97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
臨床試験数 : 2,630 / 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05753267 (ClinicalTrials.gov) | February 28, 2023 | 22/2/2023 | Fenofibrate in Ulcerative Colitis | Clinical Study to Evaluate the Possible Efficacy of Fenofibrate in Patient With Ulcerative Colitis | Inflammatory Bowel Diseases | Drug: Mesalamine;Drug: Fenofibrate 160mg | Tanta University | Eman Ibrahim Elberri, Faculty of Pharmacy, Tanta University;Hend El-Said Abo Mansour, Faculty of Pharmacy, Menoufia University;Monir Hussein Bahgat, Faculty of Medicine, Mansura University;Eman Maamoun Ali El-Khateeb, Lecturer of Clinical Pharmacy, Faculty of Pharmacy, Tanta University | Recruiting | 18 Years | 75 Years | All | 60 | Phase 2/Phase 3 | Egypt |
| 2 | NCT05567068 (ClinicalTrials.gov) | February 1, 2023 | 1/10/2022 | Atorvastatin Efficacy and Safety in Patients With Ulcerative Colitis | Repurposing Atorvastatin in Patients With Ulcerative Colitis Treated With Mesalamine by Modulation of mTOR/NLRP3 Pathway. | Inflammatory Bowel Diseases | Drug: Atorvastatin 80mg;Drug: Mesalamine | Tanta University | NULL | Not yet recruiting | 18 Years | 75 Years | All | 44 | Phase 2 | NULL |
| 3 | NCT05574387 (ClinicalTrials.gov) | January 20, 2023 | 6/10/2022 | Metformin as Added on Therapy in Patients With Ulcerative Colitis | Metformin, The Biguanide Derivative, as Adjuvant Therapy in Patients With Ulcerative Colitis Treated With Mesalamine | Inflammatory Bowel Diseases | Drug: Metformin | Tanta University | Principal Investigator Sahar El-Haggar, Prof Clinical pharmacy Department- Tanta University;Principal Investigator Sahar Hegazy, Prof Clinical pharmacy Department- Tanta University;Principal Investigator Mostafa Mahmoud Bahaa El-Dien Pharmacy Practice Department- Horus University | Recruiting | 18 Years | 75 Years | All | 46 | Phase 2 | Egypt |
| 4 | NCT05316220 (ClinicalTrials.gov) | December 31, 2022 | 31/3/2022 | A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis | A Randomized, Double-blind Study to Assess the Safety and Efficacy of Mesalamine Delayed-release Capsules in Children Aged 5 to 17 Years for the Maintenance of Remission of Ulcerative Colitis | Ulcerative Colitis (UC) | Drug: Mesalamine;Drug: Placebo | AbbVie | NULL | Not yet recruiting | 5 Years | 17 Years | All | 80 | Phase 3 | United States;Puerto Rico |
| 5 | NCT05561062 (ClinicalTrials.gov) | December 1, 2022 | 27/9/2022 | Atorvastatin in Patients With Ulcerative Colitis | Combination of Atorvastatin and Mesalazine to Enhance Anti-inflammatory Effects and Attenuates Progression of Ulcerative Colitis | Inflammatory Bowel Diseases | Drug: Atorvastatin 80mg | Tanta University | NULL | Not yet recruiting | 18 Years | 75 Years | All | 50 | Phase 2 | NULL |
| 6 | NCT05553704 (ClinicalTrials.gov) | November 1, 2022 | 20/9/2022 | Metformin in Patients With Ulcerative Colitis Treated With Mesalamine | Clinical Study to Compare the Possible Efficacy of Metformin in Patients With Ulcerative Colitis Treated With Mesalamine | Inflammatory Bowel Diseases | Drug: Metformin | Tanta University | NULL | Recruiting | 18 Years | 75 Years | All | 52 | Phase 2 | Egypt |
| 7 | NCT05626166 (ClinicalTrials.gov) | November 2022 | 9/11/2022 | the Efficacy and Safety of Diosmin in Patients With Ulcerative Colitis | Clinical Study Evaluating the Efficacy and Safety of Diosmin in Patients With Ulcerative Colitis Treated With Mesalamine | Ulcerative Colitis | Drug: Placebo;Drug: Diosmin | Tanta University | NULL | Not yet recruiting | 18 Years | N/A | All | 60 | Phase 3 | NULL |
| 8 | NCT05558761 (ClinicalTrials.gov) | October 10, 2022 | 25/9/2022 | Pentoxifylline as Adjunctive Therapy in Patients With Ulcerative Colitis | Clinical Study to Evaluate the Possible Efficacy of Pentoxifylline in Patients With Ulcerative Colitis Treated With Mesalamine | Inflammatory Bowel Diseases | Drug: Pentoxifylline 400 MG | Tanta University | NULL | Recruiting | 18 Years | 75 Years | All | 50 | Phase 2 | Egypt |
| 9 | NCT05119140 (ClinicalTrials.gov) | June 10, 2022 | 20/10/2021 | HCQ for Non Europeans With Mild to Severe UC | Administration of Hydroxychloroquine (Plaquenil) to Individuals of Non-European Ancestry for the Treatment of Mild to Severe Ulcerative Colitis. | Ulcerative Colitis (Disorder) | Drug: Hydroxychloroquine;Drug: Mesalamine | Icahn School of Medicine at Mount Sinai | Crohn's and Colitis Foundation | Recruiting | 18 Years | N/A | All | 20 | Phase 1/Phase 2 | United States |
| 10 | ChiCTR2100048502 | 2021-07-15 | 2021-07-09 | Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials | Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials | Ulcerative Colitis | Experimental group:SLBZP Granule and Mesalazine;Control group:Mesalazine; | The First Affiliated Hospital of Guangzhou University of Chinese Medicine | NULL | Pending | 18 | 75 | Both | Experimental group:3;Control group:3; | N/A | China |
| 11 | ITMCTR2100005038 | 2021-07-15 | 2021-07-09 | Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials | Modified Shenling Baizhu Powder in the Treatment of Ulcerative Colitis in the Remission Phase: a Series of N-of-1 Randomized, Controlled Trials | Ulcerative Colitis | Experimental group:SLBZP Granule and Mesalazine;Control group:Mesalazine; | The First Affiliated Hospital of Guangzhou University of Chinese Medicine | NULL | Pending | 18 | 75 | Both | Experimental group:3;Control group:3; | N/A | China |
| 12 | EUCTR2019-003334-16-LV (EUCTR) | 29/04/2021 | 14/01/2021 | Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitis | Randomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis | acute 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: Budenofalk® suppositories INN or Proposed INN: BUDESONIDE Other descriptive name: Budenofalk® suppositories (BUS) Trade Name: Salofalk 3g gastro-resistant prolonged-release granules Product Name: Salofalk 3g gastro-resistant prolonged-release granules INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;Poland;Ukraine;Bulgaria;Russian Federation;Germany;Latvia | ||
| 13 | EUCTR2019-003334-16-BG (EUCTR) | 11/03/2021 | 02/12/2020 | Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitis | Randomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis | acute 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: Budenofalk® suppositories INN or Proposed INN: BUDESONIDE Other descriptive name: Budenofalk® suppositories (BUS) Trade Name: Salofalk 3g gastro-resistant prolonged-release granules Product Name: Salofalk 3g gastro-resistant prolonged-release granules INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Belarus;Poland;Ukraine;Russian Federation;Bulgaria;Germany;Latvia | ||
| 14 | ChiCTR2000039161 | 2020-10-30 | 2020-10-20 | Effect of Kangfuxin Liquid enema combined with mesalazine on gestational outcomes and quality of life in child-bearing female with active ulcerative colitis: a randomized, double-blind, controlled trial | A systematic study on the criteria of syndrome differentiation of kidney Yang deficiency in infertility | Ulcerative colitis | control group:Mesalazine enteric-coated tablets + placebo enema;experimental group:Mesalazine enteric-coated tablets +Kangfuxin Liquid enema; | Chengdu University of Traditional Chinese Medicine | NULL | Recruiting | 20 | 45 | Female | control group:118;experimental group:118; | China | |
| 15 | ChiCTR2000038888 | 2020-10-19 | 2020-10-09 | Effect of Kangfuxin Liquid enema combined with mesalazine on gestational outcomes and quality of life in child -bearing female with active ulcerative colitis: a randomized, double-blind, controlled trial | A systematic study on the criteria of syndrome differentiation of kidney yang deficiency in infertility | Ulcerative colitis | control group:Mesalazine enteric-coated tablets + placebo enema;experimental group:Mesalazine enteric-coated tablets +Kangfuxin Liquid enema; | Chengdu University of Traditional Chinese Medicine | NULL | Recruiting | 20 | 45 | Female | control group:118;experimental group:118; | China | |
| 16 | ChiCTR2000036950 | 2020-10-01 | 2020-08-25 | Study of Jianpi Huashi Decoction and Mesalazine on Ulcerative Colitis Patients with Spleen Deficiency and Damp-Heat Type | Study of Jianpi Huashi Decoction and Mesalazine on Ulcerative Colitis Patients with Spleen Deficiency and Damp-Heat Type | Uicerative colitis | Jianpi Huashi Decoction Group:Jianpi Huashi Decoction;Mesalazine Group:Mesalazine; | Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of TCM | NULL | Recruiting | Both | Jianpi Huashi Decoction Group:45;Mesalazine Group:45; | China | |||
