanoic acid Concentration unit: mg milligram(s) Concentration type: not less then Concentration number: 500- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. | Not Recruiting | Female: yes Male: yes | 444 | Phase 3 | Czech Republic;Slovakia;Belgium;Netherlands;Italy | |||
| 539 | EUCTR2011-003283-78-IT | 09/01/2012 | 27 January 2014 | A PROOF-OF-CONCEPT CLINICAL STUDY, TO ASSESS THE EFFECT OF GED-0507-34-Levo 80 mg Tablets IN INDUCTION OF REMISSION OF ACTIVE ULCERATIVE COLITIS | A PROOF-OF-CONCEPT CLINICAL STUDY, TO ASSESS THE EFFECT OF GED-0507-34-Levo 80 mg Tablets IN INDUCTION OF REMISSION OF ACTIVE ULCERATIVE COLITIS | Active Ulcerative Colitis Patients MedDRA version: 14.1 Level: LLT Classification code 10021184 Term: IBD System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: NA Product Code: GED-0507-34-Levo Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: (-)-3-(4-Aminophenyl)-2-methoxypropionic acid CAS Number: NA Current Sponsor code: GED-0507-34-Levo Other descriptive name: NA Concentration unit: mg/g milligram(s)/gram Concentration type: up to Concentration number: 160- | GIULIANI | Not Recruiting | Female: yes Male: yes | Italy | |||||
| 540 | EUCTR2011-005693-36-IT | 09/01/2012 | 9 October 2012 | Evaluation of the number of colon intraephitelial tumours in patients with ulcerative colitis after oral administration of the vital dye methylene blue | Intraepithelial neoplasia detection rate after single oral dose of methylene blue MMX modified release tablets administered to patients with long standing ulcerative colitis undergoing colonoscopy - NA | Patients affecetd by Long standing ulcerative colitis MedDRA version: 14.1 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Methylene blue 25mg tablets Product Code: NA Pharmaceutical Form: Modified-release tablet INN or Proposed INN: METHYLENE BLUE Current Sponsor code: NA Other descriptive name: NA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- | COSMO TECHNOLOGIES LTD | Not Recruiting | Female: yes Male: yes | Italy | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 541 | NCT01494857 | January 2012 | 19 February 2015 | Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Ulcerative Colitis | Open-Label, Non-Randomized, Single Patient Group, Multi-Center Study to Evaluate the Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Adalimumab | Clalit Health Services | Recruiting | 18 Years | N/A | Both | 200 | Phase 3 | Israel | |
| 542 | NCT01534312 | January 2012 | 28 November 2016 | Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study) | Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study) | Colitis, Ulcerative;Inflammatory Bowel Diseases | Drug: CGMP protein;Drug: Maximal oral 5ASA | University of Aarhus | Arla Foods | Not recruiting | 18 Years | N/A | Both | 24 | N/A | Denmark |
| 543 | EUCTR2010-020448-37-NL | 21/12/2011 | 4 August 2015 | Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis. | Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis. | Active Ulcerative Colitis MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PEG-liposomal prednisolone sodium phosphate Product Code: Nanocort Pharmaceutical Form: Concentrate and diluent for solution for infusion INN or Proposed INN: Prednisolone Sodium Phosphate CAS Number: 125-02-0 Current Sponsor code: Nanocort Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 1.0 -3.2 Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intravenous use | Enceladus Pharmaceuticals | Not Recruiting | Female: yes Male: yes | 20 | Phase 2A | Belgium;Netherlands | |||
| 544 | EUCTR2011-003532-32-SK | 19/12/2011 | 27 January 2014 | A Pilot Study to Evaluate Safety and Efficacy of LX1606 in Subjects With Acute, Mild to Moderate Ulcerative Colitis | Phase 2 Assessment of the Relationship between Serotonin and Efficacy in Ulcerative Colitis: A Multi-Center Randomized, Double Blind, Placebo-Controlled, Pilot Study to Evaluate Safety and Preliminary Efficacy of Orally Administered LX1606 in Subjects with Acute, Mild to Moderate Ulcerative Colitis | Acute mild to moderate ulcerative colitis MedDRA version: 14.0 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: LX1606 Product Code: LX1606 Pharmaceutical Form: Capsule INN or Proposed INN: Non as of yet CAS Number: 1137608-69-5 Current Sponsor code: LX1606, LX1032 Other descriptive name: telotristat etiprate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Lexicon Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Lithuania;Poland;Belgium;Slovakia;United States | |||
| 545 | EUCTR2011-004268-31-DK | 13/12/2011 | 17 August 2015 | Adalimumab (Humira) in the treatment of chronic pouchitis | Adalimumab (Humira) in the treatment of chronic pouchitis | Chronic pouchitis after proctocolectomy and reconstruction with a J-pouch and with ulcerative colitis as primary diagnosis MedDRA version: 14.0 Level: PT Classification code 10036463 Term: Pouchitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Humira 40 mg solution for injection in pre-filled syringes Product Name: Humira Product Code: EMEA/H/C/000481 Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Odense University Hospital | Not Recruiting | Female: yes Male: yes | 24 | Denmark | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 546 | NCT01434576 | December 2011 | 19 February 2015 | Study to Evaluate the Pharmacodynamics and Safety of HGS1025 in Patients With Ulcerative Colitis | A Phase 1b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacodynamics and Safety of HGS1025, a Human Monoclonal Anti-CCR5 Antibody, in Subjects With Ulcerative Colitis | Ulcerative Colitis | Biological: HGS1025;Drug: Placebo | Human Genome Sciences Inc. | Not recruiting | 18 Years | N/A | Both | 0 | Phase 1 | ||
| 547 | NCT01496053 | December 2011 | 28 April 2015 | Anti-inflammatory Effect of Agaricus Blazei Murill in Inflammatory Bowel Disease (IBD) | Anti-inflammatory Effect of a Mushroom Extract (AndoSan)in Patients With Inflammatory Bowel Disease. A Prospective Study | Ulcerative Colitis;Crohn's Disease;Inflammatory Bowel Disease | Dietary Supplement: AndoSan;Dietary Supplement: Sugar Extract | Oslo University Hospital | ImmunoPharma | Recruiting | 18 Years | 60 Years | Both | 100 | Phase 2/Phase 3 | Norway |
| 548 | NCT02306772 | December 2011 | 19 February 2015 | TP0501 - Pharmaco-Scintigraphic-Study | An Open Label, Single-site Pharmaco-Scintigraphic Study in Healthy Subjects With Radio-labelled TP05-tablets (Mesalazine) to Evaluate the Gastrointestinal Transit and Release Profiles of Two Different Formulations. | Ulcerative Colitis | Drug: TP05 Coating A;Drug: TP05 Coating B | Tillotts Pharma AG | Not recruiting | 18 Years | 55 Years | Both | 18 | Phase 1 | ||
| 549 | NCT01461317 | November 30, 2011 | 16 December 2017 | Study to Evaluate the Long-term Safety of Etrolizumab in Participants With Moderate to Severe Ulcerative Colitis | A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: Etrolizumab | Genentech, Inc. | Not recruiting | 18 Years | 75 Years | All | 121 | Phase 2 | United States;Australia;Belgium;Canada;Czech Republic;Germany;Hungary;Israel;New Zealand;Spain;United Kingdom | |
| 550 | EUCTR2011-003208-19-GB | 16/11/2011 | 28 February 2019 | GWP42003 symptomatic treatment of ulcerative colitis. | A randomised, double-blind, placebo-controlled parallel group, pilot study of GWP42003 in the symptomatic treatment of ulcerative colitis. | Symptoms of diarrhoea, rectal bleeding, stool frequency and inflammation in subjects with ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: GWP42003 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Not applicable CAS Number: 13956-29-1 Current Sponsor code: GWP42003 Other descriptive name: CANNABIDIOL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | GW Pharma Ltd. | Not Recruiting | Female: yes Male: yes | 62 | Phase 2 | Czech Republic;United Kingdom | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 551 | EUCTR2011-002462-20-DE | 25/10/2011 | 29 April 2013 | Clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis | Randomised, double-blind, placebo-controlled prospective clinical trial to evaluate the efficacy and safety of K(D)PT in patients with mild to moderate ulcerative colitis - K(D)PT in ulcerative colitis: proof of concept study | Acute mild to moderate ulcerative colitis. MedDRA version: 14.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: KdPT Product Code: 20 mg Pharmaceutical Form: Powder and solvent for oral solution Current Sponsor code: K(D)PT Acetate Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Powder and solvent for oral solution Route of administration of the placebo: Oral use Product Name: KdPT Product Code: 50 mg Pharmaceutical Form: Powder and solvent for oral solution Current Sponsor code: K(D)PT Acetate Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Powder and solvent for oral solution Route of administration of the placebo: Oral use Product Name: KdPT Product Code: 100 mg Pharmaceutical Form: Powder and solvent for oral solution Current Sponsor code: K(D)PT Acetate Other descriptive name: L-Lysyl-D-Prolyl-L-Threonine Acetate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Powder and solvent for oral solution Route of administration of the placebo: Oral use | Dr August Wolff GmbH & Co KG Arzneimittel | Not Recruiting | Female: yes Male: yes | 160 | Italy;Germany;Poland;Czech Republic;Hungary | ||||
| 552 | EUCTR2011-003130-14-GB | 06/10/2011 | 25 September 2012 | A study to see how effective and safe the drug Kappaproct is in patients with refractory ulcerative colitis when added to their standard care of treatment | A placebo-controlled, double-blind, randomised study to assess the efficacy and safety of Kappaproct as an add-on to current practice in chronic active treatment refractory ulcerative colitis patients - | Chronic active treatment refractory ulcerative colitis MedDRA version: 14.1 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Kappaproct Pharmaceutical Form: Rectal solution Current Sponsor code: DIMS0150 Other descriptive name: DIMS0150 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 15.6- Pharmaceutical form of the placebo: Rectal capsule Route of administration of the placebo: Rectal use | InDex Pharmaceuticals AB | Authorised | Female: yes Male: yes | 120 | Hungary;Czech Republic;Germany;United Kingdom;Italy;Poland | ||||
| 553 | JPRN-UMIN000006141 | 2011/10/01 | 2 April 2019 | Comparative study of Infliximab monotherapy vs combined therapy with azathiopurine for inducing and maintaining clinical remission in steroid-dependent or -resistant ulcerative colitis | ulcerative colitis | Patients in Infliximab monotherapy receive intravenous infusion of IFX at week 0, 2, and 6, and then every 8 weeks (up to week 54). Patients in the combination therapy of Infliximab and azathiopurine receive intravenous infusion of IFX (at week 0, 2, 6, and then every 8 weeks) and oral azathiopurine (up to week 54). | Department of Gastroenterology and Hepatology, Kyoto University Hospital | Not Recruiting | 16years-old | 75years-old | Male and Female | 50 | Not applicable | Japan | ||
| 554 | NCT01336465 | September 2011 | 22 August 2016 | Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis | Phase II Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of rhuMAb Beta7 in Patients With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: rhuMAb Beta7;Drug: placebo | Genentech, Inc. | Not recruiting | 18 Years | 75 Years | Both | 124 | Phase 2 | United States;Australia;Belgium;Canada;Czech Republic;Germany;Hungary;Israel;New Zealand;Spain;United Kingdom | |
| 555 | EUCTR2011-000897-80-BE | 16/08/2011 | 16 August 2016 | A clinical study to investigate the safety and efficacy of the product rhuMAb BETA7 in treating patients with ulcerative colitis, a form of inflammatory bowel disease | PHASE II RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF rhuMAb BETA7 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS | Ulcerative colitis MedDRA version: 14.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: rhuMAb Beta7 Product Code: PRO145223 (RO5490261) Pharmaceutical Form: Solution for injection INN or Proposed INN: n.a. Current Sponsor code: PRO145223 (RO5490261) Other descriptive name: rhuMAb Beta7 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Genentech, Inc. | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Hungary;Czech Republic;Canada;Spain;Belgium;Australia;Israel;Germany;United Kingdom;New Zealand | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 556 | EUCTR2010-023797-39-GB | 12/08/2011 | 28 January 2013 | TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE | TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH INFLAMMATORY BOWEL DISEASE USING FERROUS SULPHATE OR COSMOFER: TOLERANCE AND EFFECTS ON HAEMOGLOBIN, DISEASE ACTIVITY, MOOD, QUALITY OF LIFE AND AUTONOMIC NERVOUS SYSTEM ACTIVITY. AN OPEN LABEL PHASE IV NON-INFERIORITY STUDY. - TREATMENT OF IRON DEFICIENCY ANAEMIA IN ADOLESCENTS WITH IBD. | Inflammatory bowel disease MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Iron sulphate 200mg coated tablets Product Name: Ferrous sulphate Product Code: Ferrous sulphate Pharmaceutical Form: Tablet INN or Proposed INN: Iron sulphate CAS Number: 7720-78-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Trade Name: CosmoFer Product Name: CosmoFer 50mg/ml solution for infusion or injection Pharmaceutical Form: Solution for infusion INN or Proposed INN: iron(III)- hydroxide dextran complex CAS Number: 9004-66-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- | Barts Health NHS Trust | Authorised | Female: yes Male: yes | Phase 4 | United Kingdom | ||||
| 557 | NCT01340872 | August 2011 | 12 September 2016 | Safety and Efficacy Study of Oral Ferric Iron To Treat Iron Deficiency Anaemia in Quiescent Ulcerative Colitis (AEGIS-1) | A Prospective, Multicentre, Randomised, Double-blind, Placebo Controlled Study With Oral ST10-021 for the Treatment of Iron Deficiency Anaemia in Subjects With Quiescent Ulcerative Colitis Where Oral Ferrous Preparations Have Failed or Cannot be Used (AEGIS 1) | Iron Deficiency Anaemia;Inflammatory Bowel Disease;Ulcerative Colitis | Drug: ST10-021;Drug: Placebo Comparator | Iron Therapeutics | Not recruiting | 18 Years | N/A | Both | 58 | Phase 3 | Austria;United Kingdom | |
| 558 | JPRN-UMIN000005824 | 2011/07/01 | 2 April 2019 | Examination of efficacy and safety of tacrolimus, immunomodulator for an outpatient with moderate to severe ulcerative colitis | ulcerative colitis | Tacrolimus (12weeks) | Juntendo University | Recruiting | 16years-old | 65years-old | Male and Female | 20 | Not applicable | Japan | ||
| 559 | NCT01320436 | July 2011 | 23 February 2016 | Curcumin + Aminosalicylic Acid (5ASA) Versus 5ASA Alone in the Treatment of Mild to Moderate Ulcerative Colitis | Randomized, Double-blind, Placebo-controlled Study to Evaluated the Efficacy of Combining Curcumin+5ASA Medication Versus 5ASA Medication Alone on Active Mild to Moderate Ulcerative Colitis Patients | Ulcerative Colitis | Dietary Supplement: Curcumin;Drug: 5-aminosalicylic acid | Sheba Medical Center | Not recruiting | 18 Years | 70 Years | Both | 50 | Phase 3 | Israel | |
| 560 | EUCTR2011-002061-38-BE | 29/06/2011 | 21 August 2017 | Treating patients with infliximab based on their trough levels | A randomised prospective trough level monitoring study with real-time therapeutic adaptations: Trough level Adapted infliXImab Treatment scheme (TAXIT). - TAXIT | 2) Crohn's disease and ulcerative colitis MedDRA version: 13.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 13.1 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Remicade Product Name: Remicade Product Code: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- | Katholieke Universiteit Leuven | Not Recruiting | Female: yes Male: yes | Phase 4 | Belgium | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 561 | JPRN-UMIN000011236 | 2011/05/02 | 2 April 2019 | Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation -Efficacy of on-demand therapy for induction and maintenance of remission - | Ulcerative colitis | Upon appearance of rectal bleeding, once daily administration of a 500 mg mesalazine suppository until disappearance of rectal bleeding. | Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine | Not Recruiting | 15years-old | 65years-old | Male and Female | 200 | Not selected | Japan | ||
| 562 | NCT01346826 | May 2011 | 8 August 2016 | Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease (IBD) | Safety of Accelerated Infliximab Infusions in Patients With Inflammatory Bowel Disease: A Prospective, Randomized, Double-Blind, Controlled Trial | Crohn's Disease;Ulcerative Colitis | Drug: Standard 2 hours-infusion;Drug: Accelerated 1 hour-infusion;Drug: Accelerated 30 minutes-infusion | Asan Medical Center | Not recruiting | 16 Years | 80 Years | Both | 145 | Phase 4 | Korea, Republic of | |
| 563 | NCT01772615 | May 2011 | 19 February 2015 | Treatment of Ulcerative Colitis With Ciprofloxacin and E. Coli Nissle | Active Ulcerative Colitis; Placebo Controlled Treatment Trial With Ciprofloxacin and E. Coli Nissle | Ulcerative Colitis | Drug: Ciprofloxacin;Dietary Supplement: E. coli Nissle | Hvidovre University Hospital | Not recruiting | 18 Years | N/A | Both | 100 | Phase 4 | Denmark | |
| 564 | JPRN-UMIN000005358 | 2011/04/01 | 2 April 2019 | Rapid LeukocyAPheresis InDuction for Ulcerative Colitis | ulcerative colitis | LCAP is determined to apply if patient does not obtain a significant improvement (higher than 50%) in spite of recieving sufficient steroid therapy (higher than 30mg/day of prednisolone) for 3 days. LCAP is determined to apply if patient does not obtain a significant improvement (higher than 50%) in spite of recieving sufficient steroid therapy (higher than 30mg/day of prednisolone) for 14 days. | Lower Gastroenterology, Hyogo College of Medicine | Department of Gastroenterology, Osaka City University and Department of Gastroenterology, Osaka Medical College | Not Recruiting | 12years-old | 81years-old | Male and Female | 40 | Phase 2,3 | Japan | |
| 565 | NCT01341808 | April 2011 | 19 February 2015 | Immunogenicity of Hepatitis A Vaccine in Inflammatory Bowel Disease (IBD) Patients | Immunogenicity of Hepatitis A Vaccine in Patients With Inflammatory Bowel Disease | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis;Hepatitis A | Biological: Epaxal Berna (virosomal hepatitis A vaccine) | Asan Medical Center | Not recruiting | 18 Years | 40 Years | Both | 493 | Phase 4 | Korea, Republic of | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 566 | JPRN-UMIN000005033 | 2011/03/01 | 2 April 2019 | Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitis | ulcerative colitis | Patients in tacrolimus only receive tacrolimus twice a day (at initial dose of 0.0025mg/kg, optimal serum traff level 10-15ng/ml (until 2 weeks) , 5-10ng/ml (after 2 weeks)) Patiens in tacrolimus with GMA receive tacrolimus twice a day and two GMA treatments per week. | Saitama Medical Center, Saitama Medical University | Not Recruiting | 12years-old | 75years-old | Male and Female | 50 | Not applicable | Japan | ||
| 567 | NCT00895336 | March 2011 | 16 December 2017 | Lactobacillus GG in Pediatric Ulcerative Colitis (UC) | An Open Label Pilot Study of Lactobacillus GG in Pediatric Ulcerative Colitis | Ulcerative Colitis | Biological: Lactobacillus GG | Children's Hospital Medical Center, Cincinnati | Not recruiting | 5 Years | 18 Years | All | 0 | Phase 2 | United States | |
| 568 | NCT01284062 | March 2011 | 19 October 2017 | Pharmacokinetics/Pharmacodynamics Biomarker Study in Active Ulcerative Colitis Patients | A Phase 2a, Randomized, Double-blind, Sponsor Unblinded, Placebo-controlled, Multiple Dose Study To Evaluate The Pharmacodynamics, Pharmacokinetics And Safety Of Anrukinzumab In Subjects With Active Ulcerative Colitis | Colitis, Ulcerative | Biological: Anrukinzumab;Other: placebo | Pfizer | Not recruiting | 18 Years | 65 Years | All | 84 | Phase 2 | United States;Austria;Bulgaria;Canada;France;Germany;Hungary;Netherlands;Poland;Romania;Spain;Belgium | |
| 569 | NCT01294410 | March 2011 | 3 August 2015 | Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis | A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Ulcerative Colitis (UC) | Colitis, Ulcerative | Drug: Placebo;Drug: Anti-IP-10 Antibody | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | Both | 305 | Phase 2 | United States;Australia;Austria;Belgium;Brazil;Canada;France;Germany;Hungary;Italy;Mexico;Netherlands;Poland;South Africa | |
| 570 | EUCTR2010-023494-19-SE | 10/02/2011 | 23 September 2013 | A Phase IIa, Multi-Centre, Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of K(D)PT after Multiple Ascending Doses in Patients with Active Mild to Moderate Ulcerative Colitis | A Phase IIa, Multi-Centre, Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of K(D)PT after Multiple Ascending Doses in Patients with Active Mild to Moderate Ulcerative Colitis | Ulcerative colitis MedDRA version: 12.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Product Name: Lysine-D-Proline-Threonine Product Code: K(D)PT Pharmaceutical Form: Powder for oral solution Pharmaceutical form of the placebo: Oral liquid Route of administration of the placebo: Oral use | Dr. August Wolff GmbH & Co. KG Arzneimittel | Not Recruiting | Female: yes Male: yes | 12 | Phase 2a | Sweden | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 571 | NCT01240915 | February 2011 | 19 October 2017 | A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis | A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study To Investigate The Safety And Efficacy Of Multistem (Pf-05285401) In Subjects With Moderate To Severe Ulcerative Colitis | Colitis, Ulcerative | Drug: placebo;Drug: MultiStem low dose;Drug: MultiStem high dose | Pfizer | Athersys, Inc | Not recruiting | 18 Years | N/A | All | 105 | Phase 2 | United States;Belgium;Canada;Germany;Hungary;Italy;Slovakia;Sweden |
| 572 | NCT01290042 | February 2011 | 23 March 2015 | Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181. | A Phase 1, Randomized, Double-Blind, Placebo-controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects, in Subjects With Active Ulcerative Colitis, and in Subjects With Active Crohn's Disease. | Ulcerative Colitis;Crohn's Disease | Drug: AMG 181;Other: Placebo for AMG 181 | Amgen | Not recruiting | 18 Years | 65 Years | Both | 43 | Phase 1 | United States;Australia | |
| 573 | NCT01408810 | February 2011 | 19 February 2015 | Evaluation of Histologic and Endoscopic Remission Induced by Infliximab in Moderate to Severe Ulcerative Colitis | Histological and Endoscopic Evaluation of Remission Induced by Infliximab in Moderately to Severely Active Ulcerative Colitis Patients | Ulcerative Colitis | Drug: Infliximab | Grupo de Estudo da Doença Inflamatória Intestinal | Not recruiting | 18 Years | 64 Years | Both | 21 | Phase 4 | Portugal | |
| 574 | EUCTR2010-019558-42-BE | 23/12/2010 | 19 March 2012 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Pilot Study to Assess the Efficacy, Safety, and Tolerability of Baminercept in Subjects With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis MedDRA version: 12.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Product Name: Baminercept Product Code: BG9924 Pharmaceutical Form: Solution for injection INN or Proposed INN: N/A CAS Number: N/A Current Sponsor code: BG9924 Other descriptive name: Baminercept Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | Biogen Idec Ltd. | Not Recruiting | Female: yes Male: yes | 100 | Hungary;Czech Republic;Belgium | ||||