| 17 | ITMCTR2000003714 | 2020-10-01 | 2020-08-25 | Study of Jianpi Huashi Decoction and Mesalazine on Ulcerative Colitis Patients with Spleen Deficiency and Damp-Heat Type | Study of Jianpi Huashi Decoction and Mesalazine on Ulcerative Colitis Patients with Spleen Deficiency and Damp-Heat Type | Uicerative colitis | Mesalazine Group:Mesalazine;Jianpi Huashi Decoction Group:Jianpi Huashi Decoction; | Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of TCM | NULL | Recruiting | Both | Mesalazine Group:45;Jianpi Huashi Decoction Group:45; | China | |||
| 18 | NCT05538026 (ClinicalTrials.gov) | September 1, 2020 | 9/9/2022 | Effectiveness of Fecal Microbiota Transplantation as add-on Therapy in Mild-to-moderate Ulcerative Colitis | Efficacy and Safety of Fecal Microbiota Transplantation as add-on Therapy in Patients With Mild-To-Moderate Ulcerative Colitis: A Randomized, Clinical Trial | Ulcerative Colitis Chronic Mild;Inflammatory Bowel Diseases | Drug: Mesalazine;Biological: Fecal transplantation | Bogomolets National Medical University | Ukrainian Research and Practical Centre of Endocrine Surgery, Transplantation of Endocrine Organs and Tissues of the Ministry of Health of Ukraine | Completed | 18 Years | 60 Years | All | 53 | N/A | Ukraine |
| 19 | ITMCTR2000003530 | 2020-08-01 | 2020-07-31 | Study on TCM accurate syndrome differentiation and treatment scheme of ulcerative colitis based on intestinal microecology and multi-omics technology | Study on TCM accurate syndrome differentiation and treatment scheme of ulcerative colitis based on intestinal microecology and multi-omics technology | Uicerative colitis | qi deficiency syndrome control group:Mesalazine;damp-heat syndrome control group:Mesalazine;healthy control group:nil;qi deficiency syndrome treatment group:Modified Shenling Baizhu Powder and Mesalazine;ulcerative colitis damp-heat syndrome group:nil;damp-heat syndrome treatment group:Modified Gegenqinlian Decoction and Mesalazine;ulcerative colitis qi deficiency syndrome group:nil; | Jiangsu Province Hospital of Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | qi deficiency syndrome control group:30;damp-heat syndrome control group:30;healthy control group:30;qi deficiency syndrome treatment group:60;ulcerative colitis damp-heat syndrome group:30;damp-heat syndrome treatment group:60;ulcerative colitis qi defi | China | |
| 20 | ChiCTR2000035099 | 2020-08-01 | 2020-07-31 | Study on TCM accurate syndrome differentiation and treatment scheme of ulcerative colitis based on intestinal microecology and multi-omics technology | Study on TCM accurate syndrome differentiation and treatment scheme of ulcerative colitis based on intestinal microecology and multi-omics technology | Uicerative colitis | ulcerative colitis damp-heat syndrome group:nil;ulcerative colitis qi deficiency syndrome group:nil;healthy control group:nil;damp-heat syndrome treatment group:Modified Gegenqinlian Decoction and Mesalazine;damp-heat syndrome control group:Mesalazine;qi deficiency syndrome treatment group:Modified Shenling Baizhu Powder and Mesalazine;qi deficiency syndrome control group:Mesalazine; | Jiangsu Province Hospital of Chinese Medicine | NULL | Recruiting | 18 | 65 | Both | ulcerative colitis damp-heat syndrome group:30;ulcerative colitis qi deficiency syndrome group:30;healthy control group:30;damp-heat syndrome treatment group:60;damp-heat syndrome control group:30;qi deficiency syndrome treatment group:60;qi deficiency s | China | |
| 21 | NCT05386290 (ClinicalTrials.gov) | July 9, 2020 | 17/5/2022 | A Multicentered Prospective Cohort Study of Chinese IBD Patients | A Multicentered Prospective Cohort Study of Chinese IBD Patients Concerning Cost-effectiveness Analysis, Therapeutic Effect Predictor Exploration and Gut Microbiota Analysis | Ulcerative Colitis;Crohn Disease | Drug: Infliximab;Drug: Vedolizumab;Drug: Ustekinumab;Drug: conventional treatment (glucocoticoid, immunosupressive drugs and/or mesalazine) | Peking Union Medical College Hospital | NULL | Enrolling by invitation | 14 Years | 80 Years | All | 200 | China | |
| 22 | EUCTR2019-003334-16-DE (EUCTR) | 26/06/2020 | 05/05/2020 | Novel budenosid suppository in addition to basic therapy with oral mesalazine compared to basic therapy alone for treatment of ulcerative colitis | Randomised, double-blind, placebo-controlled, multicentre study to compare the efficacy and safety of novel 4 mg budesonide suppository in combination with oral mesalazine versus oral mesalazine monotherapy in patients with acute ulcerative colitis | acute 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: Budenofalk® suppositories INN or Proposed INN: BUDESONIDE Other descriptive name: Budenofalk® suppositories (BUS) Trade Name: Salofalk 3g gastro-resistant prolonged-release granules Product Name: Salofalk 3g gastro-resistant prolonged-release granules INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Phase 3 | Belarus;Poland;Ukraine;Russian Federation;Bulgaria;Latvia;Germany | ||
| 23 | ChiCTR2000028767 | 2020-04-27 | 2020-01-03 | A randomized, controlled trial for evaluating the efficacy and safety of oseltamivir in the treatment of ulcerative colitis | A randomized, controlled trial for evaluating the efficacy and safety of oseltamivir in the treatment of ulcerative colitis | ulcerative colitis | Experimental group:Oseltamivir and mesalazine;Control group:mesalazine; | Xiangya Hospital of Central South University | NULL | Recruiting | 18 | 75 | Both | Experimental group:53;Control group:53; | N/A | China |
| 24 | NCT03980405 (ClinicalTrials.gov) | April 1, 2020 | 5/6/2019 | 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 | NULL | Terminated | 10 Years | 19 Years | All | 12 | N/A | Israel |
| 25 | ITMCTR2000002903 | 2020-01-03 | 2020-01-05 | phase IIa clinical trial of Colitis Suppositories | A multicenter, randomized, blinded management, positive-drug parallel-controlled, preliminary exploratory phase IIa clinical trial on the efficacy and safety of Colitis Suppositories in the treatment for mild-to-moderate active ulcerative colitis (Qi-Deficiency and Blood-Stasis Syndrome), compared with the Mesalazine Suppositories (Salofalk) | mild-to-moderate active ulcerative colitis (Qi-Deficiency and Blood-Stasis Syndrome) | The control group:Mesalazine Suppositories, one at a time, twice a day, in the early and late anal plug into the rectum.;Experimental group:Colitis Suppositories, one at a time, twice a day, in the early and late anal plug into the rectum.; | Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University | NULL | Recruiting | 18 | 65 | Both | The control group:30;Experimental group:30; | Phase 2 | China |
| 26 | ChiCTR2000028869 | 2020-01-03 | 2020-01-05 | phase IIa clinical trial of Colitis Suppositories | A multicenter, randomized, blinded management, positive-drug parallel-controlled, preliminary exploratory phase IIa clinical trial on the efficacy and safety of Colitis Suppositories in the treatment for mild-to-moderate active ulcerative colitis (Qi-Deficiency and Blood-Stasis Syndrome), compared with the Mesalazine Suppositories (Salofalk) | mild-to-moderate active ulcerative colitis (Qi-Deficiency and Blood-Stasis Syndrome) | Experimental group:Colitis Suppositories, one at a time, twice a day, in the early and late anal plug into the rectum.;The control group:Mesalazine Suppositories, one at a time, twice a day, in the early and late anal plug into the rectum.; | Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University | NULL | Recruiting | 18 | 65 | Both | Experimental group:30;The control group:30; | Phase 2 | China |
| 27 | NCT04133194 (ClinicalTrials.gov) | November 28, 2019 | 10/10/2019 | 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 | Flemming Bendtsen | NULL | Recruiting | 18 Years | 60 Years | All | 200 | Phase 4 | Denmark |
| 28 | EUCTR2019-002070-31-DK (EUCTR) | 05/09/2019 | 24/06/2019 | Compliance to treatment with new single-pill 5-ASA for patients with Ulcerative Colitis (EASI-trial) | Adherence of a 1.600 mg single tablet 5-ASA treatment of Ulcerative colitis (EASI-trial) | Ulcerative colitis (UC) belongs to the group of inflammatory bowel diseases. The disease course is unpredictable and characterised by chronic inflammation of the colonic mucosa, where acute attacks are followed by periods of remission. Development of UC is characterized by a dysregulated immune response and barrier dysfunction caused by genetic susceptibility and environmental triggers. UC only involves the colon, starting in the rectum and extending to proximal segments of the colon.;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Asacol® INN or Proposed INN: MESALAZINE | Copenhagen University Hospital Hvidovre | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 4 | Denmark | ||