| 575 | JPRN-JapicCTI-101380 | 15/11/2010 | 2 April 2019 | Active Phase Study with MD-0901 -Phase 3 Clinical Trial in Patients with Mild to Moderate Active Ulcerative Colitis- | Active Phase Study with MD-0901 -Phase 3 Clinical Trial in Patients with Mild to Moderate Active Ulcerative Colitis- | Mild to moderate active ulcerative colitis | Intervention name : MD-0901 INN of the intervention : Mesalazine Dosage And administration of the intervention : Mesalazine 2.4 g/d or 4.8 g/d are administrated orally once daily after breakfast for 8 weeks. Control intervention name : Mesalazine tablet INN of the control intervention : Mesalazine Dosage And administration of the control intervention : Mesalazine 2.25 g/d are administrated orally 3 times daily after each meal for 8 weeks. | MOCHIDA PHARMACEUTICAL CO., LTD. | 16 | BOTH | 228 | Phase 3 | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 576 | JPRN-JapicCTI-101381 | 15/11/2010 | 2 April 2019 | Remission Phase Study with MD-0901 -Phase 3 Clinical Trial in Patients with Ulcerative Colitis in Remission Phase- | Remission Phase Study with MD-0901 -Phase 3 Clinical Trial in Patients with Ulcerative Colitis in Remission Phase- | Ulcerative colitis in remission phase | Intervention name : MD-0901 INN of the intervention : Mesalazine Dosage And administration of the intervention : Mesalazine 2.4 g/d are administrated orally once daily after breakfast for 48 weeks. Control intervention name : Mesalazine tablet INN of the control intervention : Mesalazine Dosage And administration of the control intervention : Mesalazine 2.25g/d are administrated orally 3 times daily after each meal for 48 weeks. | MOCHIDA PHARMACEUTICAL CO., LTD. | 16 | BOTH | 190 | Phase 3 | ||||
| 577 | EUCTR2010-019970-33-HU | 11/11/2010 | 25 September 2012 | A multi-centre, double-blind, placebo controlled, parallel group, proof of concept study to evaluate the efficacy, safety and tolerability of KRP203 in subjects with moderately active refractory ulcerative colitis - | Ulcerative colitis MedDRA version: 12.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Product Name: n.a. Product Code: KRP203A Pharmaceutical Form: Capsule* Current Sponsor code: KRP203A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.1- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: n.a Product Code: KRP203A Pharmaceutical Form: Capsule* Current Sponsor code: KRP203A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.4- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: n.a Product Code: KRP203A Pharmaceutical Form: Capsule* Current Sponsor code: KRP203A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Novartis Services AG | Not Recruiting | Female: yes Male: yes | 72 | Hungary;Germany;United Kingdom;Belgium;Sweden | |||||
| 578 | EUCTR2010-018557-35-NL | 08/11/2010 | 19 March 2012 | Desensitisation of ulcerative colitis patients intolerant for mesalazine treatment. - Desensitisation for mesalazine | Desensitisation of ulcerative colitis patients intolerant for mesalazine treatment. - Desensitisation for mesalazine | Ulcerative colitis | Trade Name: Mesalazine Product Name: Mesalazine Product Code: Salofalk Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | University Medical Center Groningen | Authorised | Female: yes Male: yes | 20 | Netherlands | ||||
| 579 | NCT01257386 | November 2010 | 19 February 2015 | Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis | Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis | Active Ulcerative Colitis | Drug: Asacol®;Drug: Mesalazine | Tillotts Pharma AG | Zeria Pharmaceutical | Not recruiting | 18 Years | 64 Years | Both | 251 | Phase 3 | China |
| 580 | NCT01257399 | November 2010 | 19 February 2015 | Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase | Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase | Ulcerative Colitis in Remission | Drug: Asacol®;Drug: Mesalazine | Tillotts Pharma AG | Zeria Pharmaceutical | Not recruiting | 18 Years | 64 Years | Both | 251 | Phase 3 | China |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 581 | NCT01090154 | October 2010 | 18 December 2018 | Study of Cimzia for the Treatment of Ulcerative Colitis | Certolizumab Pegol for the Treatment of Moderate to Severe Ulcerative Colitis: An Open Label Study | Ulcerative Colitis | Drug: Cimzia | University of Washington | UCB Pharma;University of Pennsylvania | Not recruiting | 18 Years | 75 Years | All | 25 | Phase 2 | United States |
| 582 | NCT01111292 | October 2010 | 19 October 2017 | Inositol in Preventing Colorectal Cancer in Patients With Colitis-Associated Dysplasia | Myo-Inositol Chemoprevention in Colitis-Associated Dysplasia | Colon Carcinoma;Dysplasia in Crohn Disease;Low Grade Dysplasia in Ulcerative Colitis;Rectal Carcinoma | Drug: Inositol;Other: Placebo | National Cancer Institute (NCI) | Not recruiting | 18 Years | N/A | All | 5 | Phase 1/Phase 2 | United States | |
| 583 | NCT01130844 | October 2010 | 19 October 2017 | Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis | A Phase 1, Multicenter, Open-label Study to Determine the Safety and Pharmacokinetics of MMX Mesalamine Following Administration in Children and Adolescents With Ulcerative Colitis | Ulcerative Colitis | Drug: MMX Mesalamine | Shire | Not recruiting | 5 Years | 17 Years | All | 52 | Phase 1 | United States;Australia;Poland;Slovakia;United Kingdom | |
| 584 | NCT01201122 | September 2010 | 21 December 2015 | Once Versus Twice Daily Mesalamine to Induce Remission in Pediatric Ulcerative Colitis | Multi Center Ulcerative Colitis Pediatric Pentasa Intervention Trial (MUPPIT). A Randomized, Single-blinded, Controlled, Parallel, Induction Therapy With Once vs. Twice Daily Dosing of Pentasa in Pediatric UC. | Mild to Moderate Ulcerative Colitis | Drug: Mesalamine | Wolfson Medical Center | Not recruiting | 6 Years | 18 Years | Both | 86 | Phase 4 | Israel | |
| 585 | NCT01221428 | September 2010 | 19 February 2015 | Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis | Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative Colitis | Ulcerative Colitis;Mesenchymal Stem Cells;Umbilical Cord | Biological: Umbilical Cord Mesenchymal Stem Cells | Qingdao University | Not recruiting | 18 Years | 70 Years | Both | 50 | Phase 1/Phase 2 | China | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 586 | NCT01320332 | August 2010 | 19 February 2015 | A Study of a Single Dose of ASP3291 in Subjects With Ulcerative Colitis | A Phase 1, Randomized, Double-Blind, Placebo Controlled Study to Assess the Pharmacokinetics, Safety, and Tolerability of ASP3291 Following a Single Oral Dose in Subjects With Ulcerative Colitis | Ulcerative Colitis | Drug: ASP3291;Drug: Placebo | Telsar Pharma Inc. | Not recruiting | 18 Years | 65 Years | Both | 16 | Phase 1 | United States | |
| 587 | JPRN-UMIN000003785 | 2010/07/01 | 2 April 2019 | Remission maintenance treatment of ulcerative colitis with tacrolimus in azathioprine-intolerant patients: a randomized comparative trial of 5-aminosalicylic acid (5-ASA) monotherapy versus 5-ASA and tacrolimus combination therapy. | Ulcerative colitis | 5-aminosalicylic acid monotherapy arm: 5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks). 5-aminosalicylic acid monotherapy and tacrolimus arm: 5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks). Tacrolimus is administered to subjects for 12 weeks after the start of protocol treatment as a rule. | Department of Internal medicine, Division of Lower Gastroenterology, Hyogo College of Medicine | Not Recruiting | 16years-old | 65years-old | Male and Female | 80 | Phase 3 | Japan | ||
| 588 | JPRN-UMIN000003952 | 2010/07/01 | 2 April 2019 | A multicenter, randomised, open-label study to evaluate the clinical efficacy and pharmacokinetics of oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis | ulcerative colitis | Fasting condition group: Tacrolimus ingestion 1 hour before meal Fed condition group: Tacrolimus ingestion immediately following consumption of meal | Department of lower gastroenterology, Hyogo College of Medicine | Osaka Medical College Osaka City University | Not Recruiting | 16years-old | Not applicable | Male and Female | 40 | Phase 4 | Japan | |
| 589 | NCT01164904 | July 2010 | 19 February 2015 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis | A Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: Amg 181 | Amgen | Not recruiting | 18 Years | 55 Years | Both | 72 | Phase 1 | United States;Australia;New Zealand | |
| 590 | NCT01216280 | July 2010 | 19 February 2015 | Efficacy and Tolerability Study of Natura-Alpha in the Treatment of Patients With Active Ulcerative Colitis | Efficacy and Tolerability Study of Natura-Alpha in the Treatment of Patients With Active Ulcerative Colitis | Ulcerative Colitis | Drug: placebo capsule;Drug: 10 mg Natura-alpha capsule and 10 mg placebo capsule;Drug: 2 x 10 mg Natura-alpha capsules | Natrogen Therapeutics International, Inc | Not recruiting | 18 Years | 70 Years | Both | 75 | Phase 2 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 591 | EUCTR2009-017044-13-GB | 30/06/2010 | 16 October 2012 | A study to Evaluate the Ability to Maintain Clinical and Endoscopic Remission During a 12-Month period with 2.4g/day of drug given once a day in adults with ulcerative colitis | A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluate the Effect of Remission Status on the Ability to Maintain or Achieve Clinical and Endoscopic Remission During a 12-Month, Long-term Maintenance Phase With 2.4g/day MMX® Mesalamine/mesalazine Once Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM | Ulcerative Colitis MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: MESALAZINE CAS Number: 89-57-6 Current Sponsor code: SPD476 Other descriptive name: MMX Mesalamine/Mesalazine Concentration unit: g gram(s) Concentration type: equal Concentration number: 1.2- | Shire Development LLC | Authorised | Female: yes Male: yes | 1000 | Phase 3b/4 | United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany | |||
| 592 | NCT01149707 | June 1, 2010 | 11 June 2018 | Safety, Tolerability, Efficacy Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis | A 2-Week Exploratory Randomized, Double-Blind, Parallel-Group, Dose-Ranging, Placebo-Controlled Safety, Tolerability, Biomarker and Efficacy Clinical Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis | Left-Sided Ulcerative Colitis;Proctosigmoiditis | Drug: PUR 0110 Rectal Enema 250 mg;Drug: PUR 0110 Rectal Enema 500 mg;Drug: PUR 0110 Rectal Enema 1000 mg;Drug: Placebo Enema | PurGenesis Technologies Inc. | Not recruiting | 18 Years | 75 Years | All | 34 | Phase 2 | Germany | |
| 593 | EUCTR2009-013890-16-PT | 28/05/2010 | 19 August 2013 | Herica - Histological and Endoscopic evaluation of Remission induced by Infliximab in moderately to severely active ulcerative Colitis Patients - Herica | Herica - Histological and Endoscopic evaluation of Remission induced by Infliximab in moderately to severely active ulcerative Colitis Patients - Herica | This national, multi-centre, open-label pilot study will assess the histologic remission in patients with moderate to severe active ulcerative colitis under infliximab treatment who have had an inadequate response to conventional therapy. Biopsies will be analyzed throughout the study in order to assess histological disease modifying effects in those patients. MedDRA version: 16.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 | Trade Name: Remicade Product Name: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion | GEDII - Grupo de Estudo da Doença inflamatória Intestinal | Not Recruiting | Female: yes Male: yes | 20 | Portugal | ||||
| 594 | EUCTR2009-017839-18-DE | 14/05/2010 | 3 April 2012 | A 2-WEEK EXPLORATORY RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, DOSE-RANGING, PLACEBO-CONTROLLED SAFETY, TOLERABILITY, BIOMARKER AND EFFICACY CLINICAL STUDY OF PUR 0110 RECTAL ENEMA IN MILD-TO-MODERATE DISTAL ULCERATIVE COLITIS | A 2-WEEK EXPLORATORY RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, DOSE-RANGING, PLACEBO-CONTROLLED SAFETY, TOLERABILITY, BIOMARKER AND EFFICACY CLINICAL STUDY OF PUR 0110 RECTAL ENEMA IN MILD-TO-MODERATE DISTAL ULCERATIVE COLITIS | Active mild-to-moderate distal ulcerative colitis MedDRA version: 13.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders | Product Name: PUR 0110 Product Code: PUR 0110 Pharmaceutical Form: Powder for rectal suspension Current Sponsor code: PUR 0110 Other descriptive name: PCT (PureCell Technologies Complex) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Rectal suspension Route of administration of the placebo: Rectal use Product Name: PUR 0110 Product Code: PUR 0110 Pharmaceutical Form: Powder for rectal suspension Current Sponsor code: PUR 0110 Other descriptive name: PCT (PureCell Technologies Complex) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Pharmaceutical form of the placebo: Rectal suspension Route of administration of the placebo: Rectal use Product Name: PUR 0110 Product Code: PUR 0110 Pharmaceutical Form: Powder for rectal suspension Current Sponsor code: PUR 0110 Other descriptive name: PCT (PureCell Technologies Complex) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000- Pharmaceutical form of the placebo: Rectal suspension Route of administration of the placebo: Rectal use | PurGenesis Techonologies Inc. | Not Recruiting | Female: yes Male: yes | 56 | Germany | ||||
| 595 | NCT01033305 | March 2010 | 19 February 2015 | Oral Ciclosporin for Colonic Release in Ulcerative Colitis (CyCol™) | A Phase II, Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapsule Formulation of Ciclosporin (CyCol™) in the Treatment of Mild to Moderate Ulcerative Colitis | Mild to Moderate Ulcerative Colitis | Drug: CyCol™;Drug: Placebo | Sigmoid Pharma | Not recruiting | 18 Years | N/A | Both | 118 | Phase 2 | Ireland;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 596 | NCT01100112 | February 2010 | 19 October 2017 | (CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release Tablets | Multicenter, Open-Label Efficacy and Safety Study of Oral Budesonide-MMX 9mg Extended Release Tablets in Patients With Mild to Moderate, Active Ulcerative Colitis | Colitis, Ulcerative | Drug: Budesonide | Valeant Pharmaceuticals International, Inc. | Cosmo Technologies Ltd | Not recruiting | 18 Years | 75 Years | All | 61 | Phase 3 | India |
| 597 | NCT01037322 | January 2010 | 19 February 2015 | Cannabidiol for Inflammatory Bowel Disease | Use of Cannabidiol for the Treatment of Inflammatory Bowel Disease | Crohn's Disease;Ulcerative Colitis | Drug: cannabidiol;Drug: placebo in drops | Meir Medical Center | Not recruiting | 20 Years | 80 Years | Both | 20 | Phase 1/Phase 2 | Israel | |
| 598 | NCT01040910 | January 2010 | 19 February 2015 | Cannabis for Inflammatory Bowel Disease | A Double Blind Placebo Controlled Study of Cannabis Smoking in Inflammatory Bowel Disease | Crohn's Disease;Ulcerative Colitis | Drug: smoking of cannabis;Drug: smoking cigarettes with placebo | Meir Medical Center | Recruiting | 20 Years | 70 Years | Both | 20 | Phase 1/Phase 2 | Israel | |
| 599 | NCT01065571 | January 2010 | 19 February 2015 | Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity | Effects of Carrageenan-Elimination Diet on Ulcerative Colitis Disease Activity | Ulcerative Colitis | Dietary Supplement: carrageenan;Other: dietary intervention with no-carrageenan diet | University of Illinois at Chicago | The Broad Foundation;University of Chicago | Recruiting | 18 Years | N/A | Both | 40 | N/A | United States |
| 600 | EUCTR2008-005237-30-NL | 01/12/2009 | 7 December 2015 | A Multicenter, Prospective, Long-term Registry of children with Crohn's Disease or Ulcerative Colitis | A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease or Ulcerative Colitis - DEVELOP | Pediatric patients with a confirmed diagnosis of CD or UC . MedDRA version: 18.1 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Remicade Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Other descriptive name: Remsima and Inflectra Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Janssen Biologics B.V. | Authorised | Female: yes Male: yes | 6000 | United States;Canada;Netherlands;Sweden | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 601 | NCT01039597 | December 2009 | 19 February 2015 | Safety and Activity of ORE1001 in Subjects With Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled Pilot Study of the Safety and Therapeutic Activity of ORE1001 in Subjects With Ulcerative Colitis | Mild to Moderate Ulcerative Colitis | Drug: ORE1001;Drug: Placebo | Ore Pharmaceuticals, Inc. | Recruiting | 18 Years | 70 Years | Both | 50 | Phase 1/Phase 2 | Canada;India | |
| 602 | EUCTR2009-015077-12-GB | 23/11/2009 | 9 October 2012 | The use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasia | The use of corticosteroids (Budenofalk) as a chemopreventative agent in ulcerative colitis associated neoplasia - | chronic ulcerative colitis ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Budenofalk 2mg rectal foam Product Name: Budenofalk rectal foam Pharmaceutical Form: Rectal foam | University Hospital Birmingham NHS Foundation Trust | Authorised | Female: yes Male: yes | 50 | United Kingdom | ||||
| 603 | EUCTR2009-015136-14-BE | 20/11/2009 | 19 March 2012 | Modified release metronidazole for the treatment of pouchitis after colectomy with ileo-anal pouch anastomosis for ulcerative colitis: a pharmacokinetic study | Modified release metronidazole for the treatment of pouchitis after colectomy with ileo-anal pouch anastomosis for ulcerative colitis: a pharmacokinetic study | Pouchitis MedDRA version: 12.0 Level: LLT Classification code 10036463 Term: Pouchitis | Product Name: Metronidazole capsule 50 mg Product Code: FP-110 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Metronidazole CAS Number: 44-348-1 Current Sponsor code: Fp-110 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Name: Flagyl Pharmaceutical Form: Coated tablet INN or Proposed INN: Metronidazole CAS Number: 443-38-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- | FORMAC Pharmaceuticals NV | Not Recruiting | Female: yes Male: yes | Belgium | |||||
| 604 | EUCTR2008-007952-90-DE | 17/11/2009 | 19 March 2012 | A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis. - Amendment No. 3 (Version 1.0), 16-JUL-2010 | A randomized, multi-center, doubleblind, parallel group, placebocontrolled, phase IIb, dose ranging study to investigate the efficacy and safety of LT-02 in patients with mesalazine-refractory ulcerative colitis. - Amendment No. 3 (Version 1.0), 16-JUL-2010 | Patients with ulcerative colitis (UC) according to European Crohn's and Colitis Organisation (ECCO) consensus; Simple Clinical Colitis Activity Index (SCCAI) =5 and SCCAI subscore for “blood in stool” =2 at Baseline Visit. MedDRA version: 12.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Product Name: LT-02 (modified-release PC pellets) Product Code: LT-02 Pharmaceutical Form: Granules for oral suspension INN or Proposed INN: Modified-release phosphatidylcholine Concentration unit: g gram(s) Concentration type: equal Concentration number: 0.2- Pharmaceutical form of the placebo: Granules for oral suspension Route of administration of the placebo: Oral use Product Name: LT-02 (modified-release PC pellets) Product Code: LT-02 Pharmaceutical Form: Granules for oral suspension INN or Proposed INN: Modified-release phosphatidylcholine Concentration unit: g gram(s) Concentration type: equal Concentration number: 0.4- Pharmaceutical form of the placebo: Granules for oral suspension Route of administration of the placebo: Oral use Product Name: LT-02 (modified-release PC pellets) Product Code: LT-02 Pharmaceutical Form: Granules for oral suspension INN or Proposed INN: Modified-release phosphatidylcholine Concentration unit: g gram(s) Concentration type: equal Concentration number: 0.8- Pharmaceutical form of the placebo: Granules for oral suspension Route of administration of the placebo: Oral use | Lipid Therapeutics GmbH | Not Recruiting | Female: yes Male: yes | 240 | Phase 2b | Germany;Lithuania | |||
| 605 | EUCTR2008-003169-19-IE | 09/11/2009 | 11 September 2012 | A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative Colitis | A Randomized, Double-blind, Placebo-controlled Study of a Controlled Release Minicapusle Formulation of Ciclosporin (CyCol™) in the Treatment of Ulcerative Colitis | Ulcerative colitis MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis ;Ulcerative colitis MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Product Name: CyCol Pharmaceutical Form: Modified-release capsule, hard INN or Proposed INN: ciclosporin CAS Number: 59865-13-3 Current Sponsor code: ciclosporin Other descriptive name: cyclosporine (USAN) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Pharmaceutical Form: Modified-release capsule, hard INN or Proposed INN: ciclosporin CAS Number: 59865-13-3 Current Sponsor code: ciclosporin Other descriptive name: cyclosporine (USAN) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Sigmoid Pharma Ltd | Not Recruiting | Female: yes Male: yes | 0 | United Kingdom;Ireland | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 606 | NCT01020708 | November 2009 | 19 February 2015 | Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis | A Phase I Double-blind, Randomized, Comparator-controlled Study of the Safety and Tolerability of N-acetylcysteine Plus Mesalamine Enema in Subjects With Left-sided Ulcerative Colitis | Ulcerative Colitis | Drug: mesalamine;Drug: ALTH12-1:4;Drug: ALTH12-2:4 | Altheus Therapeutics, Inc. | Not recruiting | 18 Years | 64 Years | Both | 9 | Phase 1 | United States | |
| 607 | NCT01059344 | November 2009 | 16 December 2017 | Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis | A Randomized Placebo-Controlled Double-Blind Study to Evaluate the Efficacy and Safety of Asacol™ 4.8 g/Day (800 mg Tablets) for the Treatment of Active Ulcerative Colitis | Ulcerative Colitis | Drug: Mesalamin | Tillotts Pharma AG | Not recruiting | 18 Years | N/A | All | 281 | Phase 3 | Belarus;India;Turkey;Ukraine | |
| 608 | EUCTR2009-015649-21-NO | 21/10/2009 | 19 March 2012 | Immunmodulating and clinical effect of vitamin D onthe induction of remission in the patients with moderate to severe ulcerative colitis under the treatment with Infliximab. | Immunmodulating and clinical effect of vitamin D onthe induction of remission in the patients with moderate to severe ulcerative colitis under the treatment with Infliximab. | Ulcerative colitis | Trade Name: Dekristol Product Name: cholecalciferol Product Code: na Pharmaceutical Form: Capsule, soft Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use | Medical clinic, University Hospital of North Norway | Authorised | Female: yes Male: yes | 200 | Norway | ||||
| 609 | NCT03747068 | October 9, 2009 | 3 December 2018 | The Influence of Biologcal Treatment on the Short-Term Complications of Surgery in Patients With Inflematory Bowel Disease. | Preoperative Use of ANTI-Tumor Necrosis Factor Therapy in Ulcerative Colitis Patients Who Underwent Ileal Pouch-Anal Anastomosis (IPAA) is Not Associated With Histological Fibrosis | Ulcerative Colitis;Anti TNF Therapy;Ileal Pouch Anal Anastomosis (IPAA) | Drug: Anti-TNF Drug | HaEmek Medical Center, Israel | Mount Sinai Hospital, Canada;University of Toronto | Not recruiting | N/A | N/A | All | 130 | N/A | |