| 29 | ITMCTR1900002423 | 2019-08-01 | 2019-06-24 | 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 | NULL | Pending | 18 | 75 | Both | intervention period:10;control period:10; | N/A | China |
| 30 | ChiCTR1900024086 | 2019-08-01 | 2019-06-24 | 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 | NULL | Pending | 18 | 75 | Both | intervention period:10;control period:10; | N/A | China |
| 31 | NCT03923478 (ClinicalTrials.gov) | June 24, 2019 | 15/4/2019 | 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 | NULL | Terminated | 18 Years | 70 Years | All | 15 | Phase 1 | United States;Canada |
| 32 | EUCTR2017-004576-57-PL (EUCTR) | 18/05/2019 | 01/08/2019 | Novel budesonide capsules vs. budesonide tabltes 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 prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 777 | Phase 3 | Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany | ||
| 33 | NCT03917095 (ClinicalTrials.gov) | May 15, 2019 | 12/4/2019 | 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 | Device: The Colonic Transendoscopic enteral Tubing.;Drug: Glutamine;Drug: Mesalazine | The Second Hospital of Nanjing Medical University | NULL | Recruiting | 18 Years | 65 Years | All | 75 | N/A | China |
| 34 | EUCTR2017-004576-57-DE (EUCTR) | 26/04/2019 | 08/01/2019 | Novel budesonide capsules vs. budesonide tablets 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 prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 777 | Phase 3 | Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany | ||
| 35 | EUCTR2017-004576-57-LV (EUCTR) | 15/04/2019 | 14/01/2019 | Novel budesonide capsules vs. budesonide tablets 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 prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 777 | Phase 3 | Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Germany;Latvia | ||
| 36 | EUCTR2017-004576-57-CZ (EUCTR) | 27/03/2019 | 15/03/2019 | Novel budesonide capsules vs. budesonide tablets 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 prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 777 | Phase 3 | Serbia;Czechia;Hungary;Czech Republic;Slovakia;Poland;Ukraine;Lithuania;Turkey;Russian Federation;Latvia;Germany | ||
| 37 | EUCTR2017-004576-57-LT (EUCTR) | 15/03/2019 | 29/01/2019 | Novel budesonide capsules vs. budesonide tablets 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 prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsule, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 777 | Phase 3 | Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany | ||
| 38 | EUCTR2017-004576-57-SK (EUCTR) | 12/03/2019 | 18/01/2019 | Novel budesonide capsules vs. budesonide tablets 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 prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 777 | Phase 3 | Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany | ||
| 39 | EUCTR2017-004576-57-HU (EUCTR) | 11/03/2019 | 16/01/2019 | Novel budesonide capsules vs. budesonide tablets 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 prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Product Name: Budesonide 6 mg prolonged-release capsules, hard (BUX-PVII prototype) INN or Proposed INN: BUDESONIDE Trade Name: CortimentMMX 9 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 777 | Phase 3 | Czech Republic;Hungary;Slovakia;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany | ||
| 40 | ChiCTR1900021229 | 2019-02-18 | 2019-02-02 | 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 | NULL | Pending | Both | Intervention group:74;Control group:74; | China | |||
| 41 | NCT03716388 (ClinicalTrials.gov) | December 1, 2018 | 21/10/2018 | 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 |
| 42 | JPRN-UMIN000034016 | 2018/12/01 | 03/09/2018 | 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 | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 84 | Not selected | Japan |
| 43 | ChiCTR1800016438 | 2018-06-30 | 2018-06-01 | 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 | NULL | Pending | 15 | 75 | Both | control:30;observation group:30; | China | |
| 44 | NCT04969679 (ClinicalTrials.gov) | March 16, 2018 | 7/7/2021 | Additive Effect of Probiotics (Mutaflor®) in Patients With Ulcerative Colitis on 5-ASA Treatment. | A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Effect of Mutaflor in Patients With Mild-to-moderate Ulcerative Colitis on 5-ASA Treatment. | Ulcerative Colitis | Drug: E. coli Nissle 1917 (Mutaflor®);Drug: Placebo | Kangbuk Samsung Hospital | NULL | Completed | 19 Years | N/A | All | 134 | Phase 4 | Korea, Republic of |
| 45 | JPRN-JapicCTI-173803 | 14/3/2018 | 08/12/2017 | 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. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | MOCHIDA PHARMACEUTICAL CO., LTD | NULL | complete | 16 | BOTH | 26 | Phase 2-3 | Japan | |
| 46 | NCT03412682 (ClinicalTrials.gov) | March 2, 2018 | 22/1/2018 | 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 | NULL | Completed | 16 Years | 75 Years | All | 274 | Phase 3 | Japan |
| 47 | JPRN-JapicCTI-173802 | 30/1/2018 | 08/12/2017 | 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. Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : - | MOCHIDA PHARMACEUTICAL CO., LTD | NULL | complete | 16 | BOTH | 26 | Phase 2-3 | Japan | |
| 48 | EUCTR2013-001744-65-BE (EUCTR) | 23/01/2018 | 27/02/2017 | A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases | Mild to Moderate 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: Mezavant Gastro-resistant, prolonged release tablets Product Name: Mezavant Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden | ||
| 49 | EUCTR2013-001744-65-DE (EUCTR) | 10/01/2018 | 20/02/2017 | A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases | 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] | Trade Name: Mezavant Gastro-resistant, prolonged release tablets Product Name: Mezavant Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden | ||
| 50 | ChiCTR2100043797 | 2018-01-01 | 2021-02-28 | The efficacy and mechanism of fecal microbiota transplantation in the treatment of patients with ulcerative colitis | The efficacy and mechanism of fecal microbiota transplantation in the treatment of patients with ulcerative colitis | Ulcerative colitis | Case series:Single or multiple FMT were performed via the working channel of the colonoscope or transendoscopic enteral tubing in 2 months. All patients were given concomitant oral mesalamine (4g/d) and patients who were taking corticosteroid did a mandatory taper of 2.5 mg per week until it was withdrawn.; | Department of Gastroenterology, Jinan Central Hospital | NULL | Completed | 21 | 81 | Both | Case series:28; | N/A | China |
| 51 | JPRN-UMIN000026175 | 2017/06/23 | 01/03/2017 | 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 | NULL | Complete: follow-up complete | 20years-old | 99years-old | Male and Female | 60 | Not applicable | Japan |
| 52 | NCT03104036 (ClinicalTrials.gov) | June 19, 2017 | 27/3/2017 | 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 | Completed | 18 Years | 70 Years | All | 61 | Phase 2 | Czechia;Czech Republic |
| 53 | NCT03110198 (ClinicalTrials.gov) | May 2017 | 19/2/2017 | 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 |
| 54 | NCT03415711 (ClinicalTrials.gov) | April 28, 2017 | 5/1/2018 | 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. | Terminated | 18 Years | 85 Years | All | 14 | N/A | Italy |
| 55 | EUCTR2015-002557-35-BG (EUCTR) | 14/03/2017 | 06/01/2017 | A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis | 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 | Active, mild to moderate ulcerative colitis MedDRA version: 20.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland | ||
| 56 | EUCTR2015-002558-11-BG (EUCTR) | 14/03/2017 | 06/01/2017 | A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis | 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 MedDRA version: 20.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 2g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland | ||
| 57 | NCT02910245 (ClinicalTrials.gov) | November 2016 | 9/9/2016 | Mercaptopurine Therapy in Ulcerative Colitis | Efficacy of Optimized Thiopurine Therapy in Ulcerative Colitis (OPTIC) | Colitis, Ulcerative | Drug: Mercaptopurine (Purinethol);Drug: Placebo;Drug: Mesalamine;Drug: Prednisone | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | ZonMw: The Netherlands Organisation for Health Research and Development | Recruiting | 18 Years | 80 Years | All | 136 | Phase 3 | Netherlands |