| 610 | NCT01004185 | October 2009 | 19 October 2017 | Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis | A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8g/Day) 400 mg Delayed-release Tablets Given Twice Daily for 26 Weeks to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis | Ulcerative Colitis | Drug: Asacol 400 mg | Warner Chilcott | Not recruiting | 5 Years | 17 Years | All | 39 | Phase 3 | United States;Canada;Croatia;Poland;Romania;Russian Federation | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 611 | EUCTR2009-010921-38-NL | 08/09/2009 | 19 March 2012 | Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis: A Double-blind, Randomized Placebo-controlled Pilot Study - CRC chemoprevention in UC | Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis: A Double-blind, Randomized Placebo-controlled Pilot Study - CRC chemoprevention in UC | Ulcerative Colitis and the risk of developing colorectal cancer. MedDRA version: 13.1 Level: PT Classification code 10021972 Term: Inflammatory bowel disease System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Salofalk Pharmaceutical Form: Granules INN or Proposed INN: mesalazine CAS Number: 89-57-6 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 20-25 Pharmaceutical form of the placebo: Granules Route of administration of the placebo: Oral use Trade Name: Ursofalk Pharmaceutical Form: Coated tablet INN or Proposed INN: ursodeoxycholic acid CAS Number: 128-13-2 Concentration unit: g gram(s) Concentration type: equal Concentration number: 4- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use | UMC Utrecht | Authorised | Female: yes Male: yes | Netherlands | |||||
| 612 | NCT01036022 | September 1, 2009 | 16 December 2017 | Effect of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis | A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients With Mild to Moderately Active Ulcerative Colitis | Colitis, Ulcerative | Drug: GSK1399686 | GlaxoSmithKline | Not recruiting | 18 Years | 65 Years | All | 120 | Phase 2 | Belgium;Canada;Germany;Norway;Sweden | |
| 613 | NCT02322008 | September 2009 | 19 February 2015 | Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice | Anti-TNF Therapy in Danish Patients With Inflammatory Bowel Diseases in Clinical Practice | Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease | Biological: infliximab and adalimumab | Regionshospitalet Viborg, Skive | Not recruiting | 18 Years | N/A | Both | 1035 | N/A | ||
| 614 | EUCTR2009-010065-23-DE | 17/08/2009 | 1 May 2012 | Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX | Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX | Active Moderate to Severe Ulcerative Colitis MedDRA version: 14.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: LLT Classification code 10033007 Term: Other ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: LLT Classification code 10045366 Term: Ulcerative colitis, unspecified System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: infliximab Other descriptive name: 100 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: Pentasa 500 mg Retardtabletten Product Name: 5-Aminosalicylic acid (5-ASA) Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: 5-Aminosalicylic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Trade Name: Imurek 25mg Filmtabletten Pharmaceutical Form: Coated tablet INN or Proposed INN: azathioprine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Trade Name: Imurek 50mg Filmtabletten Pharmaceutical Form: Coated tablet INN or Proposed INN: azathioprine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Name: Decortin H 1 mg Pharmaceutical Form: Tablet INN or Proposed INN: prednisolone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Trade Name: Decortin H 5mg Pharmaceutical Form: Tablet INN or Proposed INN: prednisolone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Trade Name: Decortin H 10mg Pharmaceutical Form: Tablet INN or Proposed INN: prednisolone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Trade Name: Decortin H 20mg Pharmaceutical Form: Tablet INN or Proposed INN: prednisolone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Trade Name: Decortin H 50 mg Pharmaceutical Form: Tablet INN or Proposed INN: prednisolone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | Essex Pharma GmbH | Not Recruiting | Female: yes Male: yes | Phase 3 | Germany | ||||
| 615 | EUCTR2009-011608-51-SE | 17/08/2009 | 29 April 2013 | A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis | A Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-Inflammatory Effects of GSK1399686 in Patients with Mild to Moderately Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Product Name: GSK1399686 Product Code: GSK1399686 Pharmaceutical Form: Capsule, hard Current Sponsor code: GSK1399686 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: ASACOL Product Name: ASACOL Product Code: ASACOL Pharmaceutical Form: Over encapsulated tablet INN or Proposed INN: mesalazine Current Sponsor code: Asacol Other descriptive name: Overencapsulated mesalazine tablets Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Over encapsulated tablet Route of administration of the placebo: Oral use Product Name: GSK1399686 Product Code: GSK1399686 Pharmaceutical Form: Capsule, hard Current Sponsor code: GSK1399686 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: GSK1399686 Product Code: GSK1399686 Pharmaceutical Form: Capsule, hard Current Sponsor code: GSK1399686 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: GSK1399686 Product Code: GSK1399686 Pharmaceutical Form: Capsule, hard Current Sponsor code: GSK1399686 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | GlaxoSmithKline Research and Development Ltd | Not Recruiting | Female: yes Male: yes | 60 | Germany;Sweden | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 616 | NCT00963287 | August 2009 | 2 May 2016 | Trial of Chinese Prescription on Ulcerative Colitis | Ulcerative Colitis | Drug: bascial prescription plus or minus herbs depend on symptoms | Shanghai University of Traditional Chinese Medicine | Not recruiting | 18 Years | 65 Years | Both | 200 | N/A | China | ||
| 617 | NCT01149694 | June 2009 | 19 February 2015 | A Study to Assess the Safety and Tolerability of PUR 0110 Rectal Enema in Normal Healthy Volunteers | A Randomized, Double-Blind, Parallel-Group, Single-Ascending Dose, Placebo-Controlled Safety and Tolerability Study of PUR 0110 Rectal Enema in Normal Healthy Volunteers | Ulcerative Colitis | Drug: PUR 0110 Rectal Enema or Placebo Enema | PurGenesis Technologies Inc. | Not recruiting | 18 Years | 55 Years | Male | 24 | Phase 1 | Germany | |
| 618 | EUCTR2008-003913-28-IT | 25/05/2009 | 19 March 2012 | Randomised, double-blind,multicentre,12 months extension study to evaluate the safety and the efficacy of daily Budesonide MMX 6mg vs placebo in the maintenance of remission in subjects with ulcerative colitis. - ND | Randomised, double-blind,multicentre,12 months extension study to evaluate the safety and the efficacy of daily Budesonide MMX 6mg vs placebo in the maintenance of remission in subjects with ulcerative colitis. - ND | Mild to moderate ulcerative colitis. MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Product Name: Budesonide-MMX Product Code: CB-01-02 Pharmaceutical Form: Tablet INN or Proposed INN: Budesonide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 6- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | COSMO TECHNOLOGIES LTD | Not Recruiting | Female: yes Male: yes | 150 | Italy | ||||
| 619 | NCT00790933 | May 22, 2009 | 26 February 2018 | An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Subjects With Ulcerative Colitis and Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: Vedolizumab | Takeda | Not recruiting | 18 Years | N/A | All | 2243 | Phase 3 | United States;Australia;Belgium;Canada;Czechia;Germany;Hungary;Israel;Korea, Republic of;Malaysia;Czech Republic | |
| 620 | NCT00889161 | May 2009 | 19 February 2015 | Curcumin in Pediatric Inflammatory Bowel Disease | Curcumin in Pediatric Inflammatory Bowel Disease: A Forced Dose Titration Study | Inflammatory Bowel Disease;Ulcerative Colitis;Crohn's Disease | Drug: Curcumin | Seattle Children's Hospital | Not recruiting | 8 Years | 18 Years | Both | 11 | Phase 1 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 621 | EUCTR2008-002784-14-EE | 28/04/2009 | 5 February 2018 | An Open-label Study of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | A Phase 3, Open-label Study to Determine the Long-Term Safety and Efficacy of Vedolizumab (MLN0002) in Patients with Ulcerative Colitis and Crohn’s Disease | Ulcerative Colitis and Crohn’s Disease MedDRA version: 14.1 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: VEDOLIZUMAB Product Code: MLN0002 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: VEDOLIZUMAB CAS Number: 943609-66-3 Current Sponsor code: MLN0002 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- | Millennium Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 2200 | Phase 3 | Portugal;Serbia;United States;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Ukraine;Ireland;South Africa;Netherlands;Latvia;Korea, Republic of;Turkey;Austria;Malta;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Singapore;Romania;Bulgaria;Iceland;Germany;Norway;New Zealand;Sweden;Israel;Russian Federation;Italy;Switzerland;India;France;Malaysia;Australia | |||
| 622 | EUCTR2008-007519-34-SE | 17/04/2009 | 19 March 2012 | Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSION | Feasibility of Accelerated infliximab infusions - Safety and Tolerability in patients wit IBD. FAST - FAST VERSION | This is a open label, prospective, multicenter trial in patients recieving one hour infusions of infliximab (i.e. Remicade)as part of their daily practice. Main objective: Is to assess the tolerability of Remicade with an infusionsrate of 30 minutes. Patients: eligible patients are those with intestinal fistulas Mb Crohn disease or Ulcerative colitis/IBD. or patietns with | Trade Name: Remicade Pharmaceutical Form: Powder and solvent for solution for infusion | University of Leuven Hospitals, Division of Gastroenterology | Authorised | Female: yes Male: yes | 200 | Sweden | ||||
| 623 | NCT01287195 | April 7, 2009 | 16 December 2017 | Oral OKT3 for the Treatment of Active Ulcerative Colitis | Oral Anti-CD3 for the Treatment of Active Ulcerative Colitis | Ulcerative Colitis | Drug: Oral OKT3;Drug: Omeprazole | Brigham and Women's Hospital | Not recruiting | 18 Years | 65 Years | All | 6 | Phase 1/Phase 2 | United States | |
| 624 | EUCTR2008-007292-25-IT | 24/03/2009 | 19 March 2012 | AN OPEN, PILOT PHASE III, RANDOMIZED CLINICAL TRIAL TO ASSESS THE TISSUTAL PHARMAKINETICS OF MESALAZINE TABLETS IN PATIENTS WITH MILD TO MODERATE LEFT-SIDED ULCERATIVE COLITIS IN ACTIVE PHASE - GIU-5-ASA1.2 MMx-02-08 | AN OPEN, PILOT PHASE III, RANDOMIZED CLINICAL TRIAL TO ASSESS THE TISSUTAL PHARMAKINETICS OF MESALAZINE TABLETS IN PATIENTS WITH MILD TO MODERATE LEFT-SIDED ULCERATIVE COLITIS IN ACTIVE PHASE - GIU-5-ASA1.2 MMx-02-08 | Patients with established diagnosis of left-sided UC (rectum-sigmoid colon or colon up to the splenic flexure) MedDRA version: 9.1 Level: LLT Classification code 10024123 Term: Left-sided ulcerative (chronic) colitis | Trade Name: MEZAVANT Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Mesalazine Concentration unit: g gram(s) Concentration type: equal Concentration number: 1.2- Trade Name: ASACOL Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: Mesalazine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 800- | GIULIANI | Not Recruiting | Female: yes Male: yes | Phase 3 | Italy | ||||
| 625 | EUCTR2008-002782-32-ES | 02/03/2009 | 28 August 2014 | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis Estudio multicéntrico, ciego, controlado con placebo, aleatorizado, de fase 3, sobre la inducción y el mantenimiento de la respuesta clínica y la remisión con MLN0002, en pacientes con colitis ulcerosa moderada o grave | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients with Moderate to Severe Ulcerative Colitis Estudio multicéntrico, ciego, controlado con placebo, aleatorizado, de fase 3, sobre la inducción y el mantenimiento de la respuesta clínica y la remisión con MLN0002, en pacientes con colitis ulcerosa moderada o grave | Moderate to Severe Ulcerative Colitis Colitis ulcerosa moderada o grave MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Product Name: VEDOLIZUMAB Product Code: MLN0002 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: VEDOLIZUMAB CAS Number: 943609-66-3 Current Sponsor code: MLN0002 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Millennium Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Estonia;Greece;Spain;Ireland;Austria;Malta;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Germany;Latvia;Netherlands;Iceland | |||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 626 | JPRN-JapicCTI-090718 | 01/2/2009 | 2 April 2019 | A Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis. | A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects with Moderately to Severely Active Ulcerative Colitis. | Ulcerative colitis | Intervention name : adalimumab INN of the intervention : adalimumab Dosage And administration of the intervention : 160/80 mg at Week 0/2 and 40 mg eow starting at Week 4 to Week 50, or 80/40 mg at Week 0/2 and 40 mg eow starting at Week 4 to Week 50 Control intervention name : Placebo Dosage And administration of the control intervention : Placebo eow starting at Week 0 to Week 50 | AbbVie GK | Eisai Co., Ltd. | 15 | BOTH | 255 | Phase 2-3 | |||
| 627 | NCT00853099 | February 2009 | 19 October 2017 | A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | A Multi-Center, Randomized, Double-Blind, Placebo-controlled Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis. | Ulcerative Colitis | Biological: adalimumab;Drug: placebo | AbbVie (prior sponsor, Abbott) | Eisai Co., Ltd. | Not recruiting | 15 Years | N/A | All | 274 | Phase 3 | Japan |
| 628 | EUCTR2008-004564-40-IT | 23/01/2009 | 28 August 2012 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - ND | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS - ND | CP-690,550 is being developed for the treatment of patients with moderate-to-severe ulcerative colitis. MedDRA version: 9.1 Level: LLT Classification code 10045282 Term: UC | Product Name: CP-690,550 Pharmaceutical Form: Tablet CAS Number: 540737-29-9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: CP-690,550 Pharmaceutical Form: Tablet CAS Number: 540737-29-9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: CP-690,550 Pharmaceutical Form: Tablet CAS Number: 540737-29-9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | PFIZER | Not Recruiting | Female: yes Male: yes | 200 | Hungary;Czech Republic;Slovakia;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden | ||||
| 629 | EUCTR2008-005903-25-DE | 08/01/2009 | 4 March 2013 | Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis) | Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis) | inflammatory bowel disease (Crohn’s disease and ulcerative colitis) MedDRA version: 12.0 Level: LLT Classification code 10021973 Term: Inflammatory bowel disease NOS | Product Name: SC12267 Product Code: SC12267 Pharmaceutical Form: Film-coated tablet Current Sponsor code: SC12267 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 35- Trade Name: Prednisolon Jenapharm Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Prednisolon CAS Number: 50-24-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Trade Name: Prednisolon Jenapharm Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Prednisolon CAS Number: 50-24-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Trade Name: Prednisolon Jenapharm Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Prednisolon CAS Number: 50-24-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- | 4SC AG | Not Recruiting | Female: yes Male: yes | 35 | Bulgaria;Germany | ||||
| 630 | JPRN-UMIN000008967 | 2009/01/01 | 2 April 2019 | Efficacy of zinc-carnosine chelate compound, Polaprezinc, enemas in patients with ulcerative colitis | Ulcerative Colitis | Polaprezinc group: Polaprezinc enema contained 150 mg of Polaprezinc suspension in tap water (total volume 100 mL) daily for one week Placebo group: 100 mL tap water enema daily for one week | The Jikei University School of Medicine Division of Gastroenterology and Hepatology | Not Recruiting | 18years-old | Not applicable | Male and Female | 30 | Not applicable | Japan | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 631 | NCT00748410 | January 2009 | 16 December 2017 | Study to Evaluate the Pharmacodynamics of SB-656933 in Patients With Ulcerative Colitis | An Open Label, 7-day Repeat Dose Study to Evaluate the Pharmacodynamics of SB-656933-AAA in Patients With Ulcerative Colitis. | Colitis, Ulcerative | Drug: SB-656933 | GlaxoSmithKline | Not recruiting | N/A | N/A | All | 3 | Phase 2 | Netherlands | |
| 632 | NCT00783718 | January 2009 | 19 October 2017 | Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by MLN0002 in Patients With Moderate to Severe Ulcerative Colitis | Ulcerative Colitis | Drug: vedolizumab;Other: Placebo | Millennium Pharmaceuticals, Inc. | Not recruiting | 18 Years | 80 Years | All | 895 | Phase 3 | United States;Canada;Puerto Rico | |
| 633 | NCT00790478 | January 2009 | 19 February 2015 | Melatonin & Ulcerative Colitis | Melatonin and Ulcerative Colitis: A Pilot Clinical Trial | Ulcerative Colitis | Dietary Supplement: Melatonin;Other: Placebo | Emory University | Recruiting | 18 Years | 69 Years | Both | 60 | Phase 2 | United States | |
| 634 | JPRN-JapicCTI-090739 | 08/12/2008 | 23 April 2019 | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Intervention name : golimumab Dosage And administration of the intervention : SC | JANSSEN PHARMACEUTICAL K.K | 18 | BOTH | Phase 2-3 | |||||
| 635 | JPRN-JapicCTI-090740 | 08/12/2008 | 23 April 2019 | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Intervention name : golimumab Dosage And administration of the intervention : SC | JANSSEN PHARMACEUTICAL K.K | 18 | BOTH | Phase 3 | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 636 | EUCTR2008-004610-27-BE | 02/12/2008 | 19 March 2012 | A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis | A double-blind, randomised, placebo and mesalazine controlled phase II study to explore the safety and activity of dersalazine in patients with mild to moderate active colitis | Mild to moderate active ulcerative colitis MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Product Name: Dersalazine sodium Product Code: UR-12746-S Pharmaceutical Form: Capsule* INN or Proposed INN: dersalazine sodium CAS Number: 367249-56-7 Current Sponsor code: UR-12746-S Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: Lixacol Product Name: Lixacol Pharmaceutical Form: Over encapsulated tablet INN or Proposed INN: Mesalazine CAS Number: 89576 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: Lixacol Product Name: Lixacol Pharmaceutical Form: Coated tablet INN or Proposed INN: mesalazine CAS Number: 89576 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- | Palau Pharma S.A. | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;Belgium;Spain | |||
| 637 | NCT00713310 | December 2008 | 19 October 2017 | Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis | Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8 g/Day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents With Mildly-to-Moderately Active Ulcerative Colitis | Ulcerative Colitis | Drug: Asacol 400 mg | Warner Chilcott | Not recruiting | 5 Years | 17 Years | All | 83 | Phase 3 | United States;Canada;Croatia;Poland;Romania | |
| 638 | NCT00787202 | December 2008 | 19 October 2017 | A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis. | A Randomized, Placebo Controlled, Double Blind, Parallel Group Multi-Center Study In Order To Investigate Safety And Efficacy Of CP- 690 550 In Subjects With Moderate To Severe Ulcerative Colitis. | Ulcerative Colitis | Drug: CP- 690 550;Other: placebo | Pfizer | Not recruiting | 18 Years | N/A | All | 195 | Phase 2 | Belgium;Brazil;Chile;Czech Republic;Denmark;France;Hungary;Israel;Italy;Mexico;Netherlands;Poland;Slovakia;South Africa;Spain;Sweden;United Kingdom;Turkey | |
| 639 | NCT00801723 | December 2008 | 19 February 2015 | (CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis. | Randomised, Double-Blind, Multi-Centre, 12 Month Extension Study to Evaluate the Safety And Efficacy of Daily Budesonide MMX 6 mg Versus Placebo in the Maintenance of Remission in Subjects With Ulcerative Colitis. | Ulcerative Colitis | Drug: Budesonide MMX 6 mg Tablet;Drug: Placebo Tablet | Salix Pharmaceuticals | Not recruiting | 18 Years | 75 Years | Both | 123 | Phase 3 | United States;Canada | |
| 640 | EUCTR2006-003607-40-NL | 13/11/2008 | 19 March 2012 | A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN STEROID-REFRACTORY ULCERATIVE COLITIS - METEOR | A CONTROLLED, RANDOMISED, DOUBLE-BLIND, MULTICENTER STUDY, COMPARING METHOTREXATE VS PLACEBO IN STEROID-REFRACTORY ULCERATIVE COLITIS - METEOR | Steroid-dependent ulcerative colitis | Trade Name: methotrexate bellon Product Name: methotrexate bellon 25mg/ml Pharmaceutical Form: Solution for injection INN or Proposed INN: methotrexate bellon 25mg/ml CAS Number: 59 05 2 Current Sponsor code: Sonifi Aventis Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intramuscular use | Besancon University Hospital | Not Recruiting | Female: yes Male: yes | 110 | Finland;Netherlands;Austria | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 641 | EUCTR2008-000967-40-NL | 03/11/2008 | 19 March 2012 | A Phase 2a Randomised, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderatley Active Ulcerative Colitis | A Phase 2a Randomised, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderatley Active Ulcerative Colitis | Moderately Active Ulcerative Colitis MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Product Name: AG011 - Enema Product Code: AG011 Pharmaceutical Form: Powder for rectal suspension Current Sponsor code: AG011-DS-01 Concentration unit: CFU/g colony forming unit(s)/gram Concentration type: range Concentration number: 0.6 x 10e10-1.0 x 10e10 Pharmaceutical form of the placebo: Powder for rectal suspension Route of administration of the placebo: Rectal use Product Name: AG011 - Capsules Product Code: AG011 Pharmaceutical Form: Gastro-resistant capsule, soft Current Sponsor code: AG011-DS-01 Concentration unit: CFU/g colony forming unit(s)/gram Concentration type: range Concentration number: 1.94 x 10e10-3.2 x 10e10 Pharmaceutical form of the placebo: Gastro-resistant capsule, hard Route of administration of the placebo: Oral use Product Name: AG011 - Enema Product Code: AG011 Pharmaceutical Form: Powder for rectal suspension Current Sponsor code: AG011-DS-01 Concentration unit: CFU/g colony forming unit(s)/gram Concentration type: range Concentration number: 0.6 x 10e11-1.0 x 10e11 Pharmaceutical form of the placebo: Powder for rectal suspension Route of administration of the placebo: Rectal use Product Name: AG011 - Enema Product Code: AG011 Pharmaceutical Form: Powder for rectal suspension Current Sponsor code: AG011-DS-01 Concentration unit: CFU/g colony forming unit(s)/gram Concentration type: range Concentration number: 0.3 x 10e12-0.5 x 10e12 Pharmaceutical form of the placebo: Powder for rectal suspension Route of administration of the placebo: Rectal use Product Name: AG011 - Capsules Product Code: AG011 Pharmaceutical Form: Gastro-resistant capsule, hard Current Sponsor code: AG011-DS-01 Concentration unit: CFU/g colony forming unit(s)/gram Concentration type: range Concentration number: 1.94 x 10e11-3.2 x 10e11 Pharmaceutical form of the placebo: Gastro-resistant capsule, hard Route of administration of the placebo: Oral use | ActoGeniX NV. | Authorised | Female: yes Male: yes | 60 | Phase 2a | Netherlands;Belgium;Sweden | |||
| 642 | NCT00793130 | November 2008 | 19 February 2015 | The Efficacy and Tolerability of Coltect as Add-on in Patients With Active Ulcerative Colitis - an Open Label | The Efficacy and Tolerability of Coltect as Add-on in Patients With Active Ulcerative Colitis - an Open Label | Ulcerative Colitis | Dietary Supplement: Coltect | Tel-Aviv Sourasky Medical Center | Recruiting | 18 Years | 75 Years | Both | 30 | N/A | Israel | |
| 643 | EUCTR2007-002544-25-CZ | 21/10/2008 | 19 March 2012 | A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis | A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (anti-CXCL10 Human Monoclonal Antibody) in Subjects with Active Ulcerative Colitis | Active Ulcerative Colitis MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Product Name: MDX-1100 Product Code: MDX-1100 Pharmaceutical Form: Solution for infusion Current Sponsor code: MDX-1100 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Bristol-Myers Squibb International Corporation | Not Recruiting | Female: yes Male: yes | 106 | Phase 2 | Hungary;Czech Republic;Latvia | |||
| 644 | EUCTR2007-005520-32-NL | 01/10/2008 | 19 March 2012 | An open label, 7-day repeat dose study to evaluate the pharmacodynamics of SB-656933-AAA in patients with Ulcerative Colitis. | An open label, 7-day repeat dose study to evaluate the pharmacodynamics of SB-656933-AAA in patients with Ulcerative Colitis. | ulcerative colitis MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Product Name: SB-656933 Tablets Product Code: SB-656933 Pharmaceutical Form: Film-coated tablet Current Sponsor code: SB-656933 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Current Sponsor code: SB-656933 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | GlaxoSmithKline R&D Ltd | Not Recruiting | Female: yes Male: yes | Netherlands | |||||
| 645 | NCT00751933 | October 2008 | 19 October 2017 | Vaccines and Dietary Oats in the Treatment of Ulcerative Colitis | A Controlled Study of Salmonella Ty21a and Cholera/ ETEC-vaccine and the Role of Oats in Daily Diet as a New Treatment in Patients With Mild or Moderate Ulcerative Colitis. | Ulcerative Colitis | Biological: Vaccine Vivotif + Vaccine Dukoral + oats;Biological: Vaccine Vivotif + Vaccine Dukoral;Dietary Supplement: Oats;Other: Placebo | Haukeland University Hospital | Helse Vest | Not recruiting | 18 Years | 80 Years | All | 3 | Phase 2 | Norway |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 646 | NCT00791557 | October 2008 | 19 October 2017 | Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease | An Open Label Single Center Pilot Study Investigating the Clinical Response and Mechanism of Action of Infliximab in the Treatment of Adults With Inflammatory Bowel Disease Who Have Moderate to Severe Pyoderma Gangrenosum | Pyoderma Gangrenosum;Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease | Drug: Infliximab | University Hospitals Cleveland Medical Center | Centocor, Inc. | Not recruiting | 18 Years | 75 Years | All | 2 | N/A | United States |
| 647 | NCT00805285 | October 2008 | 19 October 2017 | The Use of Oral Budesonide and Rectal Hydrocortisone for the Treatment of Active Ulcerative Colitis | Oral Budesonide and Rectal Hydrocortisone for the Treatment of Extensive Ulcerative Colitis: A Pilot Study | Inflammatory Bowel Disease;Ulcerative Colitis | Drug: Combination Oral Budesonide and Rectal Hydrocortisone | University of Maryland | Not recruiting | 18 Years | N/A | All | 2 | Phase 2 | United States | |
| 648 | NCT00810030 | October 2008 | 19 February 2015 | FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-COR | Select A Multi-centre Randomised Prospective Open-label Study to Investigate the Efficacy & Safety of a Standardised Correction Dosage Regimen of i.v. Ferric Carboxymaltose Versus Iron Sucrose for Treatment of Iron Deficiency Anaemia in Patients With Inflammatory Bowel Disease | Inflammatory Bowel Disease;Anemia;Iron Deficiency;Iron-Deficiency Anemia;Crohn's Disease;Ulcerative Colitis | Drug: Ferric carboxymaltose;Drug: Iron Sucrose | Vifor Inc. | Parexel;ClinStar | Not recruiting | 18 Years | N/A | Both | 484 | Phase 3 | Austria;Russian Federation |
| 649 | NCT00652145 | September 2008 | 19 October 2017 | Dose Escalation and Remission (DEAR) | Test Treat Strategy to Prevent Ulcerative Colitis Relapse | Ulcerative Colitis | Drug: mesalamine | James Lewis | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);Shire | Not recruiting | 18 Years | N/A | All | 119 | Phase 4 | United States |
| 650 | NCT00694980 | September 2008 | 14 November 2016 | A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis | A Phase I, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous and Subcutaneous rhuMAb Beta7 Administered in a Single-Dose, Dose-Escalation Stage Followed by a Multidose, Parallel-Treatment Stage in Patients With Ulcerative Colitis | Ulcerative Colitis | Drug: placebo;Drug: rhuMAb Beta7 | Genentech, Inc. | Not recruiting | 18 Years | 70 Years | Both | 48 | Phase 1 | United States;Belgium;Canada;Germany;Netherlands;United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 651 | NCT00720538 | August 2008 | 19 February 2015 | Thalidomide in Pediatric Inflammatory Bowel Diseases. | Randomized Controlled Double-blind Vs. Placebo Multicentre Study on the Safety and Effectiveness of Thalidomide in the Treatment of Refractory Crohn's Disease and Ulcerative Colitis. | Inflammatory Bowel Diseases;Crohn's Disease;Ulcerative Colitis | Drug: Thalidomide;Drug: placebo | IRCCS Burlo Garofolo | Ospedale Meyer;Pediatric Gastroenterology Unit, IRCCS Gaslini, Genoa.;Vittore Buzzi Children's Hospital;University of Pisa;Pediatric Gastroenterology Unit, University of Messina.;Università degli Studi di Brescia;University of Trieste | Not recruiting | 2 Years | 18 Years | Both | 84 | Phase 3 | Italy |
| 652 | EUCTR2007-005166-12-DE | 29/07/2008 | 11 September 2012 | A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without Mesalamine | A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients with Mild to Moderate Active Ulcerative Colitis with or without Mesalamine | active mild to moderate ulcerative colitis defined as a Mayo clinical score of 4-10 points MedDRA version: 9.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis ;active mild to moderate ulcerative colitis defined as a Mayo clinical score of 4-10 points MedDRA version: 9.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis | Product Name: HMPL-004 Pharmaceutical Form: Capsule* Current Sponsor code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA (ethanol extract) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Pharmaceutical Form: Capsule* Current Sponsor code: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA (ethanol extract) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Hutchison MediPharma Enterprises Limited | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Germany | |||
| 653 | NCT00578799 | July 2008 | 19 February 2015 | Effects of Probiotics in Patients With Ulcerative Colitis | Effects of Probiotics in Patients With Ulcerative Colitis. | Ulcerative Colitis | Dietary Supplement: Kyo-Dophilus;Dietary Supplement: placebo | University of California, Irvine | Wakunaga Pharmaceutical Co., Ltd. | Not recruiting | 18 Years | 65 Years | Both | 40 | Phase 1 | United States |
| 654 | NCT00729872 | July 2008 | 19 February 2015 | A Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011 in Ulcerative Colitis | A Phase 2a Randomized, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects With Moderately Active Ulcerative Colitis | Moderately Active Ulcerative Colitis | Biological: AG011;Other: Placebo | ActoGeniX N.V. | Not recruiting | 18 Years | N/A | Both | 60 | Phase 1/Phase 2 | Belgium;Canada;Netherlands;Sweden | |
| 655 | EUCTR2007-007928-18-DE | 04/06/2008 | 20 May 2013 | Evaluation of efficacy and safety of the herbal drug Myrrhinil-Intest vs. mesalazine in maintaining clinical remission of ulcerative colitis - a 12-month, multicenter, randomized, prospective, double-blind, double-dummy, active-controlled and parallel group phase IV-trial - MIRCU | Evaluation of efficacy and safety of the herbal drug Myrrhinil-Intest vs. mesalazine in maintaining clinical remission of ulcerative colitis - a 12-month, multicenter, randomized, prospective, double-blind, double-dummy, active-controlled and parallel group phase IV-trial - MIRCU | ulcerative colitis patients in clinical remission MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Trade Name: Myrrhinil-Intest® Pharmaceutical Form: Coated tablet INN or Proposed INN: MATRICARIA FLOWER Other descriptive name: MATRICARIA FLOWER Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 70- INN or Proposed INN: MYRRH CAS Number: 9000457 Other descriptive name: MYRRH Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: COFFEE COAL CAS Number: 8000047907 Other descriptive name: COFFEE COAL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use Trade Name: Salofalk® 500mg Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: MESALAZINE CAS Number: 89576 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Pharmaceutical form of the placebo: Gastro-resistant tablet Route of administration of the placebo: Oral use | REPHA GmbH | Not Recruiting | Female: yes Male: yes | Phase 4 | Germany | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 656 | EUCTR2008-000045-59-FR | 04/06/2008 | 19 March 2012 | Multicentre, controlled, randomized, investigator-blinded, comparative study of oral Mesalazine 4g per day Once daily versus 4g per day in Two divided doses in patients with active Ulcerative colitiS - MOTUS | Multicentre, controlled, randomized, investigator-blinded, comparative study of oral Mesalazine 4g per day Once daily versus 4g per day in Two divided doses in patients with active Ulcerative colitiS - MOTUS | Patients with mild to moderate ulcerative colitis MedDRA version: 9.1 Level: LLT Classification code 10058816 Term: Colitis ulcerative acute episode | Product Name: Pentasa 2g sachet prolonged release granules (95%) Pharmaceutical Form: Granules INN or Proposed INN: MESALAZINE CAS Number: 89576 Concentration unit: g gram(s) Concentration type: equal Concentration number: 2- | Ferring SAS | Authorised | Female: yes Male: yes | 398 | United Kingdom;Netherlands;Belgium;France | ||||
| 657 | EUCTR2006-004776-12-SE | 02/06/2008 | 12 June 2012 | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Efficacy and safety of oral budesonide-MMX™ (CB-01-02) 6 mg and 9 mg extended release tablets in patients with mild or moderate active ulcerative colitis. A multicentre, randomised, double-blind, double-dummy, comparative study versus placebo with an additional reference arm evaluating entocort®EC | Mild or moderate active ulcerative colitis. MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Product Name: Budesonide-MMX™ Product Code: CB-01-02 Pharmaceutical Form: Tablet INN or Proposed INN: budesonide CAS Number: 51333-22-3 Other descriptive name: CB-01-02 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 6- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Entocort® CR Pharmaceutical Form: Capsule* INN or Proposed INN: budesonide CAS Number: 51333-22-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Product Name: Budesonide-MMX Product Code: CB-01-02 Pharmaceutical Form: Tablet INN or Proposed INN: budesonide CAS Number: 51333-22-3 Other descriptive name: CB-01-02 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 9- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | COSMO Technologies Ltd | Not Recruiting | Female: yes Male: yes | 492 | United Kingdom;Belgium;Estonia;France;Italy;Latvia;Lithuania;Sweden | ||||
| 658 | NCT00679380 | June 2008 | 19 October 2017 | (CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis | Efficacy and Safety of Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablets in Patients With Mild or Moderate Active Ulcerative Colitis. A Multicentre, Randomised, Double-Blind, Double-Dummy, Comparative Study Versus Placebo With an Additional Reference Arm Evaluating Entocort®EC | Ulcerative Colitis | Procedure: Blood sampling, endoscopy;Drug: Budesonide MMX® 6 mg;Drug: Budesonide MMX® 9 mg;Drug: Entocort EC® 3 mg;Drug: Placebo | Valeant Pharmaceuticals International, Inc. | Cosmo Technologies Ltd | Not recruiting | 18 Years | 75 Years | All | 514 | Phase 3 | Australia;Belgium;Estonia;France;Israel;Italy;Latvia;Lithuania;Poland;Romania;Russian Federation;Slovakia;Sweden;Ukraine;United Kingdom |
| 659 | NCT00679432 | June 2008 | 19 October 2017 | (CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis | Efficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol® 2400 mg. | Ulcerative Colitis | Procedure: Blood sampling, endoscopy;Drug: budesonide-MMX® 6 mg;Drug: budesonide-MMX® 9 mg;Drug: Placebo;Drug: Asacol® 400 mg | Valeant Pharmaceuticals International, Inc. | Not recruiting | 18 Years | 75 Years | All | 510 | Phase 3 | United States;Canada;India;Mexico | |
| 660 | NCT00616434 | May 2008 | 19 October 2017 | A Phase 2 Study of Interferon Beta-1a (Avonex®) in Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Avonex® in Subjects With Moderate to Severe Ulcerative Colitis | Active Ulcerative Colitis | Drug: BG9418 (Interferon beta-1a);Drug: Placebo | Biogen | Not recruiting | 18 Years | 65 Years | All | 123 | Phase 2 | United States;Canada;Czech Republic;Hungary;Poland;Russian Federation;Slovakia | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 661 | NCT00676832 | May 2008 | 19 February 2015 | Study of COLAL-PRED to Treat Moderate to Severe Ulcerative Colitis | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of COLAL-PRED in the Treatment of Patients With Moderate to Severe Ulcerative Colitis | Colitis, Ulcerative | Drug: Placebo;Drug: COLAL-PRED | Prometheus Laboratories | Not recruiting | 18 Years | 75 Years | Both | 190 | Phase 2 | United States | |
| 662 | EUCTR2008-001467-10-GB | 30/04/2008 | 24 July 2012 | Trial of Adjuvant Vitamin D with Standard Maintenance Therapy in Preventing Relapse of Inflammatory Bowel Disease - IBDVit3 | Ulcerative colitis - in remission Crohn's Disease - in remission MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease | Trade Name: Vigantol Oel Product Name: Vigantol Oel TM Pharmaceutical Form: Oral liquid Pharmaceutical form of the placebo: Oral liquid Route of administration of the placebo: Oral use | Imperial College London | Not Recruiting | Female: yes Male: yes | 120 | United Kingdom | |||||
| 663 | EUCTR2007-006692-37-GB | 10/04/2008 | 19 March 2012 | The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit | The Immunomodulatory Role of Vitamin D in Inflammatory Bowel Disease (IBDVit): IBDVit1 - Trial of Adjuvant Vitamin D with Corticosteroids in Active Crohn’s Disease; IBDVit2 - Trial of Adjuvant Vitamin D with Infliximab in Active Crohn's Disease; IBDVit3 - Trial of Adjuvant Vitamin D with standard maintenance therapy in preventing relapse of Inflammatory Bowel Disease. - IBDVit | IBDVit1 - Active Crohn's Disease IBDVit2 - Active Crohn's Disease IBDVit3 - Crohn's Disease in remission / Ulcerative Colitis in remission MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Trade Name: Vigantol Oel Product Name: Vigantol Oel TM Pharmaceutical Form: Oral liquid Pharmaceutical form of the placebo: Oral liquid Route of administration of the placebo: Oral use | Imperial College London | Authorised | Female: yes Male: yes | 210 | United Kingdom | ||||
| 664 | EUCTR2007-007702-30-IT | 03/04/2008 | 19 March 2012 | Feasibility and safety of Infliximab enema treatment in patients with active left-sided ulcerative colitis. An open-label, non comparative, pilot study. - ND | Feasibility and safety of Infliximab enema treatment in patients with active left-sided ulcerative colitis. An open-label, non comparative, pilot study. - ND | Ulcerative colitis MedDRA version: 9.1 Level: SOC Classification code 10017947 Term: Gastrointestinal disorders | Trade Name: REMICADE Pharmaceutical Form: Powder for infusion* INN or Proposed INN: INFLIXIMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | COSMO TECHNOLOGIES LTD | Not Recruiting | Female: no Male: yes | Italy | |||||
| 665 | NCT00656890 | April 2008 | 19 February 2015 | A Study of MDX-1100 in Subjects With Active Ulcerative Colitis | A Phase 2, Multi-dose, Double-blind, Placebo-controlled, Randomized, Multicenter Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Biological: sterile saline for injection;Biological: MDX-1100 | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | Both | 110 | Phase 2 | United States;Canada;Czech Republic;Hungary;Latvia;Romania;Russian Federation;Ukraine | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 666 | NCT00659802 | March 2008 | 19 February 2015 | Phase II Study of HMPL-004 in Patients With Ulcerative Colitis | A Phase II, Randomized, Multi-Centre, Double-Blind, Placebo-Controlled Trial of HMPL-004 in Patients With Mild to Moderate Active Ulcerative Colitis With or Without Mesalamine | Ulcerative Colitis | Drug: HMPL-004;Drug: Placebo | Hutchison Medipharma Limited | Not recruiting | 18 Years | N/A | Both | 224 | Phase 2 | United States | |
| 667 | NCT00718094 | March 2008 | 16 December 2017 | Pilot Study of Green Tea Extract (Polyphenon E®)in Ulcerative Colitis | A Phase IIa Pilot Study to Determine the Safety of an Oral Dose of Green Tea Extract (Polyphenon E®) and Provide Preliminary Evidence to Support Its Efficacy in Ulcerative Colitis | Mild to Moderately Active Ulcerative Colitis | Drug: Polyphenon E®;Drug: Placebo Oral Tablet | University of Louisville | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Not recruiting | 18 Years | 85 Years | All | 20 | Phase 2 | United States |
| 668 | NCT00628433 | February 2008 | 19 February 2015 | Safety and Pharmacokinetics Study of HE3286 in Patients With Active, Mild-to-Moderate Ulcerative Colitis | A Phase I/II, Double-Blind, Randomized, Placebo-Controlled, Dose Ranging Study of the Safety, Tolerance, Pharmacokinetics and Activity of HE3286 When Administered Orally to Patients With Active, Mild-to-Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: Placebo;Drug: HE3286 | Harbor Therapeutics | Not recruiting | 18 Years | 65 Years | Both | 27 | Phase 1/Phase 2 | United States | |
| 669 | NCT00621257 | January 2008 | 16 December 2017 | Vitamin D Levels in Children With IBD | Optimization of Vitamin D Stores and Its Impact on the Bone Health and Disease Outcomes of Children and Adolescents With IBD. | Inflammatory Bowel Disease;Crohn's Disease;Ulcerative Colitis | Dietary Supplement: ergocalciferol;Dietary Supplement: Cholecalciferol | Boston Children’s Hospital | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);Crohn's and Colitis Foundation;NASPGHAN Foundation | Not recruiting | 5 Years | 21 Years | All | 134 | N/A | United States |
| 670 | NCT01045018 | January 2008 | 19 February 2015 | A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis | BE Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400 mg to the Reference Listed Drug ASACOL® Delayed Release Tablets 400 mg in Patients With Mild to Moderately Active Ulcerative Colitis | Mild to Moderate Ulcerative Colitis | Drug: Placebo;Drug: Mesalamine | EMET Pharmaceuticals, LLC | Eagle Pharmaceuticals, Inc. | Not recruiting | 18 Years | N/A | Both | Phase 3 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 671 | EUCTR2006-004230-32-PL | 07/12/2007 | 19 March 2012 | EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE GASTRO-RESISTANT, PROLONGED RELEASE TABLETS (CHF 1514) COMPARED WITH ORAL PREDNISONE, IN A 8-WEEK TREATMENT PERIOD, IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS. AN INTERNATIONAL, MUTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP STUDY - Beta study | EFFICACY AND SAFETY OF BECLOMETHASONE DIPROPIONATE GASTRO-RESISTANT, PROLONGED RELEASE TABLETS (CHF 1514) COMPARED WITH ORAL PREDNISONE, IN A 8-WEEK TREATMENT PERIOD, IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS. AN INTERNATIONAL, MUTICENTRE, RANDOMISED, DOUBLE BLIND, PARALLEL GROUP STUDY - Beta study | Ulcerative Colitis extending proximally beyond the rectum with bleeding, verified by endoscopic examination MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Trade Name: Clipper Pharmaceutical Form: Modified-release tablet INN or Proposed INN: Beclomethasone diproprionate CAS Number: 5534-09-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Modified-release tablet Route of administration of the placebo: Oral use Trade Name: Deltacortene Pharmaceutical Form: Tablet INN or Proposed INN: Prednisone CAS Number: 53-03-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Trade Name: Deltacortene Pharmaceutical Form: Tablet INN or Proposed INN: Prednisone CAS Number: 53-03-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- | Chiesi Farmaceutici SpA | Authorised | Female: yes Male: yes | 300 | Belgium;Spain;Italy;Poland | ||||
| 672 | NCT00619489 | December 2007 | 19 October 2017 | Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease | Phase 2, Multiple Dose, Open-Label Study to Determine the Long Term Safety of MLN0002 in Patients With Ulcerative Colitis and Crohn's Disease | Ulcerative Colitis;Crohn's Disease | Drug: vedolizumab | Millennium Pharmaceuticals, Inc. | Not recruiting | 18 Years | 75 Years | All | 72 | Phase 2 | Canada | |
| 673 | EUCTR2007-002542-38-DK | 28/11/2007 | 3 April 2017 | A clinical study to explore the safe and effective use of the drug sotrastaurin in patients with ulcerative colitis | A randomized, double blind, placebo controlled, parallel group design study to explore the efficacy, safety and tolerability of AEB071 in patients with active, moderate to severe ulcerative colitis. - A2210 | Ulcerative colitis MedDRA version: 14.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Sotrastaurin Product Code: AEB071 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Sotrastaurin (INN) acetate CAS Number: 425637-18-9 Current Sponsor code: AEB071 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100 -mg Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: Vitamin B2 Pharmaceutical Form: Tablet INN or Proposed INN: Riboflavin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20-mg | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Denmark;Germany | |||