| 58 | EUCTR2015-002558-11-LV (EUCTR) | 01/09/2016 | 01/07/2016 | A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis | 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 MedDRA version: 19.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 2g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | Serbia;United States;Belarus;Ukraine;Ireland;Lithuania;Russian Federation;Switzerland;Hungary;Mexico;Canada;Belgium;Bulgaria;Latvia | ||
| 59 | EUCTR2015-002557-35-LV (EUCTR) | 01/09/2016 | 01/07/2016 | A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis | 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 | Active, mild to moderate ulcerative colitis MedDRA version: 19.0;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Serbia;United States;Belarus;Ukraine;Ireland;Lithuania;Russian Federation;Switzerland;Hungary;Mexico;Canada;Belgium;Bulgaria;Latvia | ||
| 60 | NCT02849951 (ClinicalTrials.gov) | July 2016 | 26/7/2016 | 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 | Terminated | 18 Years | 70 Years | All | 25 | Phase 3 | United States |
| 61 | NCT02665845 (ClinicalTrials.gov) | June 13, 2016 | 25/1/2016 | 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 | NULL | Completed | 18 Years | N/A | All | 160 | Phase 3 | France;Greece;Israel;Italy;Korea, Republic of;Serbia |
| 62 | EUCTR2013-001205-84-BE (EUCTR) | 11/03/2016 | 17/02/2015 | 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: 17.1;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 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | 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 | ||
| 63 | EUCTR2013-001205-84-HU (EUCTR) | 07/03/2016 | 04/01/2016 | 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: 18.1;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 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Hungary;Belgium;Poland;Germany;Latvia;Netherlands | ||
| 64 | EUCTR2015-002558-11-HU (EUCTR) | 09/02/2016 | 16/11/2015 | 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 | 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 MedDRA version: 19.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 2g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | United States;Serbia;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland | ||
| 65 | EUCTR2015-002557-35-HU (EUCTR) | 09/02/2016 | 16/11/2015 | A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis | 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 | Active, mild to moderate ulcerative colitis MedDRA version: 19.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Serbia;United States;Hungary;Mexico;Canada;Belgium;Ukraine;Russian Federation;Bulgaria;Latvia;Switzerland | ||
| 66 | NCT02522780 (ClinicalTrials.gov) | February 1, 2016 | 12/8/2015 | 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 | NULL | Completed | 18 Years | 75 Years | All | 276 | Phase 3 | United States;Bulgaria;Canada;Hungary;Latvia;Mexico;Poland;Russian Federation;Serbia;Switzerland;Ukraine;Belgium |
| 67 | NCT02683733 (ClinicalTrials.gov) | February 2016 | 10/2/2016 | 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 | NULL | Recruiting | 18 Years | 70 Years | Both | 50 | Phase 3 | India |
| 68 | JPRN-UMIN000022954 | 2016/01/15 | 05/07/2016 | A study related to usability of Mesalazine Controlled-Release Tablets and Granules. | A study related to usability of Mesalazine Controlled-Release Tablets and Granules. - 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 | NULL | Complete: follow-up complete | Not applicable | 100years-old | Male and Female | 60 | Not applicable | Japan |
| 69 | EUCTR2015-002558-11-BE (EUCTR) | 07/12/2015 | 04/11/2015 | A study to investigate the efficacy and safety of Mesalamine 2 g extended release granules (Sachet) for maintenance of clinical and endoscopic remission in Ulcerative Colitis | 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 MedDRA version: 18.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 2g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 260 | Phase 3 | United States;Slovakia;Ukraine;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Latvia;New Zealand;Korea, Republic of | ||
| 70 | EUCTR2015-002557-35-BE (EUCTR) | 07/12/2015 | 04/11/2015 | A study to investigate the efficacy and safety of Mesalamine 4 g extended release granules (Sachet) for the induction of clinical and endoscopic remission in mild to moderate Ulcerative Colitis | 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 | Active, mild to moderate ulcerative colitis MedDRA version: 18.1;Level: LLT;Classification code 10058816;Term: Colitis ulcerative acute episode;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Pentasa Compact 4g, granulate with prolonged release INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-aminosalicylic acid [5-ASA] | Ferring International PharmaScience Center U.S., Inc. | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | United States;Slovakia;Ukraine;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Latvia | ||
| 71 | EUCTR2015-001022-42-IT (EUCTR) | 01/12/2015 | 29/03/2019 | 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 INN or Proposed INN: SODIUM HYALURONATE Other descriptive name: SODIUM HYALURONATE INN or Proposed INN: MESALAZINE Other descriptive name: Mesalamine, 5-ASA | Holy Stone Healthcare Co., Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 51 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Italy | ||
| 72 | NCT02368743 (ClinicalTrials.gov) | December 2015 | 16/2/2015 | 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 | NULL | Completed | 18 Years | N/A | All | 117 | France | |
| 73 | JPRN-UMIN000019310 | 2015/11/01 | 01/11/2015 | Randomized controlled study for concomitant use of 5-aminosalicylic acid suppository with increased dose of oral 5-aminosalicylic acid for moderate to severe patients with ulcerative colitis | Randomized controlled study for concomitant use of 5-aminosalicylic acid suppository with increased dose of oral 5-aminosalicylic acid for moderate to severe patients with ulcerative colitis - Randomized controlled study for concomitant use of 5-ASA suppository with increased dose of oral 5-ASA for moderate to severe patients with ulcerative colitis | ulcerative colitis | Arm A: Increase of oral 5-ASA (oral administration of 5-ASA in a maximum dose for 8 weeks) Arm B: Increase of oral 5-ASA and addition of 5-ASA suppository (oral administration of 5-ASA in a maximum dose for 8 weeks and topical administration of 1 g of 5-ASA suppository for 4 weeks) | Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 90 | Not selected | Japan |
| 74 | EUCTR2013-001205-84-AT (EUCTR) | 13/10/2015 | 02/09/2015 | 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: 18.0;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 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | 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 | ||
| 75 | ChiCTR-ICR-15007188 | 2015-10-09 | 2015-10-09 | 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 | NULL | Recruiting | Both | Percutaneous endoscopic mini-colostomy group:21;Control Group:21; | China | |||
| 76 | NCT02522767 (ClinicalTrials.gov) | October 2015 | 12/8/2015 | 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 | NULL | Completed | 18 Years | 75 Years | All | 228 | Phase 3 | United States;Bulgaria;Canada;Hungary;Latvia;Mexico;Poland;Russian Federation;Serbia;Switzerland;Ukraine;Belgium |
| 77 | NCT02537210 (ClinicalTrials.gov) | September 2015 | 28/8/2015 | 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 |
| 78 | JPRN-UMIN000018075 | 2015/06/26 | 25/06/2015 | Significance of optimal therapy for ulcerative colitis patients with clinical remission who have colonic active lesions | Significance of optimal therapy for ulcerative colitis patients with clinical remission who have colonic active lesions - Clinical trial for UC-AC | Ulcerative colitis | normal dosage of 5-ASA (dosage for maintenance therapy) to maximaum dosage of 5-ASA no optimized therapy | Center for Diagnostic and Therapeutic Endoscopy,Keio University | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 100 | Not selected | Japan |
| 79 | EUCTR2013-000366-11-RO (EUCTR) | 25/03/2015 | 11/03/2015 | 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: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Serbia;Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 80 | EUCTR2013-001205-84-SK (EUCTR) | 23/03/2015 | 05/02/2015 | 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: 19.0;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 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | 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 | ||
| 81 | EUCTR2013-001744-65-NL (EUCTR) | 02/03/2015 | 07/08/2014 | A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases | Mild to Moderate 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] | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine | Shire Devlopment LLC | NULL | Not Recruiting | Female: yes Male: yes | 128 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Canada;Belgium;Poland;Israel;Germany;Netherlands;United Kingdom | ||
| 82 | NCT02368717 (ClinicalTrials.gov) | March 2015 | 16/2/2015 | 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 | NULL | Completed | 18 Years | 70 Years | All | 281 | Phase 3 | China |
| 83 | EUCTR2013-001205-84-LV (EUCTR) | 26/02/2015 | 23/12/2014 | 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: 17.1;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 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Belgium;Poland;Latvia;Germany;Netherlands | ||
| 84 | EUCTR2013-001205-84-PL (EUCTR) | 20/01/2015 | 22/09/2014 | 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: 18.1;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 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Poland;Belgium;Germany;Latvia;Netherlands | ||
| 85 | EUCTR2013-001205-84-DE (EUCTR) | 13/01/2015 | 08/08/2014 | 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 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE Trade Name: Salofalk Granu-Stix 500 mg INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | 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 | ||
| 86 | NCT04276649 (ClinicalTrials.gov) | January 1, 2015 | 17/2/2020 | A Retrospective Analysis: the Influence of Caltrate Supplement on the Effect of Mesalazine in Ulcerative Colitis | A Retrospective Analysis on the Influence of Caltrate Supplement on the Clinical Effect of Mesalazine in Ulcerative Colitis | Ulcerative Colitis;Vitamin D Deficiency;Vitamin D Supplement | Drug: Caltrate | Second Affiliated Hospital of Wenzhou Medical University | NULL | Completed | 18 Years | N/A | All | 74 | China | |
| 87 | NCT03441893 (ClinicalTrials.gov) | January 1, 2015 | 8/2/2018 | 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;Drug: Placebo tabletes | Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan | NULL | Active, not recruiting | 18 Years | 90 Years | All | 300 | Phase 1/Phase 2 | NULL |
| 88 | NCT02335281 (ClinicalTrials.gov) | January 2015 | 7/1/2015 | 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 | NULL | Recruiting | 16 Years | 70 Years | Both | 40 | Phase 2 | China |
| 89 | NCT02261636 (ClinicalTrials.gov) | January 2015 | 7/10/2014 | Induction and Maintenance of Remission With Pentasa as Ulcerative Colitis Treatment | Ulcerative Colitis | Drug: mesalazine | Ferring Pharmaceuticals | NULL | Completed | 18 Years | 70 Years | All | 150 | Netherlands | ||
| 90 | NCT02093663 (ClinicalTrials.gov) | December 12, 2014 | 17/3/2014 | 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 | NULL | Completed | 5 Years | 17 Years | All | 107 | Phase 3 | United States;Canada;Hungary;Israel;Poland;Slovakia;United Kingdom;Belgium;Germany;Netherlands |
| 91 | EUCTR2013-001744-65-GB (EUCTR) | 22/10/2014 | 31/03/2014 | A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases | 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] | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 132 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden | ||
| 92 | ChiCTR1800016668 | 2014-10-22 | 2018-06-14 | 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) | NULL | Completed | 18 | 65 | Both | test group:120;Positive control group:120;Combined group:120; | China | |
| 93 | EUCTR2012-003702-27-BE (EUCTR) | 21/10/2014 | 04/02/2014 | 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: 16.1;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 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 762 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Belgium;Poland;Netherlands;Germany;Latvia | ||
| 94 | EUCTR2013-001744-65-PL (EUCTR) | 20/10/2014 | 19/08/2014 | A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases | 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] | Trade Name: Mezavant Gastro-resistant, prolonged release tablets Product Name: Mezavant Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine | Shire Devlopment LLC | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Hungary;Slovakia;Canada;Belgium;Poland;Israel;Netherlands;Germany;United Kingdom;Sweden | ||
| 95 | NCT02280629 (ClinicalTrials.gov) | October 1, 2014 | 29/10/2014 | 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 | NULL | Completed | 18 Years | 70 Years | All | 150 | Phase 3 | Germany |
| 96 | EUCTR2012-003702-27-NL (EUCTR) | 30/09/2014 | 14/04/2014 | 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: 16.1;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 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 762 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Poland;Belgium;Netherlands;Germany;Latvia | ||
| 97 | EUCTR2013-001744-65-HU (EUCTR) | 24/09/2014 | 15/07/2014 | A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases | 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] | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine | Shire Devlopment LLC | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 3 | United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom | ||
| 98 | EUCTR2013-001744-65-SK (EUCTR) | 11/09/2014 | 17/07/2014 | A clinical trial to investigate the safety and effectiveness of MMX Mesalamine/mesalazine in Children and Adolescents aged 5-17 years who have mild to moderate Ulcerative Colitis | A Phase 3, Multicenter, Randomized, Double-blind Study to Determine the Safety and Efficacy of MMX Mesalamine/Mesalazine in Paediatric Subjects with Mild to Moderate Ulcerative Colitis, in both Acute and Maintenance Phases | 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] | Trade Name: Mezavant Gastro-resistant, prolonged release tablets Product Name: Mezavant Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: Mesalazine | Shire Devlopment LLC | NULL | Not Recruiting | Female: yes Male: yes | 132 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Canada;Poland;Belgium;Israel;Netherlands;Germany;United Kingdom;Sweden | ||
| 99 | EUCTR2012-003702-27-PL (EUCTR) | 29/07/2014 | 20/05/2014 | 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: 18.1;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 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 762 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Czech Republic;Hungary;Poland;Belgium;Germany;Latvia;Netherlands | ||
| 100 | NCT02142725 (ClinicalTrials.gov) | July 21, 2014 | 15/5/2014 | Phosphatidylcholine (LT-02) for Induction of Remission in 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 vs. Placebo in Patients With Ulcerative Colitis Refractory to Standard Treatment With Mesalamine | Ulcerative Colitis | Drug: LT-02;Drug: Placebo | Dr. Falk Pharma GmbH | NULL | Terminated | 18 Years | 70 Years | All | 468 | Phase 3 | Germany |
| 101 | EUCTR2013-000366-11-SK (EUCTR) | 19/06/2014 | 21/05/2014 | 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 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Denmark;Bulgaria;Latvia;Sweden | ||
| 102 | EUCTR2012-003702-27-SK (EUCTR) | 10/06/2014 | 06/03/2014 | 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: 19.0;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 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE | Dr. Falk Pharma GmbH | NULL | 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 | ||
| 103 | EUCTR2012-003702-27-LV (EUCTR) | 20/05/2014 | 25/03/2014 | 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: 16.1;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 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 762 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Belgium;Poland;Latvia;Netherlands;Germany | ||
| 104 | EUCTR2012-003702-27-HU (EUCTR) | 19/05/2014 | 07/03/2014 | 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: 18.0;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 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 762 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Russian Federation;Israel;Switzerland;Hungary;Czech Republic;Belgium;Poland;Germany;Latvia;Netherlands | ||