| 674 | EUCTR2007-003815-30-ES | 27/11/2007 | 2 September 2013 | Estudio abierto, randomizado, multicéntrico para comparar la eficacia y la seguridad de la prednisona y granulocitoféresis con Adacolumn® versus la prednisona sola en el tratamiento de pacientes con colitis ulcerosa activa corticodependiente leve a moderada. | Estudio abierto, randomizado, multicéntrico para comparar la eficacia y la seguridad de la prednisona y granulocitoféresis con Adacolumn® versus la prednisona sola en el tratamiento de pacientes con colitis ulcerosa activa corticodependiente leve a moderada. | Colitis ulcerosa corticodependiente leve o moderada MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Trade Name: DACORTIN Product Name: PREDNISONE Pharmaceutical Form: Tablet INN or Proposed INN: PREDNISONE CAS Number: N/A Current Sponsor code: N/A Other descriptive name: N/A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- | GETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa) | Not Recruiting | Female: yes Male: yes | Portugal;Spain | |||||
| 675 | NCT00573794 | November 2007 | 16 December 2017 | Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis | A Multicenter, Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Ulcerative Colitis | Ulcerative Colitis | Biological: adalimumab | AbbVie (prior sponsor, Abbott) | Not recruiting | 18 Years | 99 Years | All | 592 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Netherlands;New Zealand;Poland;Puerto Rico;Slovakia;Spain;Sweden;Switzerland;Czech Republic | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 676 | EUCTR2006-002670-22-DE | 31/10/2007 | 19 March 2012 | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1). Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-up of Efficacy and Safety (Part 2) - UC SUCCESS | Ulcerative Colitis MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Trade Name: Remicade Product Name: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: Infliximab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Powder for concentrate for solution for infusion Route of administration of the placebo: Intravenous use Trade Name: Imuran Product Name: Overencapsulated Azathioprine (Imuran) 50 mg Tablet Product Code: SCH 900050 Pharmaceutical Form: Capsule* INN or Proposed INN: azathioprine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Schering-Plough Research Institute, a division of Schering Corporation | Not Recruiting | Female: yes Male: yes | 600 | Portugal;Hungary;United Kingdom;Czech Republic;Germany;Belgium;France;Spain;Italy | ||||
| 677 | EUCTR2006-005377-22-DE | 23/10/2007 | 28 January 2013 | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC | Double-blind, double-dummy, randomised, multi-centre, comparative phase III clinical study on the efficacy and tolerability of an 8 week oral treatment with 9 mg budesonide or 3 g mesalazine in patients with active ulcerative colitis - Budesonide capsules versus mesalazine granules in active UC | Treatment of ulcerative colitis MedDRA version: 9.1 Level: LLT Classification code 10066678 Term: Acute ulcerative colitis | Trade Name: Budenofalk 3mg Pharmaceutical Form: Gastro-resistant capsule, hard INN or Proposed INN: BUDESONIDE CAS Number: 51333223 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3- Pharmaceutical form of the placebo: Gastro-resistant capsule, hard Route of administration of the placebo: Oral use Trade Name: Salofalk 1000mg Granu-Stix Pharmaceutical Form: Gastro-resistant granules INN or Proposed INN: MESALAZINE CAS Number: 89576 Concentration unit: g gram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Gastro-resistant granules Route of administration of the placebo: Oral use | Dr. Falk Pharma GmbH | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Czech Republic;Poland;Spain;Lithuania;Latvia;Germany | |||
| 678 | EUCTR2007-004732-23-EE | 22/10/2007 | 19 March 2012 | A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis | A Multicenter, Randomized, Partially Blinded, Placebo Controlled, Parallel Design, Three-Arm, Bioequivalence Study With Clinical Endpoints Comparing Mesalamine Delayed Release Tablets 400mg To The Reference Listed Drug Asacol Delayed Release Tablets 400mg In Patients With Mild To Moderately Active Ulcerative Colitis | Mild to moderately active ulcerative colitis MedDRA version: 9.1 Level: LLT Classification code 10009900 Term: Colitis ulcerative | Product Name: Mesalamine Delayed Release Tablets 400mg Pharmaceutical Form: Tablet INN or Proposed INN: MESALAZINE CAS Number: 89576 Current Sponsor code: QBC01 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Asacol Product Name: Asacol Delayed-Release Tablets Pharmaceutical Form: Tablet INN or Proposed INN: MESALAZINE CAS Number: 89576 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- | EMET Pharmaceuticals LLC | Not Recruiting | Female: yes Male: yes | 435 | Estonia;Latvia;Poland | ||||
| 679 | EUCTR2007-000842-11-AT | 15/10/2007 | 7 November 2016 | 99Tc labled Inliximab for evaluation of inflammatory activity in patients with inflammtory bowel disease (IBD) | 99Tc labled Inliximab for evaluation of inflammatory activity in patients with inflammtory bowel disease (IBD) | Inflammatory bowel disease Crohn´s disease Ulcerative colitis | Pharmaceutical Form: Intravenous infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277313 | Medical University of Graz | Not Recruiting | Female: yes Male: yes | Phase 2 | Austria | ||||
| 680 | NCT00603733 | October 2007 | 19 October 2017 | Canadian Active & Maintenance Modified Pentasa Study | A Multicentre, Randomised, Double-blind, Non-inferiority Trial Comparing the Efficacy and Safety of a New Modified Oral Extended Release Pentasa® (Mesalamine) 500 mg Tablet to the Currently Marketed Pentasa® (Mesalamine) 500 mg Tablet in Subjects With Active Mild to Moderate Ulcerative Colitis Treated With 4 g/Day for 8 Weeks and in Maintenance of Remission of Ulcerative Colitis in Subjects Treated With 2 g/Day for 24 Weeks | Active Ulcerative Colitis;Remission of Ulcerative Colitis | Drug: 5-ASA (5-Aminosalicylate) | Ferring Pharmaceuticals | Not recruiting | 18 Years | 75 Years | All | 288 | Phase 3 | Canada | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 681 | NCT00488631 | September 2007 | 19 October 2017 | An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Maintenance Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Biological: Placebo;Biological: Golimumab 50 mg;Biological: Golimumab 100 mg;Biological: Golimumab 200 mg | Janssen Research & Development, LLC | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | N/A | All | 1228 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;Hungary;India;Israel;Japan;Latvia;Lithuania;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Former Serbia and Montenegro;Nauru;United Kingdom |
| 682 | NCT00498589 | September 2007 | 19 February 2015 | Comparison of Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis | A Controlled, Randomized, Double-blind, Multicenter Study, Comparing Methotrexate vs Placebo in Corticosteroid-dependent Ulcerative Colitis | Ulcerative Colitis | Drug: methotrexate;Drug: placebo | Centre Hospitalier Universitaire de Besancon | Not recruiting | 18 Years | 75 Years | Both | 110 | Phase 2 | Austria;Belgium;France;Israel;Italy;Netherlands | |
| 683 | NCT00521950 | September 2007 | 19 February 2015 | Cost-effectiveness of TPMT Pharmacogenetics | Pharmacogenetic Testing in the Clinical Setting: is Screening for TPMT Genotype a Cost-effective Treatment Strategy? - The First Prospective Randomized Controlled Trial Within the Dutch Health Care System. | Inflammatory Bowel Diseases;Crohn Disease;Ulcerative Colitis | Genetic: TPMT genotyping; Drug: azathioprine or 6-mercaptopurine;Drug: azathioprine (AZA) or 6-mercaptopurine (6-MP) | ZonMw: The Netherlands Organisation for Health Research and Development | Radboud University | Not recruiting | 18 Years | N/A | Both | 853 | N/A | Netherlands |
| 684 | EUCTR2006-000410-20-DK | 13/08/2007 | 19 March 2012 | A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis | A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE®) in Pediatric Subjects with Moderately to Severely Active Ulcerative Colitis | Ulcerative colitis MedDRA version: 8.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Trade Name: Remicade Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: infliximab CAS Number: 170277-31-3 Current Sponsor code: CNTO 168 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | Centocor BV | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Netherlands;Belgium;Denmark;Italy | |||
| 685 | EUCTR2006-006052-35-IT | 08/08/2007 | 19 March 2012 | An open label study to determine the safety and tolerability of two dose escalation treatment regimens with an oral, delayed release preparation of nicotine in patients with stable ulcerative colitis maintained by steroid therapy. - ND | An open label study to determine the safety and tolerability of two dose escalation treatment regimens with an oral, delayed release preparation of nicotine in patients with stable ulcerative colitis maintained by steroid therapy. - ND | Ulcerative colitis MedDRA version: 9.1 Level: LLT Classification code 10009900 Term: Colitis ulcerative | Product Name: Nicolon Pharmaceutical Form: Modified-release capsule, hard CAS Number: 54-11-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 3- | S.L.A. PHARMA (UK) LTD | Not Recruiting | Female: yes Male: yes | Italy | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 686 | EUCTR2006-003604-19-DE | 06/08/2007 | 19 March 2012 | A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Ulcerative Colitis (UC) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy. Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, Date: 02-Nov-06). + Protocol amendment 04 (Biopsy substudy) - Site specific | A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Ulcerative Colitis (UC) who have had an Inadequate Clinical Response and/or Intolerance to Medical Therapy. Revised Protocol 03 incorporating Amendments 02 (v1.0, Date 06-Dec-2006), 03 (v1.0, Date 05-Mar-2007), 08 (v1.0, Date 22-Dec-2008) and Administrative Letters 01, 02 & 03. And Pharmacogenetics Blood Sample Amendment 01 - Site Specific (v2.0, Date: 02-Nov-06). + Protocol amendment 04 (Biopsy substudy) - Site specific | ULCERATIVE COLITIS,NOS MedDRA version: 8.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Abatacept CAS Number: 332348-12-6 Current Sponsor code: CTLA4Ig Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Bristol-Myers Squibb International Corporation | Not Recruiting | Female: yes Male: yes | 978 | Phase 3 | Czech Republic;United Kingdom;Germany;Belgium;France;Ireland;Italy;Poland | |||
| 687 | NCT00487539 | August 2007 | 19 October 2017 | An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Subcutaneously, in Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Biological: Placebo;Biological: Golimumab 100 mg;Biological: Golimumab 200 mg;Biological: Golimumab 400 mg;Biological: Golimumab 50 mg | Janssen Research & Development, LLC | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | N/A | All | 1065 | Phase 2/Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;Hungary;India;Israel;Japan;Lithuania;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Latvia;United Kingdom |
| 688 | NCT00488774 | August 2007 | 19 October 2017 | An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis | A Phase 2/3 Multicenter, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Golimumab Induction Therapy, Administered Intravenously, in Subjects With Moderately to Severely Active Ulcerative Colitis | Colitis, Ulcerative | Other: Placebo;Drug: Golimumab 1 mg per kg;Drug: Golimumab 2 mg per kg;Drug: Golimumab 4 mg per kg | Janssen Research & Development, LLC | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | N/A | All | 291 | Phase 2/Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;France;Germany;Hungary;India;Israel;Latvia;Lithuania;Netherlands;New Zealand;Poland;Romania;Russian Federation;Serbia;Slovakia;Sweden;Ukraine;Former Serbia and Montenegro;United Kingdom |
| 689 | NCT02093767 | August 2007 | 16 December 2017 | Oligofructose-enriched Inulin for the Treatment of Mild to Moderate Active Ulcerative Colitis | Open-Label Trial of a Prebiotic Preparation Containing Inulin and Oligofructose (Synergy-1) for the Treatment of Mild to Moderate Acute Ulcerative Colitis | Ulcerative Colitis | Dietary Supplement: Synergy1 | University of Alberta | Canadian Institutes of Health Research (CIHR);Crohn's and Colitis Canada;Beneo GmbH | Not recruiting | 18 Years | 65 Years | All | 24 | N/A | Canada |
| 690 | NCT00505778 | July 2007 | 19 October 2017 | A Comparison of Once a Day Dose Compared to 2 Doses/Day | A Multi-center, Investigator-blinded, Randomized, 12-month, Parallel-group, Non-inferiority Study to Compare the Efficacy of 1.6 to 2.4 g Asacol® Therapy QD Versus Divided Dose (BID) in the Maintenance of Remission of Ulcerative Colitis | Ulcerative Colitis | Drug: Mesalamine Once-Daily;Drug: Mesalamine Twice-Daily | Warner Chilcott | Not recruiting | 18 Years | N/A | All | 1027 | Phase 3 | United States;Canada;Puerto Rico | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 691 | NCT00537316 | July 2007 | 16 December 2017 | Efficacy & Safety of Infliximab Monotherapy Vs Combination Therapy Vs AZA Monotherapy in Ulcerative Colitis (Part 1) Maintenance Vs Intermittent Therapy for Maintaining Remission (Part 2)(Study P04807) | Comparison of the Efficacy and Safety of Infliximab, as Monotherapy or in Combination With Azathioprine, Versus Azathioprine Monotherapy in Moderate to Severe Active Ulcerative Colitis (Part 1) Comparison of Maintenance Versus Intermittent Infliximab Treatment in Maintaining Remission: A Follow-Up of Efficacy and Safety (Part 2) | Ulcerative Colitis | Biological: Infliximab (IFX);Drug: Azathioprine (AZA);Drug: Placebo to Azathioprine;Drug: Placebo infusion | Merck Sharp & Dohme Corp. | Not recruiting | 21 Years | N/A | All | 242 | Phase 3 | Argentina;Belgium;Canada;Colombia;Czech Republic;France;Germany;Hungary;Italy;Poland;Portugal;Russian Federation;Spain;Sweden;Switzerland;Ukraine;United Kingdom | |
| 692 | NCT01061996 | July 2007 | 19 February 2015 | Basiliximab Maintenance in Ulcerative Colitis | An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis | Ulcerative Colitis | Drug: Basiliximab | Cerimon Pharmaceuticals | Not recruiting | 18 Years | 75 Years | Both | 88 | Phase 2 | United Kingdom | |
| 693 | JPRN-UMIN000004401 | 2007/06/01 | 2 April 2019 | A Single Centre Prospective Randomized Double Blinded Trial to Assess the Efficiency of A Chinese Herbal-medicine (Xilei San) Suppository for Active Ulcerative Proctitis | Ulcerative colitis (Proctitis type) | Placebo arm: A sham suppository containing 0.1g of medical carbon during the study period (for 48 weeks). True arm: A suppository containing 0.1g of Herbal-medicine (Xilei San) during the study period | Hyogo College of Medicine, Department of Internal medicine, Division of Lower GI disease | Not Recruiting | 16years-old | 75years-old | Male and Female | 30 | Phase 2,3 | Japan | ||
| 694 | NCT00463151 | June 2007 | 19 February 2015 | An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis | An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis | Colitis, Ulcerative | Drug: rebamipide | Otsuka Pharmaceutical Co., Ltd. | Not recruiting | 16 Years | N/A | Both | 120 | Phase 2 | Japan | |
| 695 | NCT00542152 | June 2007 | 19 February 2015 | Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative Colitis | A Randomized, Multicenter Open Label Study Comparing Cyclosporine With Infliximab in Steroid-refractory Severe Attacks of Ulcerative Colitis | Ulcerative Colitis;Steroid Refractory | Drug: CYCLOSPORINE VS INFLIXIMAB | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Not recruiting | 18 Years | N/A | Both | 115 | Phase 4 | Belgium;Finland;France;Italy;Spain | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 696 | NCT00705484 | June 2007 | 16 December 2017 | European Safety Registry in Ulcerative Colitis (Study P04808AM3) | Ulcerative Colitis European Registry: A Prospective, Observational, Non-interventional, Post-Marketing Safety Surveillance Program | Ulcerative Colitis | Biological: infliximab;Drug: Standard Therapy | Merck Sharp & Dohme Corp. | Centocor, Inc. | Not recruiting | 18 Years | N/A | All | 2237 | Phase 4 | Austria;Belgium;Czech Republic;Denmark;France;Germany;Greece;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom;United States |
| 697 | NCT00606346 | May 31, 2007 | 11 November 2019 | A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease | A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease | Crohn's Disease;Ulcerative Colitis;Indeterminate Colitis;Inflammatory Bowel Diseases | Biological: Anti TNF therapy including infliximab;Drug: No Biologics | Janssen Biotech, Inc. | Not recruiting | 1 Month | 17 Years | All | 4970 | N/A | United States;Canada | |
| 698 | EUCTR2005-003707-37-BE | 25/05/2007 | 19 March 2012 | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC) MedDRA version: 9.0 Level: LLT Classification code 10045365 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 Pharmaceutical Form: Solution for injection INN or Proposed INN: Visilizumab CAS Number: 219716-33-3 Current Sponsor code: HuM291 Other descriptive name: anti-CD3 monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous bolus use (Noncurrent) | PDL BioPharma, Inc | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | Belgium;Austria | |||
| 699 | EUCTR2006-005299-42-FR | 16/05/2007 | 19 March 2012 | A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF | A randomized, multicenter open label study comparing cyclosporine with infliximab in steroid-refractory severe attacks of ulcerative colitis (CYSIF Study) - CYSIF | - Diagnosis of UC according to Lennard-Jones criteria - Endoscopically demonstrated colorectal lesions localized above the anal margin and extending at least up to 15cm proximally. - Severe acute flare of UC with a Lichtiger Index score > 10. - Refractoriness to high dose intravenous steroid therapy (= 0.8 mg/kg/d of methylprednisolone or equivalent) given for at least 5 days. MedDRA version: 9.1 Level: LLT Classification code 10045282 Term: UC | Trade Name: REMICADE Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277313 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: CICLOSPORIN CAS Number: 554 579 6 Other descriptive name: SANDINUM Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50-250 INN or Proposed INN: CICLOSPORIN CAS Number: 59865133 Other descriptive name: NEORAL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10/25/50/100 MG- Trade Name: CYCLOSPORIN Pharmaceutical Form: Concentrate for solution for infusion Trade Name: CYCLOSPORIN Pharmaceutical Form: Capsule* | GETAID | Authorised | Female: yes Male: yes | 100 | Finland;Belgium;France;Spain | ||||
| 700 | NCT00446849 | May 2007 | 19 October 2017 | Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC) | A Phase IV, Multi-center, Open-label Study to Assess Clinical Recurrence Related to Compliance With Treatment With MMX Mesalamine 2.4g/Day Given Once Daily for the Maintenance of Quiescent Ulcerative Colitis (UC) | Ulcerative Colitis | Drug: MMX Mesalamine | Shire | Not recruiting | 18 Years | N/A | All | 290 | Phase 4 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 701 | NCT00467922 | May 2007 | 19 February 2015 | An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy | A Randomized Prospective Double Blind Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care Versus Either Colloid and Crystalloid | Crohn's Disease;Ulcerative Colitis;Rectal Cancer;Colon Cancer;Colon Polyps;Rectal Polyps;Diverticulitis | Drug: Hextend;Drug: Lactated Ringers | Spectrum Health Hospitals | Deltex Medical, Inc. | Not recruiting | 18 Years | 80 Years | Both | 69 | Phase 3 | United States |
| 702 | NCT01177228 | May 2007 | 19 October 2017 | Study of Vedolizumab Following Multiple Intravenous Doses in Patients With Ulcerative Colitis | A Phase 2, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN0002 Following Multiple Intravenous Doses in Patients With Ulcerative Colitis | Ulcerative Colitis | Drug: Vedolizumab;Drug: Placebo | Millennium Pharmaceuticals, Inc. | Not recruiting | 18 Years | 70 Years | All | 47 | Phase 2 | ||
| 703 | EUCTR2006-004303-19-GB | 25/04/2007 | 21 August 2017 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, with Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis - BSX-001 | Steroid-refractory ulcerative colitis MedDRA version: 8.1 Level: LLT Classification code 10009900 Term: Colitis ulcerative | Trade Name: Simulect Pharmaceutical Form: Powder for infusion* Other descriptive name: Basiliximab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Powder for infusion* Route of administration of the placebo: Intravenous use | Cerimon Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 135 | Phase 2 | Czech Republic;Slovakia;Belgium;United Kingdom | |||
| 704 | EUCTR2006-006319-54-GB | 25/04/2007 | 19 March 2012 | An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002 | An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002 | Steroid-refractory ulcerative colitis MedDRA version: 8.1 Level: LLT Classification code 10009900 Term: Colitis ulcerative | Trade Name: Simulect Product Name: Basiliximab Pharmaceutical Form: Powder for infusion* Other descriptive name: Basiliximab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- | Cerimon Pharmaceuticals, Inc. | Authorised | Female: yes Male: yes | 135 | United Kingdom;Belgium | ||||
| 705 | NCT00403923 | April 2007 | 19 February 2015 | Amount of Lactose Causing Symptoms in People With Lactose Intolerance and Ulcerative Colitis | A Study to Determine the Threshold of Lactose Ingestion That Provokes Symptoms in Lactose Intolerant People Who Also Have Ulcerative Colitis | Lactose Intolerance;Ulcerative Colitis | Dietary Supplement: Lactose in water | University Hospitals, Leicester | Not recruiting | 18 Years | N/A | Both | 48 | Phase 0 | United Kingdom | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 706 | JPRN-UMIN000013925 | 2007/03/01 | 16 July 2019 | The efficacy of treatmenst with both Ganciclovir and GMAA for patients with ulcerative colitis concomitant cytomegalovirus infection | The efficacy of treatmenst with both Ganciclovir and GMAA for patients with ulcerative colitis concomitant cytomegalovirus infection - KIBDG-Protocol 1 | Ulcerative colitis | A Group: Ganciclovir monotherapy B Group: Ganciclovir and GMAA combination therapy C Group: GMAA monotherapy | Graduate School of Medicine, Kyoto University, Gastroenterology and Hepatology | Recruiting | 15years-old | 80years-old | Male and Female | 90 | Not applicable | Japan | |
| 707 | EUCTR2006-004162-13-DE | 27/02/2007 | 19 March 2012 | Randomized, double-blind, placebo-controlled phase II pilot study of the impact of mesalazine enemas on the mucosal gut flora in patients with inflammatory bowel disease - Impact of mesalazine vs placebo on mucosal gut flora in IBD patients | Randomized, double-blind, placebo-controlled phase II pilot study of the impact of mesalazine enemas on the mucosal gut flora in patients with inflammatory bowel disease - Impact of mesalazine vs placebo on mucosal gut flora in IBD patients | Active inflammatory bowel disease, i.e. either left-sided ulcerative colitis or Crohn´s Disease (Colon) with signs of inflammation within 40 cm ab ano. MedDRA version: 8.1 Level: LLT Classification code 10021972 Term: Inflammatory bowel disease | Trade Name: Salofalk 4g/60ml Klysma Pharmaceutical Form: Enema* INN or Proposed INN: MESALAZINE CAS Number: 89576 Current Sponsor code: Salofalk 4g/60ml Klysma Concentration unit: g/ml gram(s)/millilitre Concentration type: equal Concentration number: 0,666666- Pharmaceutical form of the placebo: Enema* Route of administration of the placebo: Rectal use | Charité Universitätsmedizin, Campus Charité Mitte | Authorised | Female: yes Male: yes | 40 | Phase 2 | Germany | |||