| 105 | EUCTR2012-003702-27-CZ (EUCTR) | 15/05/2014 | 24/02/2014 | 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: 19.0;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 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE | Dr. Falk Pharma GmbH | NULL | 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 | ||
| 106 | EUCTR2012-003702-27-LT (EUCTR) | 12/05/2014 | 19/03/2014 | 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: 16.1;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 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 762 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Poland;Belgium;Netherlands;Germany;Latvia | ||
| 107 | EUCTR2012-003702-27-DE (EUCTR) | 08/05/2014 | 30/12/2013 | 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 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE | Dr. Falk Pharma GmbH | NULL | 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 | ||
| 108 | EUCTR2013-000366-11-BG (EUCTR) | 23/04/2014 | 06/03/2014 | 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: 18.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | 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 | ||
| 109 | EUCTR2012-003702-27-AT (EUCTR) | 02/04/2014 | 10/02/2014 | 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: 16.1;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 INN or Proposed INN: Phosphatidylcholine Other descriptive name: SOYBEAN PHOSPHATIDYLCHOLINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 762 | Phase 3 | Slovakia;Ukraine;Lithuania;Austria;Israel;Russian Federation;Switzerland;Czech Republic;Hungary;Belgium;Poland;Netherlands;Germany;Latvia | ||
| 110 | EUCTR2013-000366-11-LV (EUCTR) | 14/03/2014 | 07/02/2014 | 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: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | 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 | ||
| 111 | EUCTR2013-000366-11-LT (EUCTR) | 10/03/2014 | 22/01/2014 | 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: 17.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | 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 | ||
| 112 | EUCTR2013-000366-11-HU (EUCTR) | 24/02/2014 | 28/11/2013 | 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 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | 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 | ||
| 113 | JPRN-JapicCTI-142475 | 24/12/2013 | 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. | NULL | 16 | BOTH | 250 | Phase 3 | NULL | |||
| 114 | EUCTR2013-000366-11-PL (EUCTR) | 12/12/2013 | 05/09/2013 | 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 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Belarus;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Latvia;Sweden | ||
| 115 | EUCTR2013-000366-11-ES (EUCTR) | 07/10/2013 | 12/07/2013 | 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: 16.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Belarus;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Latvia;Sweden | |||
| 116 | JPRN-UMIN000010127 | 2013/09/24 | 01/04/2013 | Comparative study for mucosal concentration of 5-ASA by once-daily vs divided dosing of oral mesalazine in quiescent ulcerative colitis | Comparative study for mucosal concentration of 5-ASA by once-daily vs divided dosing of oral mesalazine in quiescent ulcerative colitis - Mucosal concentration of 5-ASA by once-daily vs conventional dosing | 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 | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 50 | Not applicable | Japan |
| 117 | EUCTR2013-000366-11-CZ (EUCTR) | 12/09/2013 | 05/06/2013 | 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: 18.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: TP05 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | 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 | ||
| 118 | EUCTR2013-000366-11-BE (EUCTR) | 02/09/2013 | 11/07/2013 | 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 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | 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 | ||
| 119 | NCT01941589 (ClinicalTrials.gov) | September 2013 | 30/8/2013 | 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 | NULL | Completed | 18 Years | N/A | All | 149 | Phase 4 | China;France;Greece;Israel;Italy;Korea, Republic of;Serbia |
| 120 | NCT02306798 (ClinicalTrials.gov) | September 2013 | 15/10/2014 | 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 | NULL | Completed | 18 Years | 55 Years | Both | 9 | Phase 1 | NULL |
| 121 | EUCTR2013-000366-11-GB (EUCTR) | 30/08/2013 | 09/07/2013 | 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 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 800 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belarus;Slovakia;Finland;Spain;Ukraine;Ireland;Lithuania;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Norway;Latvia;Sweden | ||
| 122 | EUCTR2013-000366-11-FI (EUCTR) | 20/08/2013 | 05/07/2013 | 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 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | 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 | ||
| 123 | EUCTR2013-000366-11-IE (EUCTR) | 17/07/2013 | 16/05/2013 | 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 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | 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 | ||
| 124 | EUCTR2013-000366-11-DK (EUCTR) | 10/07/2013 | 10/07/2013 | 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 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | 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 | ||
| 125 | EUCTR2013-000366-11-SE (EUCTR) | 28/06/2013 | 13/05/2013 | 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 INN or Proposed INN: MESALAZINE Trade Name: Asacol INN or Proposed INN: MESALAZINE | Tillotts Pharma AG | NULL | 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 | ||
| 126 | JPRN-UMIN000010906 | 2013/06/10 | 10/06/2013 | The exploratory randomized controlled trial by high-dose Asacol treatment to patients with ulcerative colitis aiming to maintain remission. | The exploratory randomized controlled trial by high-dose Asacol treatment to patients with ulcerative colitis aiming to maintain remission. - Asacol4.8 maintenance | 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 | NULL | Complete: follow-up complete | 15years-old | 70years-old | Male and Female | 60 | Phase 2 | Japan |
| 127 | JPRN-JapicCTI-132135 | 01/5/2013 | 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 | NULL | ||
| 128 | JPRN-UMIN000010340 | 2013/05/01 | 01/04/2013 | Comparison of rectal with oral mesalazine in the treatment of Ulcerative Proctitis (CORRECT Study) | Comparison of rectal with oral mesalazine in the treatment of Ulcerative Proctitis (CORRECT Study) - 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 | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 60 | Not selected | Japan |
| 129 | EUCTR2012-001830-32-LT (EUCTR) | 04/02/2013 | 04/10/2012 | 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 INN or Proposed INN: Mesalazine Trade Name: Salofalk® 500 mg gastro-resistant tablet Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg) Product Code: Mesalazine 500 mg gastro-resistant tablets (Salofa INN or Proposed INN: Mesalazine | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia | ||
| 130 | EUCTR2012-001830-32-PL (EUCTR) | 01/02/2013 | 18/10/2012 | 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: 16.1;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 INN or Proposed INN: Mesalazine Trade Name: Salofalk® 500 mg gastro-resistant tablet Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg) Product Code: Mesalazine 500 mg gastro-resistant tablets (Salofa INN or Proposed INN: Mesalazine | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia | ||
| 131 | EUCTR2012-001830-32-DE (EUCTR) | 15/01/2013 | 14/08/2012 | 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 INN or Proposed INN: Mesalazine Trade Name: Salofalk® 500 mg gastro-resistant tablet Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg) Product Code: Mesalazine 500 mg gastro-resistant tablets (Salofa INN or Proposed INN: Mesalazine | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia;Germany | ||
| 132 | EUCTR2011-000164-10-GB (EUCTR) | 04/01/2013 | 19/09/2012 | 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 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 Code: SPD476 INN or Proposed INN: mesalazine Product Code: SPD476 INN or Proposed INN: mesalazine Trade Name: Mezavant XL 1200mg gastro-resistant, prolonged release tablets Product Code: SPD476 INN or Proposed INN: mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 1 | United States;Slovakia;Poland;Australia;United Kingdom | ||