| 708 | NCT00430898 | January 2007 | 19 February 2015 | Basiliximab in Moderate to Severe Ulcerative Colitis | A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, With Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis | Ulcerative Colitis | Drug: Basiliximab | Cerimon Pharmaceuticals | Not recruiting | 18 Years | 75 Years | Both | 181 | Phase 2 | United States;Belgium;Czech Republic;India;Poland;Russian Federation;Slovakia;Ukraine;United Kingdom | |
| 709 | NCT00502294 | January 2007 | 19 February 2015 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous Steroid-Refractory Ulcerative Colitis | Drug: Visilizumab (HuM291; Nuvion®) | Facet Biotech | PDL BioPharma, Inc. | Not recruiting | 18 Years | N/A | Both | 150 | Phase 3 | |
| 710 | EUCTR2007-005702-49-PL | 2 October 2017 | A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis. - CAMP II | A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8 g/day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents with Mildly-to-Moderately Active Ulcerative Colitis. - CAMP II | Mildly-to-Moderately Active Ulcerative Colitis in Children and Adolescents MedDRA version: 11.0 Level: LLT Classification code 10045365 Term: | Trade Name: Asacol Product Name: Asacol Product Code: NA Pharmaceutical Form: Film-coated tablet INN or Proposed INN: MESALAZINE CAS Number: 89576 Concentration unit: g gram(s) Concentration type: equal Concentration number: 0.4- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Procter & Gamble Pharmaceuticals | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Poland | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 711 | EUCTR2006-001782-42-HU | 20/12/2006 | 19 March 2012 | Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. | Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin (CB-01-05-MMX), administered as add-on therapy to oral mesalazine or other 5-ASA derivatives, in patients with active, left-sided, mild to moderate ulcerative colitis. A multicentre randomized, double-blind, comparative study versus placebo. | Active left-sided, mild to moderate ulcerative colitis MedDRA version: 8.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Product Name: CB-01-05-MMX Product Code: CB-01-05-MMX Pharmaceutical Form: Film-coated tablet CAS Number: 9041-08-1 Other descriptive name: PARNAPARIN SODIUM Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 210- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Cosmo Technologies Ltd | Not Recruiting | Female: yes Male: yes | 120 | Hungary;United Kingdom;Italy | ||||
| 712 | EUCTR2006-001846-15-SE | 06/12/2006 | 19 March 2012 | A placebo-controlled, randomised, double-blind, single dose proof of concept study of Kappaproct, in steroid resistant or steroid dependent patients with ulcerative colitis of mild to moderate degree | A placebo-controlled, randomised, double-blind, single dose proof of concept study of Kappaproct, in steroid resistant or steroid dependent patients with ulcerative colitis of mild to moderate degree | Active ulcerative colitis in steroid refractory or steroid dependent patients | Product Name: Kappaproct Product Code: DIMS0150 Pharmaceutical Form: Rectal solution Pharmaceutical form of the placebo: Rectal solution Route of administration of the placebo: Rectal use | InDex Pharmaceuticals AB | Not Recruiting | Female: yes Male: yes | 48 | Sweden | ||||
| 713 | NCT00410410 | December 2006 | 19 October 2017 | A Study of Abatacept in Patients With Active Ulcerative Colitis | A Phase 3, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With Abatacept in Subjects With Active Ulcerative Colitis (UC) Who Have Had an Inadequate Clinical Response and/or Intolerance to Medical Therapy | Ulcerative Colitis | Drug: abatacept (ABA);Drug: placebo;Drug: abatacept | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | All | 591 | Phase 3 | United States;Australia;Belgium;Brazil;Canada;Czech Republic;France;Germany;India;Ireland;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Puerto Rico;South Africa;Switzerland;United Kingdom;Argentina;Spain | |
| 714 | EUCTR2006-002036-25-GB | 09/11/2006 | 20 March 2012 | Epidermal growth factor enemas versus mesalazine enemas for the treatment of mild-to-moderate active left-sided ulcerative colitis or proctitis - EGF enema in UC | Epidermal growth factor enemas versus mesalazine enemas for the treatment of mild-to-moderate active left-sided ulcerative colitis or proctitis - EGF enema in UC | Ulcerative Colitis | Product Name: Epidermal growth factor enema Product Code: EGF enema Pharmaceutical Form: Enema INN or Proposed INN: Epidermal growth factor Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 5- Trade Name: Pentasa enema Product Name: Pentasa Pharmaceutical Form: Enema INN or Proposed INN: mesalazine enema Concentration unit: g gram(s) Concentration type: equal Concentration number: 1- | University Hospitals of Leicester NHS Trust | Authorised | Female: yes Male: yes | 50 | United Kingdom | ||||
| 715 | NCT00385736 | November 2006 | 19 October 2017 | Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative Colitis | A Multicenter, Randomized, Double-blind Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Biological: adalimumab;Biological: placebo | Abbott | Not recruiting | 18 Years | N/A | All | 576 | Phase 3 | United States;Austria;Belgium;Canada;Czech Republic;Germany;Hungary;Italy;Netherlands;Poland;Puerto Rico;Slovakia;Sweden | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 716 | NCT00408629 | November 2006 | 19 October 2017 | Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis | A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Biological: adalimumab;Biological: placebo | Abbott | Not recruiting | 18 Years | N/A | All | 518 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Czech Republic;Denmark;France;Germany;Hungary;Israel;New Zealand;Norway;Poland;Portugal;Spain;Switzerland;Sweden | |
| 717 | ChiCTR-TRC-08000048 | 2006-10-01 | 18 April 2017 | A multicenter, double-blind, randomized controlled trial: Traditional Chinese Medicine treatment for ulcerative colitis | Intervention and efficacy evaluation study of Traditional Chinese Medicine for ulcerative colitis | Ulcerative colitis | Controlled group:Take mesalazine 1g Qid in active stage. Sustain the treatment for another week after the symptoms relieve. Then take 0.5g Tid and adjust the dosage according to the condition. The treatment lasts for 6 months.;Experimental group:Take the intestine-clearing and dissipating dampness formula 2 times a day in the 1st stage. Enema is given once a day for 12 days. Take health-supporting and intestine-clearing formula for spleen and stomach deficiency 2 times a day. The treatment lasts for 6 months; | The Affiliated Hospital of Nanjing University of Traditional Chinese Medicine | Not Recruiting | 18 | 65 | Both | Controlled group:112;Experimental group:112; | Phase 1 study | China | |
| 718 | NCT00421642 | October 2006 | 19 February 2015 | Open-Label Adalimumab for Ulcerative Colitis Patients | An Open-Label Study of the Human Anti-TNF Monoclonal Antibody Adalimumab in Ulcerative Colitis Patients | Ulcerative Colitis | Drug: Adalimumab | Mayo Clinic | Not recruiting | 18 Years | N/A | Both | 20 | Phase 1 | United States | |
| 719 | NCT00486031 | October 2006 | 26 August 2019 | Open-Label, Long-term Balsalziade Disodium Tablet Ulcerative Colitis Study | A Multicenter, Open-label Trials to Evaluate the Long-term Safety and Tolerability of a New Balsalazide Disodium Tablet Formulation in Patients With Ulcerative Colitis | Inflammatory Bowel Disease;Ulcerative Colitis | Drug: Balsalazide Disodium | Bausch Health Americas, Inc. | Not recruiting | 18 Years | N/A | All | 443 | Phase 3 | United States | |
| 720 | NCT00951548 | October 2006 | 19 February 2015 | Food Supplementation With VSL#3 as a Support to Standard Pharmaceutical Therapy in Ulcerative Colitis | Food Supplementation With the Probiotic Preparation VSL#3 as a Support to Standard Pharmaceutical Therapy in Patients With Mild to Moderate Active Ulcerative Colitis. A Double-blind, Randomized, Placebo Controlled Study | Ulcerative Colitis | Dietary Supplement: VSL#3;Dietary Supplement: Placebo | VSL Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 144 | N/A | Italy | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 721 | NCT00336492 | September 2006 | 19 October 2017 | A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis | A Phase 3, Randomized, Open-label, Parallel-group, Multicenter Trial to Evaluate the Safety and Efficacy of Infliximab (REMICADE?) in Pediatric Subjects With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Biological: infliximab | Centocor, Inc. | Not recruiting | 6 Years | 17 Years | All | 60 | Phase 3 | United States;Belgium;Canada;Denmark;Netherlands | |
| 722 | NCT00343850 | September 2006 | 19 February 2015 | Once Daily Versus Conventional Dosing of Asacol in the Maintenance of Quiescent Ulcerative Colitis | Once Daily Versus Conventional Dosing of Asacol in the Maintenance of Quiescent Ulcerative Colitis: A Randomized Pilot Trial | Ulcerative Colitis | Drug: Asacol (mesalamine) | University of Chicago | Procter and Gamble | Not recruiting | 18 Years | N/A | Both | 30 | Phase 3 | United States |
| 723 | NCT00347048 | September 2006 | 19 February 2015 | Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients | Tacrolimus (FK506) P-III Placebo-Controlled Double-Blind Study in Moderate to Severe Refractory Ulcerative Colitis Patients | Ulcerative Colitis | Drug: tacrolimus;Drug: Placebo | Astellas Pharma Inc | Not recruiting | 16 Years | 64 Years | Both | 62 | Phase 3 | Japan | |
| 724 | NCT00355901 | September 2006 | 19 February 2015 | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis | Ulcerative Colitis | Drug: Visilizumab (Nuvion®; HuM291) | PDL BioPharma, Inc. | Not recruiting | 18 Years | N/A | Both | 300 | Phase 2 | United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Ireland;Italy;Netherlands;Norway;Ukraine | |
| 725 | NCT00643071 | September 2006 | 19 February 2015 | Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients | Tacrolimus (FK506) P-III, Open-label Study in Severe Refractory Ulcerative Colitis Patients or Patients Who Attended and Received Placebo in F506-CL-1107 Study | Ulcerative Colitis | Drug: Tacrolimus | Astellas Pharma Inc | Not recruiting | 16 Years | 64 Years | Both | 32 | Phase 3 | Japan | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 726 | NCT00279435 | August 2006 | 19 February 2015 | Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study | A Randomized, Double-blind, Multicenter Study of Visilizumab Versus Placebo in Subjects With Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study | Ulcerative Colitis | Drug: visilizumab | Facet Biotech | PDL BioPharma, Inc. | Not recruiting | 18 Years | N/A | Both | 25 | Phase 2/Phase 3 | United States;Australia;Austria;Belgium;Canada;Croatia;Czech Republic;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Ukraine |
| 727 | EUCTR2005-005363-28-GB | 11/07/2006 | 19 March 2012 | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS | The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum. | Trade Name: Kremezin Product Name: AST-120 Product Code: AST-120 Pharmaceutical Form: Granules INN or Proposed INN: AST-120 Current Sponsor code: AST-120 Other descriptive name: Kremezin®, Spherical Adsorptive Carbon Concentration unit: g gram(s) Concentration type: equal Concentration number: 2- Pharmaceutical form of the placebo: Granules Route of administration of the placebo: Oral use | Ocera Therapeutics, Inc. | Authorised | Female: yes Male: yes | 240 | Hungary;Germany;Czech Republic;United Kingdom;Belgium;Austria | ||||
| 728 | NCT00349388 | July 2006 | 19 October 2017 | Safety and Compliance of Taking Mesalamine Once a Day in Pediatric Patients | A Randomized Trial Comparing Once Daily Dosing vs. Multiple Doses a Day of Mesalamine in Pediatric Patients With Quiescent Ulcerative Colitis | Ulcerative Colitis | Drug: Asacol | Annette Langseder | Procter and Gamble | Not recruiting | 6 Years | 18 Years | All | 1 | N/A | United States |
| 729 | NCT00355602 | July 2006 | 19 February 2015 | Antibiotics for the Treatment of Ulcerative Colitis | Use of Antibiotics to Eradicate Bacterial Pathogens Colonising the Colonic Mucosa in Ulcerative Colitis Patients | Colitis, Ulcerative | Drug: Cefuroxime;Drug: Ciprofloxacin;Drug: Clarithromycin;Drug: Cotrimoxazole;Drug: Coamoxiclav;Drug: metronidazole;Drug: neomycin;Drug: rifaximin;Drug: Vancomycin;Drug: Doxycycline | University of Dundee | Tenovus Scotland | Not recruiting | 18 Years | 79 Years | Both | 40 | N/A | United Kingdom |
| 730 | EUCTR2005-004105-28-IE | 20/06/2006 | 19 March 2012 | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis. | An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis. | Intravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC). MedDRA version: 8.0 Level: LLT Classification code 10045265 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 Pharmaceutical Form: Solution for injection INN or Proposed INN: Visilizumab CAS Number: 219716-33-3 Current Sponsor code: HuM291 Other descriptive name: anti CD3 monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous bolus use (Noncurrent) | PDL BioPharma, Inc. | Authorised | Female: yes Male: yes | 300 | Hungary;Germany;United Kingdom;Netherlands;France;Ireland;Greece | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 731 | EUCTR2006-001310-32-EE | 16/06/2006 | 19 March 2012 | A double-blind, randomized, 6-week, parallel-group clinical trial to assess the safety and efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg mesalamine tablet) for the treatment of moderately active ulcerative colitis (ASCEND III) - ASCEND III | A double-blind, randomized, 6-week, parallel-group clinical trial to assess the safety and efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg mesalamine tablet) for the treatment of moderately active ulcerative colitis (ASCEND III) - ASCEND III | Ulcerative Colitis MedDRA version: 8.1 Classification code 10009900 | Product Name: Asacol 800 mg tablet Pharmaceutical Form: Modified-release tablet INN or Proposed INN: mesalazine Current Sponsor code: mesalamine (USAN) Other descriptive name: 5-aminosalicylic acid (5-ASA) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 800- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: Asacol 400 mg tablet Pharmaceutical Form: Modified-release tablet INN or Proposed INN: mesalazine Current Sponsor code: mesalamine (USAN) Other descriptive name: 5-aminosalicylic acid (5-ASA) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Procter & Gamble Technical Centres Limited | Not Recruiting | Female: yes Male: yes | 770 | Hungary;Czech Republic;Estonia;Latvia;Lithuania | ||||
| 732 | NCT00350415 | June 2006 | 19 February 2015 | A Double Blind Study for the Treatment of Acute Ulcerative Colitis | A Double-blind, Randomized, 6-week, Parallel-group Design Clinical Trial to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day for the Treatment of Moderately Active Ulcerative Colitis. | Ulcerative Colitis | Drug: Mesalamine | Warner Chilcott | Not recruiting | 18 Years | 75 Years | Both | 772 | Phase 3 | United States;Belarus;Canada;Croatia;Czech Republic;Estonia;Hungary;Latvia;Lithuania;Poland;Puerto Rico;Romania;Russian Federation;Serbia;Ukraine;Former Serbia and Montenegro | |
| 733 | EUCTR2006-000197-69-CZ | 30/05/2006 | 10 July 2015 | A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Calf Intestinal Alkaline Phosphatase in patients with moderate to severe ulcerative colitis | A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Calf Intestinal Alkaline Phosphatase in patients with moderate to severe ulcerative colitis | Inflammatory Bowel Disease | Product Name: Bovine-Calf Alkaline Phosphatase (BIAP) Pharmaceutical Form: Concentrate for solution for infusion | AM-Pharma B.V. | Authorised | Female: yes Male: yes | 24 | Czech Republic;Italy | ||||
| 734 | NCT00317356 | May 2006 | 19 February 2015 | A Dose-Finding Study of OPC-6535 in Patients With Active Ulcerative Colitis | A Dose-Finding Study of OPC-6535 in Patients With Active Ulcerative Colitis | Colitis, Ulcerative | Drug: OPC-6535(Tetomilast) | Otsuka Pharmaceutical Co., Ltd. | Not recruiting | 18 Years | 65 Years | Both | 160 | Phase 2 | Japan | |
| 735 | NCT00408174 | May 2006 | 19 February 2015 | Balsalazide Disodium vs. Mesalamine in Mildly to Moderately Active Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Actively-Controlled Trial to Evaluate the Safety and Efficacy of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium 3.3 g Bid Versus Mesalamine (5-ASA) as Asacol® 0.8 g Tid in Mildly to Moderately Active Ulcerative Colitis | Inflammatory Bowel Disease;Ulcerative Colitis | Drug: Balsalazide disodium | Salix Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 400 | Phase 3 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 736 | NCT00727324 | May 2006 | 19 February 2015 | Safety/Efficacy Study of Bovine Intestinal Alkaline Phosphatase in Patients With Moderate to Severe Ulcerative Colitis | A Pilot, Open-label, Multi-center Clinical Trial to Investigate the Safety and Efficacy of Bovine-Calf Intestinal Alkaline Phosphatase in Patients With Moderate to Severe Ulcerative Colitis. | Ulcerative Colitis | Drug: bovine intestinal alkaline phosphatase (BIAP) | AM-Pharma | CRM Biometrics GmbH;Sintesi Research Srl;Vigilex BV | Not recruiting | 18 Years | N/A | Both | 22 | Phase 2 | Czech Republic;Italy |
| 737 | NCT01026857 | May 2006 | 16 December 2017 | Propionyl-L-Carnitine in Ulcerative Colitis | Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomised, Multicenter Study to Investigate the Efficacy of Two Dosages of Propionyl-L-Carnitine Colon Release Tablets in Patients Affected by Ulcerative Colitis Under Oral Stable Treatment | Ulcerative Colitis | Drug: Propionyl-L-Carnitine;Drug: Placebo | sigma-tau i.f.r. S.p.A. | Not recruiting | 18 Years | 75 Years | All | 121 | Phase 2 | Italy;Lithuania;Poland;Russian Federation | |
| 738 | EUCTR2005-003481-42-SK | 21/04/2006 | 23 January 2017 | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study | A Randomized, Double-blind, Multicenter Study of Visilizumab versus Placebo in Subjects with Intravenous Steroid-refractory Ulcerative Colitis Previously Responsive in a Visilizumab Study | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 Pharmaceutical Form: Solution for injection INN or Proposed INN: Visilizumab CAS Number: 219716-33-3 Current Sponsor code: HuM291 Other descriptive name: anti-CD3 monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous bolus use (Noncurrent) | Protein Design Labs, Inc | Authorised | Female: yes Male: yes | 80 | Phase 2 | Czech Republic;Hungary;Slovakia;Greece;Spain;Ireland;Austria;Germany | |||
| 739 | EUCTR2006-000197-69-IT | 16/03/2006 | 19 March 2012 | A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Calf Intestinal Alkaline Phosphatase in patients with moderate to severe ulcerative colitis - AP IBD 02-02 | A pilot, open-label, multi-center clinical trial to investigate the safety and efficacy of Bovine-Calf Intestinal Alkaline Phosphatase in patients with moderate to severe ulcerative colitis - AP IBD 02-02 | Inflammatory Blowel Disease MedDRA version: 6.1 Level: PT Classification code 10009900 | Product Name: Bovine-Calf Alkaline Phosphatase BIAP Product Code: BIAP Pharmaceutical Form: Oral solution CAS Number: 9001-78-9 Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 14500- | AM PHARMA B.V. | Not Recruiting | Female: yes Male: yes | 24 | Italy | ||||
| 740 | EUCTR2005-005414-20-IT | 06/03/2006 | 19 March 2012 | Randomized controlled double-blind Vs. placebo multicentre study on the safety and effectiveness of thalidomide in the treatment of refractory Crohn s disease and ulcerative colitis. - Thalidomide and IBD | Randomized controlled double-blind Vs. placebo multicentre study on the safety and effectiveness of thalidomide in the treatment of refractory Crohn s disease and ulcerative colitis. - Thalidomide and IBD | Inflammatory Bowel Disease Crohn Disease, Ulcerative Colitis MedDRA version: 6.1 Level: PT Classification code 10021972 | Trade Name: Thalidomide Pharmion Pharmaceutical Form: Capsule, hard INN or Proposed INN: Thalidomide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | ISTITUTO PER L INFANZIA BURLO GAROFOLO | Authorised | Female: yes Male: yes | 124 | Italy | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 741 | EUCTR2005-003482-17-IE | 03/03/2006 | 19 March 2012 | A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2, Randomized, Double-blind, Multicenter, Dose-Exploration Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) MedDRA version: 8.0 Level: LLT Classification code 10045265 | Product Name: Visilizumab (Nuvion) Product Code: HuM291 Pharmaceutical Form: Solution for injection INN or Proposed INN: Visilizumab CAS Number: 219716-33-3 Current Sponsor code: HuM291 Other descriptive name: anti-CD3 monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1.0- | PDL BioPharma, Inc. | Authorised | Female: yes Male: yes | 100 | Phase 2 | United Kingdom;Spain;Ireland;Italy;Greece | |||
| 742 | NCT00299013 | March 2006 | 19 February 2015 | Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis | A Multicentre, Randomised, Double Blind, Double Dummy, Active Comparator Controlled, Parallel Group Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis | Ulcerative Colitis | Drug: COLAL-PRED®;Drug: Prednisolone | Alizyme | Not recruiting | 18 Years | 75 Years | Both | 796 | Phase 3 | Australia;Belgium;Czech Republic;Denmark;France;Germany;Hungary;Israel;Italy;Poland;Russian Federation;South Africa;Spain;Sweden;United Kingdom | |
| 743 | EUCTR2005-002784-91-GB | 06/02/2006 | 18 April 2012 | A Randomized, Multicentre, Parallel Group Single-Blind Study to Assess the Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily versus Divided Doses Three Times Daily for 12 Months in the Maintenance of Remission of Ulcerative Colitis. - CODA study (Colitis Once Daily Asacol) | A Randomized, Multicentre, Parallel Group Single-Blind Study to Assess the Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily versus Divided Doses Three Times Daily for 12 Months in the Maintenance of Remission of Ulcerative Colitis. - CODA study (Colitis Once Daily Asacol) | Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain. | Product Name: mesalazine Pharmaceutical Form: Tablet INN or Proposed INN: Mesalazine CAS Number: 89-57-6 Other descriptive name: 5-Aminosalicylic Acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 800- | Cardiff and Vale NHS Trust | Authorised | Female: yes Male: yes | 630 | United Kingdom | ||||
| 744 | NCT00279422 | February 2006 | 19 February 2015 | A Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis | Ulcerative Colitis | Drug: visilizumab | Facet Biotech | PDL BioPharma, Inc. | Not recruiting | 18 Years | N/A | Both | 127 | Phase 2/Phase 3 | United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Israel;Netherlands;Norway;Slovakia;Ukraine |
| 745 | NCT00296556 | February 2006 | 19 February 2015 | Therapeutic Study of ONO-4819CD for Ulcerative Colitis | A Randomized, Placebo-Controlled Trial of ONO-4819CD for Treatment of Mild to Moderate Ulcerative Colitis. | Ulcerative Colitis | Drug: Rivenprost (drug) | Kyoto University, Graduate School of Medicine | National Institute of Biomedical Innovation | Not recruiting | 20 Years | N/A | Both | 7 | Phase 2 | Japan |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 746 | NCT00295282 | January 2006 | 19 February 2015 | A Dose-Escalation Study of MDX-1100 in Patients With Active Ulcerative Colitis | A Phase I, Multicenter, Dose-escalation Study of MDX-1100 (Anti-CXCL10 Human Monoclonal Antibody) in Patients With Active Ulcerative Colitis | Ulcerative Colitis | Drug: MDX-1100 (anti-CXCL10 human monoclonal antibody) | Bristol-Myers Squibb | Not recruiting | 18 Years | N/A | Both | 24 | Phase 1 | United States | |
| 747 | EUCTR2005-002063-87-AT | 28/12/2005 | 20 May 2013 | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | A Phase 2/3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Visilizumab in Subjects with Intravenous Steroid-Refractory Ulcerative Colitis | Intravenous steroid-refractory ulcerative colitis (IVSR-UC) | Product Name: Visilizumab (Nuvion) Product Code: HuM291 Pharmaceutical Form: Solution for injection INN or Proposed INN: visilizumab CAS Number: 219716-33-3 Current Sponsor code: HuM291 Other descriptive name: anti-CD3 monoclonal antibody Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intravenous bolus use (Noncurrent) | Protein Design Labs, Inc. | Not Recruiting | Female: yes Male: yes | 150 | Phase 2/3 | Hungary;Czech Republic;Belgium;Austria;Germany | |||
| 748 | EUCTR2005-003471-20-IT | 07/12/2005 | 7 January 2013 | Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter Study to investigate the efficacy of Two Dosages of Propionyl-L-carnitine (ST 261) Colon Release Tablets in Patients Affected by Ulcerative Colitis under Oral Stable Treatment | Phase II, Parallel-group, Placebo Controlled, Double-blind, Randomized, Multicenter Study to investigate the efficacy of Two Dosages of Propionyl-L-carnitine (ST 261) Colon Release Tablets in Patients Affected by Ulcerative Colitis under Oral Stable Treatment | ULCERATIVE COLITIS MedDRA version: 14.1 Level: PT Classification code 10009900 Term: Colitis ulcerative System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Propionyl-L-carnitine Product Code: ST261 Pharmaceutical Form: Modified-release tablet INN or Proposed INN: Levocarnitine CAS Number: 119793-66-3 Concentration unit: % percent Concentration number: .5- | SIGMA-TAU | Not Recruiting | Female: yes Male: yes | Phase 2 | Lithuania;Italy | ||||
| 749 | JPRN-C000000288 | 2005/12/01 | 2 April 2019 | Z-206 Phase III Clinical Trial - Investigation on the remission-inducing effect in patients with ulcerative colitis in active phase - | Patients with ulcerative colitis in active phase | Z-206 2.4g/day dose group: Two Z-206 400mg tablets, 1 tablet of Z-206 placebo tablet, 3 tablets of Pentasa placebo tablet per time (total 6 tablets). 3 times a day (t.i.d.) after each meal for 8 weeks. Z-206 3.6g/day dose group: Three tablets of Z-206 400mg tablet, 3 tablets of Pentasa placebo tablet per time (total 6 tablets). 3 times a day (t.i.d.) after each meal for 8 weeks. Mesalazine group: Three tablets of Pentasa 250 mg tablet and 3 tablets of Z-206 placebo tablet per time (total 6 tablets). 3 times a day (t.i.d.) after each meal for 8 weeks. Placebo group: Three tablets of Z-206 placebo tablet and 3 tablets of Pentasa placebo tablet per time (total 6 tablets). 3 times a day (t.i.d.) after each meal for 8 weeks. | Zeria Pharmaceutical Co.,LTD. | Not Recruiting | 16years-old | 64years-old | Male and Female | 210 | Phase 3 | Japan | ||
| 750 | JPRN-C000000289 | 2005/12/01 | 2 April 2019 | Z-206 Phase III Clinical Trial - Investigation on the remission-maintaining effect in patients with ulcerative colitis in remission phase - | Patients with ulcerative colitis in remission phase. | Z-206 group : Two Z-206 400 mg tablets, 3 tablets of Pentasa placebo tablet per time (total 5 tablets). 3 times a day (t.i.d.) after each meal for 48 weeks. Mesalazine group: Three tablets of Pentasa 250 mg tablet and 2 tablets of Z-206 placebo tablet per time (total 5 tablets). 3 times a day (t.i.d.) after each meal for 48 weeks. | Zeria Pharmaceutical Co.,LTD. | Not Recruiting | 16years-old | 64years-old | Male and Female | 120 | Phase 3 | Japan | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 751 | NCT00269438 | December 2005 | 19 February 2015 | New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis | Phase 3 Study to Establish the Efficacy and Safety of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium Dosed Twice Daily in Achieving Clinical Improvement in Subjects With Mildly to Moderately Active Ulcerative Colitis After 8 Weeks of Therapy | Ulcerative Colitis | Drug: 5 ASA, enemas, suppositories, corticosteroids | Salix Pharmaceuticals | Not recruiting | 18 Years | 80 Years | Both | 225 | Phase 3 | United States | |
| 752 | NCT00326209 | December 2005 | 8 January 2018 | Long-Term Safety and Tolerability of Mesalamine Pellets in Patients With Ulcerative Colitis in Remission | A Multicenter, Open-Label, Treatment Extension Trial to Evalaute the Long-Term Safety and Tolerability of Mesalamine Pellet Formulation | Ulcerative Colitis | Drug: Mesalamine pellets | Valeant Pharmaceuticals International, Inc. | Not recruiting | 18 Years | N/A | All | 394 | Phase 3 | United States | |
| 753 | NCT00309660 | November 2005 | 19 February 2015 | Treatment With Local PPARgamma Ligand in Distal Ulcerative Colitis | Ulcerative Colitis | Drug: Rosiglitazone | Herlev Hospital | Recruiting | 18 Years | 80 Years | Both | 20 | Phase 1/Phase 2 | Denmark | ||
| 754 | EUCTR2005-003724-19-HU | 24/10/2005 | 19 March 2012 | A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis - 197-02-218 Protocol | A Phase 3, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects with Active Ulcerative Colitis - 197-02-218 Protocol | Active Ulcerative Colitis MedDRA version: 8.0 Level: LLT Classification code 10058816 | Product Name: OPC-6535 Product Code: OPC-6535 Pharmaceutical Form: Coated tablet INN or Proposed INN: Not applicable CAS Number: N/A Current Sponsor code: OPC-6535 Other descriptive name: OPC-6535 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use | Otsuka Maryland Research Institute, Inc. | Authorised | Female: yes Male: yes | 375 | Phase 3 | Hungary | |||
| 755 | EUCTR2004-005032-35-GB | 11/10/2005 | 1 May 2012 | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | Moderate acute ulcerative colitis. | Product Name: COLAL-PRED Product Code: ATL-2502 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Prednisolone sodium metasulphobenzoate CAS Number: 630-67-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Prednisolone Tablets B.P. 5mg Product Name: Prednisolone Pharmaceutical Form: Tablet INN or Proposed INN: Prednisolone CAS Number: 50-24-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: COLAL-PRED Product Code: ATL-2502 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Prednisolone sodium metasulphobenzoate CAS Number: 630-67-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 60- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: COLAL-PRED Product Code: ATL-2502 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Prednisolone sodium metasulphobenzoate CAS Number: 630-67-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Alizyme Therapeutics Limited | Authorised | Female: yes Male: yes | 890 | Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 756 | NCT00254618 | October 2005 | 19 February 2015 | A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis. | Study to Determine the Pharmacokinetics of Mesalamine Following Administration of 30, 60, and 90 mg/kg/Day as 400 mg Delayed-release Tablets Given Every 12 Hours for 28 Days to Children/Adolescents With Active Ulcerative Colitis. | Ulcerative Colitis | Drug: mesalamine | Warner Chilcott | Not recruiting | 5 Years | 17 Years | Both | 34 | Phase 1 | United States | |
| 757 | EUCTR2005-000695-40-GB | 27/09/2005 | 24 April 2012 | A randomised trial of aminosalicylate withdrawal in patients with ulcerative colitis in established remission on combination treatment of azathioprine (or 6-mercaptopurine) and an aminosalicylate - CASA trial | A randomised trial of aminosalicylate withdrawal in patients with ulcerative colitis in established remission on combination treatment of azathioprine (or 6-mercaptopurine) and an aminosalicylate - CASA trial | The medical condition is Ulcerative Colitis. | Product Name: products containing azathioprine or 6-mercaptopurine Pharmaceutical Form: Tablet INN or Proposed INN: azathioprine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- INN or Proposed INN: azathioprine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- INN or Proposed INN: 6-mercaptopurine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Product Name: Products containing aminosalicylate Pharmaceutical Form: Tablet INN or Proposed INN: Sulphsalazine, Pentasa, Asacol, Colazide, Depentum Concentration number: withdrawal of IMP- | University of Nottingham | Authorised | Female: yes Male: yes | United Kingdom | |||||
| 758 | NCT00928681 | September 2005 | 19 February 2015 | A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis | A Randomized, Double-Blind (Sponsor Open), Placebo Controlled, Dose Escalating, Parallel Group, Multi-Centre Study To Investigate The Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Single And Multiple Intravenous/Sub-Cutaneous Doses Of PF-00547659 In Patients With Active Ulcerative Colitis. | Colitis, Ulcerative | Biological: Single dose-group A;Biological: Multiple dose- Group B;Biological: Multiple dose-Group B | Pfizer | Not recruiting | 18 Years | 70 Years | Both | 80 | Phase 1 | Belgium;Czech Republic;Denmark;Germany;Norway;Slovakia;Spain | |
| 759 | EUCTR2004-000734-36-CZ | 13/07/2005 | 19 March 2012 | A phase III, randomized, multi-center, open-label, 12 to 14 months extension study to evaluate the safety and tolerability of SPD476 (mesalazine) give once daily vs. twice daily for the maintenance of ulcerative colitis in remission. | A phase III, randomized, multi-center, open-label, 12 to 14 months extension study to evaluate the safety and tolerability of SPD476 (mesalazine) give once daily vs. twice daily for the maintenance of ulcerative colitis in remission. | Subject not in remission of Ulcerative Colitis (UC-DAI score of >1) at the End of Study/Early Withdrawal Visit of Study 301 or 302. Subject in remission of UC (UC-DAI<1 with a score of 0 for rectal bleeding and stool frequency, and at least a 1 point reduction in the sigmoidocsopy score from Study 301 or 302 baseline) at the End of Study Visit of Study 301 or 302, or at the end of the Acute Phase of this study | Product Name: Mesalazine Product Code: SPD476 Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: Mesalazinum CAS Number: 89-57-6 Current Sponsor code: SPD476 Other descriptive name: 5-amino salicylic acid (5-ASA) Concentration unit: g gram(s) Concentration type: equal Concentration number: 1.2- Pharmaceutical form of the placebo: Prolonged-release tablet Route of administration of the placebo: Oral use | Shire Pharmaceutical Development Inc. | Authorised | Female: yes Male: yes | 125 | Phase 3 | Czech Republic | |||
| 760 | NCT00167882 | July 2005 | 19 February 2015 | The Influence of 5–Aminosalicylates on Thiopurine Metabolite Levels | Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease | Drug: 5-aminosalicylate (Pentasa, Ferring) | VU University Medical Center | Not recruiting | 18 Years | 70 Years | Both | 24 | Phase 4 | Netherlands | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 761 | EUCTR2004-001216-31-DE | 30/05/2005 | 19 March 2012 | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Double-blind, double-dummy, randomised, multicentre, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus three times daily 1.0 g mesalazine granules in patients with active ulcerative colitis - OD vs. TID dosing with mesalazine granules in active UC | Therapy of active ulcerative colitis MedDRA version: 7.1 Level: LLT Classification code 10058816 | Trade Name: Salofalk® 1000mg Granu-Stix® Pharmaceutical Form: Gastro-resistant granules INN or Proposed INN: Mesalazine CAS Number: 89-57-6 Other descriptive name: 5-Aminosalicylic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000- Pharmaceutical form of the placebo: Gastro-resistant granules Route of administration of the placebo: Oral use Product Name: 1500mg mesalazine pellets Pharmaceutical Form: Gastro-resistant granules INN or Proposed INN: Mesalazine CAS Number: 89-57-6 Other descriptive name: 5-Aminosalicylic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1500- Product Name: 500mg mesalazine pellets Pharmaceutical Form: Gastro-resistant granules INN or Proposed INN: Mesalazine CAS Number: 89-57-6 Other descriptive name: 5-Aminosalicylic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- | Dr. Falk Pharma GmbH | Not Recruiting | Female: yes Male: yes | 320 | Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania | ||||
| 762 | NCT00618202 | May 2005 | 29 January 2018 | A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions | A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Balsalazide Disodium 750 mg Capsules Under Fasting Conditions | Ulcerative Colitis | Drug: Balsalazide | Roxane Laboratories | Not recruiting | 18 Years | 45 Years | All | 52 | N/A | United States | |
| 763 | NCT00829595 | May 2005 | 19 February 2015 | Pneumococcal Vaccination in Patients With Inflammatory Bowel Disease | Pneumococcal Vaccination in Patients With Inflammatory Bowel Disease | Inflammatory Bowel Disease;Crohn Disease;Ulcerative Colitis | Biological: 23-valent polysaccharide pneumococcal vaccine (Pneumovax TM) | Cedars-Sinai Medical Center | Not recruiting | 18 Years | N/A | Both | 69 | N/A | United States | |
| 764 | EUCTR2004-004565-15-NO | 06/04/2005 | 24 April 2012 | Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM | Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission: PODIUM An International multi-centre investigator blinded randomised controlled study of Pentasa ® Sachet comparing one gram twice with two gram once daily - PODIUM | Ulcerative collitis (UC) MedDRA version: 4.1 Level: PT Classification code 10009900 | Trade Name: Pentasa sachet 1g Product Name: Pentasa Pharmaceutical Form: Prolonged-release granules INN or Proposed INN: mesalazine Other descriptive name: 5-AminoSalicylic Acid Trade Name: NA Product Name: Pentasa prolonged release granules 2g Pharmaceutical Form: Prolonged-release granules INN or Proposed INN: mesalazine | Ferring BV | Not Recruiting | Female: yes Male: yes | 360 | Finland;Germany;Czech Republic;Denmark;Norway;Sweden | ||||
| 765 | EUCTR2004-001218-15-DE | 04/04/2005 | 19 March 2012 | Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC | Double-blind, double-dummy, randomised, multicentre, 12-months, comparative study of the efficacy and tolerability of once daily 3.0 g mesalazine granules versus once daily 1.5 g mesalazine granules versus three times daily 0.5 g mesalazine granules for maintenance of remission in patients with ulcerative colitis - OD vs. TID dosing with mesalazine granules for prevention of recurrence of UC | Maintenance therapy of ulcerative colitis | Pharmaceutical Form: Gastro-resistant granules INN or Proposed INN: Mesalazine CAS Number: 89-57-6 Other descriptive name: 5-Aminosalicylic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Pharmaceutical form of the placebo: Gastro-resistant granules Route of administration of the placebo: Oral use Product Name: 1500mg mesalazine pellets Pharmaceutical Form: Gastro-resistant granules INN or Proposed INN: Mesalazine CAS Number: 89-57-6 Other descriptive name: 5-Aminosalicylic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1500- Product Name: 750mg mesalazine pellets Pharmaceutical Form: Gastro-resistant granules INN or Proposed INN: Mesalazine CAS Number: 89-57-6 Other descriptive name: 5-Aminosalicylic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 750- Product Name: 250mg mesalazine pellets Pharmaceutical Form: Gastro-resistant granules INN or Proposed INN: Mesalazine CAS Number: 89-57-6 Other descriptive name: 5-Aminosalicylic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- | Dr. Falk Pharma GmbH | Not Recruiting | Female: yes Male: yes | 510 | Hungary;Germany;Estonia;Latvia;Lithuania | ||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 766 | NCT00232258 | April 2005 | 19 February 2015 | Nolpitantium Besylate In Patients With Ulcerative Colitis a Double-Blind, Placebo Controlled Efficacy and Safety Study | Nolpitantium Besylate in Patients With Mild to Moderate Ulcerative Colitis, a Double-Blind, Placebo Controlled Efficacy and Safety, 8 Week Study | Ulcerative Colitis;Inflammatory Bowel Disease | Drug: Nolpitantium besylate | Sanofi | Not recruiting | 18 Years | N/A | Both | 307 | Phase 2 | Argentina;Belgium;Brazil;Canada;Chile;Czech Republic;Estonia;Hungary;Italy;Russian Federation;Singapore;South Africa;Spain;Sweden;France;United States | |
| 767 | EUCTR2004-004184-29-HU | 30/03/2005 | 1 May 2012 | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA | Ulcerative colitis MedDRA version: 9.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis | Trade Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets. Product Name: Mezavant XL 1200 mg gastro-resistant, prolonged release tablets Product Code: SPD476 Pharmaceutical Form: Modified-release tablet INN or Proposed INN: Mesalazine CAS Number: 89-57-6 Current Sponsor code: SPD476 Other descriptive name: 5-amino salicylic acid Concentration unit: g gram(s) Concentration type: equal Concentration number: 1.2- Pharmaceutical form of the placebo: Modified-release tablet Route of administration of the placebo: Oral use Trade Name: Asacol Delayed Release Tablets Product Name: Asacol Pharmaceutical Form: Modified-release tablet INN or Proposed INN: Mesalazine CAS Number: 89-57-6 Other descriptive name: 5-aminosalicylic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Modified-release tablet Route of administration of the placebo: Oral use | Shire Pharmaceutical Development Ltd | Authorised | Female: yes Male: yes | 826 | Phase 3 | Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden | |||
| 768 | EUCTR2004-004077-29-LT | 09/02/2005 | 8 May 2012 | A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis | A Double-blind, Randomized, Multicenter, Active-control, 56-day Study with a 28-day Follow-up to Assess the Efficacy and Safety of RDP58 200 mg/day plus Mesalazine 2.4 g/day and RDP58 600 mg/day plus Mesalazine 2.4 g/day Each Compared to Mesalazine 4.8 g/day for the Treatment of Moderately Active Ulcerative Colitis - RDP58 + Mesalazine v. Mesalazine for Treatment of Moderately Active Ulcerative Colitis | Ulcerative colitis is characterized by acute and chronic inflammatory changes to the mucosa and submucosa of the colon and rectum. Clinical presentations include increased stool frequency, bloody diarrhea, and abdominal or rectal pain. | Product Name: RDP58 Product Code: RDP58 Pharmaceutical Form: Capsule, soft INN or Proposed INN: Delmitide acetate CAS Number: 501019-16-5 Current Sponsor code: RDP58 Other descriptive name: SF257 C59 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use Product Name: mesalazine Pharmaceutical Form: Tablet INN or Proposed INN: Mesalazine CAS Number: 89-57-6 Other descriptive name: 5-Aminosalicylic Acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 800- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Procter & Gamble Pharmaceuticals | Not Recruiting | Female: yes Male: yes | 250 | United Kingdom;Czech Republic;Germany;Lithuania | ||||
| 769 | EUCTR2004-001677-26-HU | 25/01/2005 | 19 March 2012 | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study. - NICE | Patients with 5-aminosalicylic acid (5-ASA) or sulphasalazine resistant ulcerative colitis. MedDRA version: 7.0 Level: LLT Classification code 10045365 | Product Name: Nolpitantium besylate Product Code: SR140333B Pharmaceutical Form: Tablet INN or Proposed INN: Nolpitantium besylate CAS Number: 155418-06-7 Current Sponsor code: SR140333B Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200--of active moiety Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Sanofi-Synthelabo Recherche | Authorised | Female: yes Male: yes | 300 | Hungary;Czech Republic;Estonia;Spain;Italy;Sweden | ||||
| 770 | NCT00457171 | December 2004 | 19 February 2015 | GI-270384 Study In Patients With Mild To Moderate Ulcerative Colitis | A Double-Blind, Placebo-Controlled Phase I/II Study in Patients With Mild to Moderate Ulcerative Colitis Treated With GI-270384X, an Oral ICAM-1 and E-Selectin Inhibitor | Ulcerative Colitis | Drug: GI-270384 | GlaxoSmithKline | Not recruiting | 18 Years | 55 Years | Both | 16 | Phase 1 | Netherlands | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 771 | NCT00744016 | December 2004 | 19 February 2015 | Mesalamine Pellet Formulation to Maintain Remission of Mild to Moderate Ulcerative Colitis | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Use of Mesalamine Pellet Formulation 1.5G QD to Maintain Remission From Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: Granulated mesalamine;Drug: Placebo | Salix Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 305 | Phase 3 | United States | |
| 772 | NCT00767728 | December 2004 | 19 February 2015 | Mesalamine Pellet to Maintain Remission of Mild to Moderate Ulcerative Colitis | A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Use of Mesalamine Pellet Formulation 1.5G QD to Maintain Remission From Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: Granulated mesalamine;Drug: Placebo | Salix Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | 256 | Phase 3 | United States | |
| 773 | EUCTR2004-000611-25-HU | 15/10/2004 | 19 March 2012 | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25mg QD and 50mg QD of OPC-6535 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Remission in Subjects with Ulcerative Colitis. - CORE | Maintenance of remission of ulcerative colitis | Product Name: OPC-6535 Product Code: OPC-6535 Pharmaceutical Form: Tablet Current Sponsor code: OPC-6535 Other descriptive name: 6-[2-(3,4-diethoxyphenyl)thiazol-4-yl] pyridine-2-carboxylic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Asacol (mesalamine) Delayed-release Tablets Product Name: Asacol Pharmaceutical Form: Capsule, hard INN or Proposed INN: Mesalamine Other descriptive name: 5-amino-2-hydroxybenzoic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Otsuka Maryland Research Institute, Inc. | Not Recruiting | Female: yes Male: yes | 1725 | Phase 3 | Hungary;Ireland | |||
| 774 | EUCTR2004-000916-25-IT | 28/09/2004 | 19 March 2012 | A PHASE III PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUPS, STUDY, TO ASSESS THE EFFECT OF 5-ASA MMx 1.2 g Tablets IN MAINTENANCE OF REMISSION OF LEFT-SIDED ULCERATIVE COLITIS | A PHASE III PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUPS, STUDY, TO ASSESS THE EFFECT OF 5-ASA MMx 1.2 g Tablets IN MAINTENANCE OF REMISSION OF LEFT-SIDED ULCERATIVE COLITIS | TREATMENT OF ULCERATIVE COLITIS IN ACTIVE PHASE AND IN THE MAINTENANCE OF CLINICAL REMISSION MedDRA version: 6.1 Level: PT Classification code 10021972 | Product Name: 5-ASA MMx Pharmaceutical Form: Modified-release tablet INN or Proposed INN: Mesalazine CAS Number: 89-57-6 Concentration unit: g gram(s) Concentration type: equal Concentration number: 1.2- | GIULIANI | Not Recruiting | Female: yes Male: yes | Phase 3 | Italy | ||||