| 133 | NCT01745770 (ClinicalTrials.gov) | January 2013 | 5/12/2012 | 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 | NULL | Completed | 18 Years | 75 Years | Both | 306 | Phase 3 | Germany |
| 134 | EUCTR2012-004851-35-FI (EUCTR) | 19/12/2012 | 07/12/2012 | Mesalalazine in pediatric ulcerative colitis | Once versus twice daily mesalazine to introduce remission in pediatric ulcerative colitis: a randomized controlled trial | 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: Pentasa Product Name: Pentasa INN or Proposed INN: MESALAZINE Trade Name: Pentasa Product Name: Pentasa INN or Proposed INN: MESALAZINE | Children´s Hospital, University of Helsinki | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Finland;Israel | ||
| 135 | NCT04032652 (ClinicalTrials.gov) | December 2012 | 4/12/2012 | 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 | NULL | Terminated | 18 Years | 45 Years | All | 2 | Phase 2 | NULL |
| 136 | EUCTR2012-001830-32-HU (EUCTR) | 04/10/2012 | 16/08/2012 | 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 INN or Proposed INN: Mesalazine 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 INN or Proposed INN: Mesalazine | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Poland;Ukraine;Lithuania;Russian Federation;Latvia | ||
| 137 | EUCTR2012-001830-32-LV (EUCTR) | 02/10/2012 | 05/09/2012 | 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: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Mesalazine 1000 mg gastro-resistant tablets Product Code: Mesalazine 1000 mg gastro-resistant tablets INN or Proposed INN: Mesalazine Trade Name: Salofalk® 500 mg gastro-resistant tablet Product Name: Mesalazine 500 mg gastro-resistant tablets (Salofalk® 500 mg) Product Code: Mesalazine 500 mg gastro-resistant tablets (Salofa INN or Proposed INN: Mesalazine | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Hungary;Poland;Ukraine;Lithuania;Russian Federation;Germany;Latvia | ||
| 138 | EUCTR2012-002023-15-AT (EUCTR) | 21/09/2012 | 04/09/2012 | Mesacol: The effect of mesalazine on molecular pathways ofcell adhesion in ulcerative colitis | Mesacol: The effect of mesalazine on molecular pathways ofcell 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 INN or Proposed INN: MESALAZINE Other descriptive name: 5-aminosalicylic acid | Medizinische Universität Wien, Universitätsklinik für Innere Medizin 3, Abteilung für Gastroenterologie und Hepatologie | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Austria | ||
| 139 | EUCTR2011-005115-82-LT (EUCTR) | 12/09/2012 | 24/05/2012 | 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: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Hungary;Estonia;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 140 | JPRN-UMIN000008352 | 2012/08/01 | 01/08/2012 | Switch Trial from Several Times to Once Daily Oral Mesalazine Administration in Patients with Quiescent Ulcerative Colitis | Switch Trial from Several Times to Once Daily Oral Mesalazine Administration in Patients with Quiescent Ulcerative Colitis - Once Daily Oral Mesalazine Swich Trial in UC-Patients | Ulcerative Colitis | Switch from several times to once daily oral mesalazine administration | Saitama Medical Center, Saitama Medical University | NULL | Complete: follow-up complete | 15years-old | 70years-old | Male and Female | 50 | Not selected | Japan |
| 141 | NCT01536535 (ClinicalTrials.gov) | July 10, 2012 | 16/2/2012 | 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: Mesalazine;Drug: IV Corticosteroid;Drug: Oral Corticosteroids;Other: Additional Therapies;Procedure: Colectomy | Connecticut Children's Medical Center | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 4 Years | 17 Years | All | 431 | Phase 4 | United States;Canada |
| 142 | EUCTR2011-000164-10-SK (EUCTR) | 21/06/2012 | 13/04/2016 | 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 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: SPD476 Product Code: SPD476 INN or Proposed INN: mesalazine Product Name: SPD476 Product Code: SPD476 INN or Proposed INN: mesalazine Product Name: SPD476 Product Code: SPD476 INN or Proposed INN: mesalazine | Shire Development Inc | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 1 | United States;Slovakia;United Kingdom | ||
| 143 | EUCTR2011-005115-82-LV (EUCTR) | 15/06/2012 | 21/05/2012 | 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® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Hungary;Estonia;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 144 | EUCTR2011-005115-82-EE (EUCTR) | 05/06/2012 | 09/05/2012 | 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® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 500 | United States;Hungary;Czech Republic;Estonia;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 145 | NCT01586533 (ClinicalTrials.gov) | June 2012 | 25/4/2012 | 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. | NULL | Active, not recruiting | 18 Years | 64 Years | Both | 120 | Phase 2 | United States |
| 146 | EUCTR2011-005115-82-BG (EUCTR) | 11/05/2012 | 11/04/2012 | 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: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 147 | EUCTR2011-005115-82-CZ (EUCTR) | 18/04/2012 | 08/02/2012 | 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: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 148 | EUCTR2011-005115-82-PL (EUCTR) | 10/04/2012 | 16/03/2012 | 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: 15.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide-MMX® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Estonia;Hungary;Czech Republic;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 149 | EUCTR2011-005115-82-HU (EUCTR) | 26/03/2012 | 07/02/2012 | 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® INN or Proposed INN: BUDESONIDE | Santarus, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United States;Estonia;Czech Republic;Hungary;Canada;Poland;Ukraine;Lithuania;Bulgaria;Latvia | |||
| 150 | NCT01532648 (ClinicalTrials.gov) | January 27, 2012 | 13/12/2011 | Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA) | 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 | Drug: Budesonide MMX®;Drug: Placebo;Drug: 5-ASA | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | 75 Years | All | 510 | Phase 3 | United States;Bulgaria;Canada;Czechia;Estonia;Hungary;Latvia;Lithuania;Poland;Russian Federation;Ukraine;Czech Republic |
| 151 | NCT02306772 (ClinicalTrials.gov) | December 2011 | 15/10/2014 | 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 | NULL | Completed | 18 Years | 55 Years | Both | 18 | Phase 1 | NULL |
| 152 | NCT01320436 (ClinicalTrials.gov) | July 2011 | 21/3/2011 | 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 | NULL | Completed | 18 Years | 70 Years | Both | 50 | Phase 3 | Israel |
| 153 | JPRN-UMIN000011236 | 2011/05/02 | 20/07/2013 | Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation -Efficacy of on-demand therapy for induction and maintenance of remission - | Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation -Efficacy of on-demand therapy for induction and maintenance of remission - - Evaluation of efficacy of mesalazine suppository in ulcerative colitis with rectal inflammation | 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 | NULL | Complete: follow-up complete | 15years-old | 65years-old | Male and Female | 200 | Not selected | Japan |
| 154 | JPRN-JapicCTI-101380 | 15/11/2010 | 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. | NULL | 16 | BOTH | 228 | Phase 3 | NULL | |||
| 155 | JPRN-JapicCTI-101381 | 15/11/2010 | 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. | NULL | 16 | BOTH | 190 | Phase 3 | NULL | |||
| 156 | EUCTR2010-018557-35-NL (EUCTR) | 08/11/2010 | 11/02/2010 | 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 | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Netherlands | |||
| 157 | EUCTR2009-017044-13-DE (EUCTR) | 03/11/2010 | 16/06/2010 | 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 Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis - MOMENTUM | Ulcerative Colitis MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development Inc | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany | ||
| 158 | NCT01257386 (ClinicalTrials.gov) | November 2010 | 8/12/2010 | 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 | Completed | 18 Years | 64 Years | Both | 251 | Phase 3 | China |
| 159 | NCT01257399 (ClinicalTrials.gov) | November 2010 | 8/12/2010 | 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 | Completed | 18 Years | 64 Years | Both | 251 | Phase 3 | China |