| 775 | NCT00207688 | August 31, 2004 | 16 July 2018 | A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients | A Multicenter International Study of the Long-term Safety of Infliximab (REMICADE) in Ulcerative Colitis | Ulcerative Colitis | Drug: Infliximab 5 mg/kg;Drug: Infliximab 10 mg/kg;Drug: Placebo | Janssen Research & Development, LLC | Janssen Biologics BV | Not recruiting | N/A | N/A | All | 505 | Phase 2 | United States;Argentina;Australia;Austria;Belgium;Canada;Czechia;Denmark;France;Germany;Israel;Netherlands;New Zealand;Switzerland;United Kingdom;Czech Republic |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 776 | EUCTR2004-000733-12-CZ | 14/07/2004 | 19 March 2012 | A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis. | A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis. | Subjects who have newly diagnosed or have a diagnosis of relapsing (relapses | Product Name: Mesalazine Product Code: SPD476 Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: Mesalazinum CAS Number: 89-57-6 Current Sponsor code: SPD476 Other descriptive name: 5-amino salicylic acid (5-ASA) Concentration unit: g gram(s) Concentration type: equal Concentration number: 1.2- Pharmaceutical form of the placebo: Prolonged-release tablet Route of administration of the placebo: Oral use | Shire Pharmaceutical Development Inc | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | Czech Republic | |||
| 777 | NCT00268164 | June 2004 | 25 May 2015 | Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis | Lactobacillus Acidophilus and Bifidobacterium Animalis Subsp. Lactis, Maintenance Treatment in Ulcerative Colitis | Ulcerative Colitis | Drug: lactobacilus acidophilus & bifidobacterium animalis/lactis | Hvidovre University Hospital | Chr Hansen A/S | Not recruiting | 18 Years | N/A | Both | 48 | Phase 2 | Denmark |
| 778 | NCT00092508 | May 2004 | 19 February 2015 | CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission | Phase 3, Multi-Center, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25 mg QD and 50 mg QD of OPC-6335 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Ulcerative Colitis Remission | Ulcerative Colitis | Drug: OPC-6535;Drug: Asacol® | Otsuka Pharmaceutical Development & Commercialization, Inc. | Not recruiting | 18 Years | 80 Years | Both | 1725 | Phase 3 | United States | |
| 779 | NCT00261118 | April 2004 | 19 February 2015 | Rituximab in Active Ulcerative Colitis | Phase 3: Randomised Controlled Trial of Rituximab in Active Ulcerative Colitis | Ulcerative Colitis | Drug: Rituximab | Royal Liverpool University Hospital | Hoffmann-La Roche;University of Liverpool | Not recruiting | 18 Years | N/A | Both | 24 | Phase 2/Phase 3 | United Kingdom |
| 780 | NCT00114803 | January 2004 | 19 February 2015 | Nasal Calcitonin in the Treatment of Bone Mineral Loss in Children and Adolescents With Inflammatory Bowel Disease | Use of Intranasally Administered Calcitonin in the Treatment of Osteopenia and Osteoporosis in Children, Adolescents and Young Adults With IBD: A Pilot Study | Ulcerative Colitis;Crohn's Disease | Drug: Calcitonin nasal spray (salmon) | Children's Hospital Boston | Crohn's and Colitis Foundation;National Institutes of Health (NIH) | Not recruiting | 8 Years | 22 Years | Both | 66 | N/A | United States |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 781 | NCT00267306 | January 2004 | 19 February 2015 | Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative Colitis | A Phase 1/2, Partially Randomized, Open-Label Study of Visilizumab in Patients With Severe Ulcerative Colitis Refractory to Intravenous Corticosteroids | Severe Ulcerative Colitis | Drug: Visilizumab | Facet Biotech | PDL BioPharma, Inc. | Not recruiting | 16 Years | 70 Years | Both | 144 | Phase 1/Phase 2 | United States |
| 782 | NCT00618228 | January 2004 | 29 January 2018 | Bioequivalency Study of Balsalazide Capsules Under Fasting Conditions | A Single Dose, Two-Period, Two-Treatment, Randomized Crossover Bioequivalency Study of 750 mg Balsalazide Capsules Under Fasting Conditions | Ulcerative Colitis | Drug: Balsalazide | Roxane Laboratories | Not recruiting | 18 Years | 45 Years | All | 52 | N/A | United States | |
| 783 | NCT00548574 | December 2003 | 16 March 2015 | Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to Asacol 0.8g Three Times Daily in Subjects With Acute, Mild to Moderate Ulcerative Colitis | A Phase III, Randomized, Multi-Centre, Double-blind, Double Dummy, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Two Doses of SPD476 (Mesalazine) 2.4g and 4.8g Once Daily, With Reference to ASACOL 0.8g Three Times Daily, in Subjects With Mild to Moderate Ulcerative Colitis | Ulcerative Colitis | Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine;Drug: Mesalazine | Shire | Not recruiting | 18 Years | N/A | Both | 343 | Phase 3 | Belgium | |
| 784 | JPRN-C000000078 | 2003/10/01 | 2 April 2019 | Antibiotic Combination Therapy in Patients with Active Refractory Ulcerative Colitis: A Prospective Randomized Placebo-controlled Multicenter Study | Ulcerative Colitis | Patients in the treatment group receive an antibiotic combination consisting of amoxicillin 500mg tid, tetracycline 500mg tid, and metronidazole 250mg tid for two weeks. patients in the control group recieve three kinds of placebo contained sugar. | Japan UC Antibiotics-therapy Study Group(JUCASG) | Nihon University,Iwate Medical University, Kyoto Central Hospital Yamagata Central Hospital Oita University, Tokyo Medical University Toyama Medical & Pharmaceutical University, Showa University | Not Recruiting | 15years-old | 70years-old | Male and Female | 210 | Phase 2 | Japan | |
| 785 | NCT00063414 | September 2003 | 19 February 2015 | ISIS 2302-CS22, A 6-Week, Active-Controlled Clinical Study to Evaluate the Effectiveness of Alicaforsen (ISIS 2302) in Patients With Mild to Moderate Active Ulcerative Colitis | ISIS 2302-CS22, Phase II, Double-Blinded, Active-Controlled Study of Alicaforsen (ISIS 2302) Enema, an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Mild to Moderate Active Ulcerative Colitis (Left-Sided Colitis or Pancolitis With Left Sided Disease Flare) | Ulcerative Colitis | Drug: Alicaforsen | Isis Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | Phase 2 | United States | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 786 | NCT00063830 | June 2003 | 19 February 2015 | ISIS 2302-CS27, A 6-Week, Placebo-Controlled Clinical Study to Evaluate the Effectiveness of Alicaforsen (ISIS 2302) in Patients With Mild to Moderate Active Ulcerative Colitis. | ISIS 2302-CS27, Phase 2, Double-Blinded, Controlled Study of Four Dosing Regimens of Alicaforsen (ISIS 2302) Enema, an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Mild to Moderate Active Ulcerative Colitis | Ulcerative Colitis | Drug: Alicaforsen | Isis Pharmaceuticals | Not recruiting | 18 Years | N/A | Both | Phase 2 | United States | ||
| 787 | NCT00194818 | June 2003 | 19 February 2015 | Asacol Dosing Study for Active Ulcerative Colitis | Open Label Safety and Efficacy Trial of Twice Daily Dosing of Asacol vs. Three Times Per Day Dosing for the Induction of Remission in Active Ulcerative Colitis | Ulcerative Colitis | Drug: Asacol (mesalamine) | University of Washington | Procter and Gamble | Not recruiting | 18 Years | 80 Years | Both | 7 | Phase 4 | United States |
| 788 | NCT00064441 | May 2003 | 19 February 2015 | FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis | FACTS I: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Drug: OPC-6535 Tablets (drug) | Otsuka Pharmaceutical Development & Commercialization, Inc. | Not recruiting | 18 Years | 80 Years | Both | 375 | Phase 3 | United States | |
| 789 | NCT00064454 | May 2003 | 19 February 2015 | FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis | FACTS II: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects With Active Ulcerative Colitis | Ulcerative Colitis | Drug: OPC-6535 Tablets (drug) | Otsuka Pharmaceutical Development & Commercialization, Inc. | Not recruiting | 18 Years | 80 Years | Both | 375 | Phase 3 | United States | |
| 790 | NCT00073047 | April 2003 | 19 February 2015 | Humanized Anti-IL-2 Receptor Monoclonal Antibody in Moderate-to-severe Ulcerative Colitis | A Phase II, Randomized, Double-blind, Placebo-controlled, Multi-center, Dose-ranging Study of Intravenous Daclizumab in Patients With Moderate-to-severe Ulcerative Colitis | Ulcerative Colitis;Gastrointestinal Disease;Inflammatory Bowel Disease | Drug: Daclizumab | Facet Biotech | Not recruiting | 12 Years | N/A | Both | 150 | Phase 2 | United States;Belgium;Canada | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 791 | NCT00259558 | April 2003 | 19 February 2015 | Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis | Prospektive, Randomisierte Doppelblinde Studie Zur Dosisfindung Von Intestinal Redardiert Freigesetztem Phosphatidylcholin Bei Chronisch Aktiver Pancolitis Ulcerosa | Ulcerative Colitis | Drug: retarded release phosphatidylcholine | Heidelberg University | Prof. Wolfgang Stremmel;Dietmar Hopp Stiftung | Not recruiting | 16 Years | 90 Years | Both | 60 | Phase 2 | Germany |
| 792 | NCT00259571 | April 2003 | 19 February 2015 | Retarded Phosphatidylcholine Versus Mesalazin in Remission of Ulcerative Colitis. | Prospektive, Randomisierte, Doppelblinde, Mesalazin-kontrollierte (Double-dummy Verfahren) Multizenter-Studie Zur Beurteilung Der Annahme Der äquivalenten Wirkung Von Intestinal Retardiert Freigesetztem Phosphatidylcholin gegenüber Mesalazin (Non-inferiority Study) in Der Remissionserhaltung Der Colitis Ulcerosa. | Ulcerative Colitis | Drug: retarded release phosphatidylcholine | Heidelberg University | Dietmar Hopp Stiftung | Not recruiting | 15 Years | 80 Years | Both | 0 | Phase 2/Phase 3 | Germany |
| 793 | NCT01171807 | April 2003 | 19 February 2015 | Erythrocytes-Mediated Delivery Of Dexamethasone 21-Phosphate In Steroid-Dependent Ulcerative Colitis | PHASE 2 STUDY OF DEXAMETHASONE 21-PHOSPHATE LOADED INTO AUTOLOGOUS ERYTHROCYTES IN STEROID-DEPENDENT ULCERATIVE COLITIS PATIENTS | Ulcerative Colitis | Drug: Dexamethasone 21-phosphate | Casa Sollievo della Sofferenza IRCCS | Recruiting | 18 Years | 80 Years | Both | 40 | Phase 2 | Italy | |
| 794 | NCT00259545 | February 2003 | 19 February 2015 | Retarded Phosphatidylcholine in Steroid-Dependent Chronic Active Ulcerative Colitis | Prospektive, Randomisierte Doppelblinde Studie Zur Wirksamkeit Von Intestinal Retardiert Freigesetztem Phosphatidylcholine Bei therapierefraktärer Colitis Ulcerosa Mit Chronisch Aktivem Verlauf Unter Corticosteroiden | Ulcerative Colitis;Phosphatidylcholine | Drug: Retarded Release Phosphatidylcholine (rPC) | Heidelberg University | Professor Wolfgang Stremmel;Dietmar Hopp Stiftung | Not recruiting | 16 Years | 90 Years | Both | 60 | Phase 2 | Germany |
| 795 | NCT00545389 | February 2003 | 19 February 2015 | Phase II Dose-Ranging Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 | A Phase II, Randomized, Multi-Centre, Double-Blind, Parallel-Group, Dose-Ranging, Exploratory Study in Subjects With Mild to Moderate Ulcerative Colitis Treated With SPD476 (Mesalazine) Once Daily | Colitis, Ulcerative | Drug: SPD476 is a polymeric matrix formulation that displays both delayed- and extended-release of mesalazine | Shire | Not recruiting | 18 Years | N/A | Both | 38 | Phase 2 | Belgium | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 796 | NCT00048347 | October 2002 | 19 October 2017 | Interferon-beta1a (AVONEX) Treatment of Ulcerative Colitis | An Open-Label, Pilot Study of Type I Interferon (AVONEX) Treatment of Ulcerative Colitis | Ulcerative Colitis | Drug: AVONEX | National Institute of Allergy and Infectious Diseases (NIAID) | Not recruiting | 18 Years | N/A | All | 18 | Phase 2 | United States | |
| 797 | NCT00061282 | September 2002 | 30 September 2019 | Clotrimazole Enemas for Pouchitis in Children and Adults | Clotrimazole Enemas for Pouchitis in Children and Adults | Ulcerative Colitis;Pouchitis;Ileitis;Inflammatory Bowel Disease | Drug: Clotrimazole | Paul Rufo | Not recruiting | 2 Years | N/A | All | 40 | Phase 1/Phase 2 | United States | |
| 798 | NCT00065065 | September 2002 | 16 December 2017 | A Trial of Rosiglitazone for Ulcerative Colitis | A Randomized, Placebo-controlled Trial of Rosiglitazone for Treatment of Ulcerative Colitis | Ulcerative Colitis;Inflammatory Bowel Disease | Drug: Rosiglitazone;Drug: Placebo | James Lewis | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);GlaxoSmithKline | Not recruiting | 18 Years | N/A | All | 105 | Phase 2 | United States |
| 799 | NCT00152841 | June 2002 | 19 February 2015 | Effect of Iron and Vitamin E Supplementation on Disease Activity in Patients With Either Crohn's Disease or Ulcerative Colitis | Effect of Iron and Antioxidant Vitamins on Disease Activity and Oxidative Stress in Inflammatory Bowel Disease (IBD) | Crohn's Disease;Ulcerative Colitis;Mild or Moderate Anaemia | Drug: Iron supplement 300-600 mg/day;Drug: Vitamin E 800IU | University Health Network, Toronto | Crohn's and Colitis Foundation | Not recruiting | 18 Years | N/A | Both | 30 | Phase 2 | Canada |
| 800 | NCT00096655 | May 2002 | 19 February 2015 | A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Ulcerative Colitis | A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis | Ulcerative Colitis | Drug: Infliximab | Centocor, Inc. | Not recruiting | 18 Years | N/A | Both | 364 | Phase 3 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 801 | NCT00032305 | March 2002 | 19 February 2015 | Research Study in Patients With Severe Ulcerative Colitis | A Phase I, Dose-Escalation, Pilot Study of Visilizumab in Patients With Severe Ulcerative Colitis That is Refractory to Corticosteroids | Ulcerative Colitis | Drug: Visilizumab | Facet Biotech | Not recruiting | 18 Years | 70 Years | Both | 20 | Phase 2/Phase 3 | United States | |
| 802 | NCT00036439 | February 2002 | 19 February 2015 | A Safety and Efficacy Study for Infliximab (Remicade) in Patients With Active Ulcerative Colitis | A Randomized, Placebo-controlled, Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis | Ulcerative Colitis | Drug: Infliximab | Centocor, Inc. | Not recruiting | 18 Years | N/A | Both | 364 | Phase 3 | United States;Belgium | |
| 803 | NCT00510978 | January 2002 | 19 February 2015 | Probiotics in GastroIntestinal Disorders | One Year, Randomised, Double Blind, Placebo Controlled Trial of Probiotics, Bifidobacterium Infantis 35624 or Lactobacillus Salivarius UCC118, as Food Supplements for Maintenance of Remission in Crohn's Disease and Ulcerative Colitis | Ulcerative Colitis;Crohn's Disease | Biological: Bifidobacterium infantis 35624;Biological: Lactobacillus salivarius UCC118;Biological: Placebo | University College Cork | European Commission | Not recruiting | N/A | 75 Years | Both | 360 | Phase 2/Phase 3 | Ireland |
| 804 | NCT00303381 | December 2001 | 19 February 2015 | Safety and Efficacy of Interferon-Beta-1a (Rebif®) for Treating Subjects With Acute Symptoms of Ulcerative Colitis | A Multicentre, Randomised, Double-blind, Placebo-controlled, Dose-finding Phase II Study of Subcutaneously Administered IFN-beta-1a in the Treatment of Patients With Moderately Active Ulcerative Colitis | Ulcerative Colitis | Drug: Interferon-beta-1a, 44 microgram;Drug: Placebo;Drug: Interferon-beta-1a, 66 microgram | EMD Serono | Merck Serono International SA | Not recruiting | 18 Years | N/A | Both | 194 | Phase 2 | Germany;Israel;Netherlands;Singapore;Sweden;Switzerland;United Kingdom;Spain |
| 805 | NCT00577473 | February 2001 | 19 October 2017 | Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I) | A Double-blind, Randomized, 6 Week, Parallel-group Design Clinical Trial in Patients With Mildly to Moderately Active Ulcerative Colitis to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day | Ulcerative Colitis | Drug: mesalamine | Warner Chilcott | Not recruiting | 18 Years | 65 Years | All | 301 | Phase 3 | United States | |
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 806 | NCT00033943 | January 2001 | 19 February 2015 | Safety and Efficacy of OP2000 (Deligoparin) in the Treatment of Active Ulcerative Colitis | A Multi-Center, Placebo-Controlled Evaluation of the Safety and Efficacy of Two Dosage Levels of OP2000 (75 Mg and 125 Mg) Administered Once Daily by Subcutaneous Injection for the Treatment of Active Ulcerative Colitis | Ulcerative Colitis | Drug: deligoparin | Incara Pharmaceuticals | Not recruiting | 18 Years | 60 Years | Both | 270 | Phase 2/Phase 3 | United States | |
| 807 | NCT00073021 | September 2000 | 19 October 2017 | Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis | A Double-Blind, Randomized, 6-Week, Parallel-Group Design Clinical Trial to Assess Safety and Efficacy of Asacol 4.8 g/Day (800 mg Tablet) Versus Asacol 2.4 g/Day (400 mg Tablet) for the Treatment of Moderately Active Ulcerative Colitis | Ulcerative Colitis | Drug: Asacol 800 mg (mesalamine);Drug: Asacol 400 mg (mesalamine) | Warner Chilcott | Not recruiting | 18 Years | 75 Years | All | 386 | Phase 3 | United States;Canada;Puerto Rico | |
| 808 | NCT00940576 | July 2000 | 19 October 2017 | Dietetic Efficacy of Mare's Milk for Patients With Chronic Inflammatory Bowel Diseases | Dietetic Effects of Mare's Milk in Patients With Chronic Inflammatory Bowel Diseases (IBD) - a Double Blind Placebo Controlled Cross-over Study. | Ulcerative Colitis;Crohns Disease | Dietary Supplement: mare´s milk;Other: placebo drink | University of Jena | German Federal Ministry of Education and Research | Not recruiting | 10 Years | 50 Years | All | 17 | N/A | Germany |
| 809 | NCT00463619 | April 2000 | 19 February 2015 | Follow-up Study With Retarded Release Phosphatidylcholine in Ulcerative Colitis | Ulcerative Colitis | Drug: Retarded release phosphatidylcholine | Heidelberg University | Not recruiting | 16 Years | N/A | Both | 132 | N/A | Germany | ||
| 810 | NCT00004810 | June 1996 | 19 February 2015 | Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis | Ulcerative Colitis | Drug: -aminosalicylic acid | National Center for Research Resources (NCRR) | University of Vermont | Not recruiting | 18 Years | 80 Years | Both | 30 | Phase 2 | ||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 811 | NCT00038922 | September 1994 | 19 February 2015 | Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Safety and Exploratory Pharmacogenomic Study of Orally Administered Recombinant Human Interleukin Eleven (rhIL-11) in Patients With Mild to Moderate Left-Sided Ulcerative Colitis | Ulcerative Colitis;Inflammatory Bowel Disease | Drug: rhIL-11 | Wyeth is now a wholly owned subsidiary of Pfizer | Not recruiting | 18 Years | N/A | Both | Phase 1 | United States | ||
| 812 | JPRN-JapicCTI-060298 | 23 April 2019 | Clinical study to assess the efficacy and safety of TA-650 in patients with active ulcerative colitis | Clinical study to assess the efficacy and safety of TA-650 in patients with active ulcerative colitis | Ulcerative colitis | Intervention name : TA-650 (Infliximab) Dosage And administration of the intervention : Intravenous drip infusion | Mitsubishi Tanabe Pharma Corporation | 16 | BOTH | Phase 3 | ||||||
| 813 | JPRN-JapicCTI-070399 | 23 April 2019 | An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis | An Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis | Active ulcerative colitis | Intervention name : Rebamipide Dosage And administration of the intervention : Intracolonial (enema) | Otsuka Pharmaceutical Co., Ltd. | 16 | BOTH | Phase 2 | ||||||
| 814 | JPRN-JapicCTI-090967 | 2 April 2019 | PS-QD Phase3 Clinical Study -Investigation to find new dosage and administration of mesalazine for the treatment of patients with Ulcerative Colitis in remission phase.- | PS-QD Phase3 Clinical Study -Investigation to find new dosage and administration of mesalazine for the treatment of patients with Ulcerative Colitis in remission phase.- | ulcerative colitis | Intervention name : PS-QD Dosage And administration of the intervention : Mesalazine at the dose 1500mg/day or 2250mg/day is administered once a day or three times a day. Control intervention name : null | Kyorin Pharmaceutical Co.,LTD | 15 | 64 | BOTH | Phase 3 | |||||
| 815 | JPRN-JapicCTI-101144 | 23 April 2019 | Phase II/III induction study of AJG501 in patients with active ulcerative colitis | Phase II/III induction study of AJG501 in patients with active ulcerative colitis | Ulcerative colitis | Intervention name : AJG501 Dosage And administration of the intervention : oral Control intervention name : Mesalazine tablet Dosage And administration of the control intervention : oral | Ajinomoto Pharmaceuticals Co., Ltd. | 16 | 64 | BOTH | Phase 2-3 | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 816 | JPRN-JapicCTI-121943 | 23 April 2019 | Phase II Study of Z-206 | Phase II Study of Z-206 | Ulcerative colitis | Intervention name : Z-206 INN of the intervention : Mesalazine Dosage And administration of the intervention : oral | Zeria Pharmaceutical Co., Ltd. | Kyowa Hakko Kirin Co., Ltd. | BOTH | Phase 2 | ||||||
| 817 | JPRN-JapicCTI-132294 | 23 April 2019 | Phase II study of AJG511 in patients with active ulcerative colitis | Phase II study of AJG511 in patients with active ulcerative colitis | Ulcerative colitis | Intervention name : AJG511 INN of the intervention : budesonide Dosage And administration of the intervention : intrarectal | Ajinomoto Pharmaceuticals Co., Ltd. | 16 | 69 | BOTH | Phase 2 | |||||
| 818 | JPRN-JapicCTI-184062 | 16 July 2019 | A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis | A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Intervention name : mirikizumab Dosage And administration of the intervention : Mirikizumab administered subcutaneously (SC). | Eli Lilly Japan K.K. | Recruiting | 18 | 80 | BOTH | Phase 3 | ||||
| 819 | JPRN-JapicCTI-184216 | 16 July 2019 | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (I6T-MC-AMAN) | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients with Moderately to Severely Active Ulcerative Colitis (I6T-MC-AMAN) | Ulcerative Colitis | Intervention name : LY3074828 INN of the intervention : mirikizumab Dosage And administration of the intervention : intravenous injection Control intervention name : Placebo INN of the control intervention : Placebo Dosage And administration of the control intervention : intravenous injection | Eli Lilly Japan K.K. | Recruiting | 18 | 80 | BOTH | Phase 3 | ||||
| 820 | JPRN-JapicCTI-184217 | 16 July 2019 | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (I6T-MC-AMBG) | A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm, Placebo-Controlled Maintenance Study of Mirikizumab in Patients with Moderately to Severely Active Ulcerative Colitis (I6T-MC-AMBG) | Ulcerative Colitis | Intervention name : LY3074828 INN of the intervention : mirikizumab Dosage And administration of the intervention : intravenous injection, Subcutaneous injection Control intervention name : Placebo INN of the control intervention : Placebo Dosage And administration of the control intervention : intravenous injection, Subcutaneous injection | Eli Lilly Japan K.K. | Not Recruiting | 18 | 80 | BOTH | Phase 3 |