| 160 | NCT01130844 (ClinicalTrials.gov) | October 8, 2010 | 20/5/2010 | 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 | NULL | Completed | 5 Years | 17 Years | All | 52 | Phase 1 | United States;Australia;Poland;Slovakia;United Kingdom |
| 161 | EUCTR2009-017044-13-BE (EUCTR) | 14/09/2010 | 06/05/2010 | 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 Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce 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 | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Belgium;Poland;South Africa;Germany | ||
| 162 | NCT01201122 (ClinicalTrials.gov) | September 2010 | 12/9/2010 | 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 | NULL | Completed | 6 Years | 18 Years | Both | 86 | Phase 4 | Israel |
| 163 | EUCTR2009-017044-13-IE (EUCTR) | 10/08/2010 | 20/04/2010 | A study to Evaluate the Ability to Maintain Clinical andEndoscopic Remission During a 12-Month period with 2.4g/day of druggiven once a day in adults with ulcerative colitis | A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce 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 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany | ||
| 164 | EUCTR2009-017044-13-CZ (EUCTR) | 05/08/2010 | 28/05/2010 | 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 Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce 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 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | Hungary;Canada;Poland;South Africa;Germany;United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Czech Republic | ||
| 165 | EUCTR2009-017044-13-FR (EUCTR) | 27/07/2010 | 22/06/2010 | A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis | A Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis | Ulcerative Colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development Inc | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | France;Czech Republic;Hungary;Belgium;Spain;Ireland;Germany;United Kingdom | ||
| 166 | EUCTR2009-017044-13-HU (EUCTR) | 21/07/2010 | 26/04/2010 | 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 Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce 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 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;South Africa;Germany | ||
| 167 | JPRN-UMIN000003785 | 2010/07/01 | 01/07/2010 | 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. | 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. - A randomized trial of 5-ASA vs. 5-ASA and tacrolimus in maintenance of ulcerative colitis. | 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 | NULL | Complete: follow-up complete | 16years-old | 65years-old | Male and Female | 80 | Phase 3 | Japan |
| 168 | EUCTR2009-017044-13-GB (EUCTR) | 30/06/2010 | 17/03/2010 | 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 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development LLC | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United States;Spain;Ireland;Russian Federation;Colombia;United Kingdom;India;France;Hungary;Czech Republic;Canada;Poland;Belgium;South Africa;Germany | ||
| 169 | NCT01124149 (ClinicalTrials.gov) | June 29, 2010 | 13/5/2010 | Ability to Maintain or Achieve Clinical and Endoscopic Remission With MMX Mesalamine Once Daily in Adults With Ulcerative Colitis | A Phase 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 | Ulcerative Colitis | Drug: MMX mesalamine/ mesalazine | Shire | NULL | Completed | 18 Years | N/A | All | 759 | Phase 4 | United States;Belgium;Canada;Colombia;Czechia;France;Germany;Hungary;India;Ireland;Poland;Romania;South Africa;Spain;United Kingdom;Brazil;Czech Republic |
| 170 | EUCTR2009-017044-13-ES (EUCTR) | 25/06/2010 | 19/04/2010 | Estudio en fase 3b/4, abierto, multicéntrico y prospectivo para evaluar el efecto del estado de la remisión sobre la capacidad para mantener o alcanzar la remisión clínica y endoscópica durante una fase de mantenimiento a largo plazo de 12 meses con 2,4 g/día de MMX mesalamina/mesalazina una vez al día en pacientes adultos con colitis ulcerosaA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis | Estudio en fase 3b/4, abierto, multicéntrico y prospectivo para evaluar el efecto del estado de la remisión sobre la capacidad para mantener o alcanzar la remisión clínica y endoscópica durante una fase de mantenimiento a largo plazo de 12 meses con 2,4 g/día de MMX mesalamina/mesalazina una vez al día en pacientes adultos con colitis ulcerosaA Phase 3b/4, Open-label, Multicenter, Prospective Study to Evaluatethe Effect of Remission Status on the Ability to Maintain or AchieveClinical and Endoscopic Remission During a 12-Month, Long-termMaintenance Phase With 2.4g/day MMX® Mesalamine/mesalazineOnce Daily in Adult Subjects With Ulcerative Colitis | Colitis UlcerosaUlcerative Colitis MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Trade Name: Mezavant XL Gastro-resistant, prolonged release tablets Product Name: Mezavant XL Product Code: SPD476 INN or Proposed INN: MESALAZINE Other descriptive name: MMX Mesalamine/Mesalazine | Shire Development Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | France;Czech Republic;Hungary;Belgium;Spain;Ireland;Germany;United Kingdom | ||
| 171 | NCT01011322 (ClinicalTrials.gov) | December 2009 | 10/11/2009 | A Study to Investigate the Efficacy of LT-02 in Patients With Mesalazine Refractory Ulcerative Colitis | Ulcerative Colitis;Large Intestine;Diarrhea;Abdominal Pain | Drug: LT-02;Drug: placebo | Lipid Therapeutics GmbH | NULL | Active, not recruiting | 18 Years | N/A | Both | 156 | Phase 2 | Germany;Lithuania;Romania | |
| 172 | EUCTR2008-007952-90-LT (EUCTR) | 23/11/2009 | 15/09/2009 | 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. | 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. | 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 INN or Proposed INN: Modified-release phosphatidylcholine Product Name: LT-02 (modified-release PC pellets) Product Code: LT-02 INN or Proposed INN: Modified-release phosphatidylcholine Product Name: LT-02 (modified-release PC pellets) Product Code: LT-02 INN or Proposed INN: Modified-release phosphatidylcholine | Lipid Therapeutics GmbH | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 2 | Germany;Lithuania | ||
| 173 | EUCTR2008-007952-90-DE (EUCTR) | 17/11/2009 | 04/08/2009 | 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 INN or Proposed INN: Modified-release phosphatidylcholine Product Name: LT-02 (modified-release PC pellets) Product Code: LT-02 INN or Proposed INN: Modified-release phosphatidylcholine Product Name: LT-02 (modified-release PC pellets) Product Code: LT-02 INN or Proposed INN: Modified-release phosphatidylcholine | Lipid Therapeutics GmbH | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | Germany;Lithuania | ||
| 174 | NCT00984568 (ClinicalTrials.gov) | November 2009 | 24/9/2009 | Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553) | Conventional Step-Up Versus Infliximab Monotherapy in Patients With Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study | Colitis, Ulcerative | Biological: Infliximab;Drug: Prednisolone;Drug: 5-aminosalicylic acid;Drug: Azathioprine | Merck Sharp & Dohme Corp. | NULL | Terminated | 18 Years | N/A | All | 28 | Phase 3 | Germany |
| 175 | NCT01020708 (ClinicalTrials.gov) | November 2009 | 20/11/2009 | 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. | NULL | Completed | 18 Years | 64 Years | Both | 9 | Phase 1 | United States |
| 176 | EUCTR2009-011608-51-DE (EUCTR) | 09/10/2009 | 21/07/2009 | 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: 15.0;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders | Product Name: GSK1399686 Product Code: GSK1399686 Trade Name: ASACOL Product Name: ASACOL Product Code: ASACOL INN or Proposed INN: mesalazine Other descriptive name: Overencapsulated mesalazine tablets Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686 | GlaxoSmithKline Research and Development Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Germany;Sweden | |||
| 177 | EUCTR2004-004184-29-DK (EUCTR) | 10/09/2009 | 10/10/2007 | 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 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 830 | Phase 3 | Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden | ||
| 178 | EUCTR2009-010921-38-NL (EUCTR) | 08/09/2009 | 02/03/2009 | 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 INN or Proposed INN: mesalazine Trade Name: Ursofalk INN or Proposed INN: ursodeoxycholic acid | UMC Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 179 | EUCTR2009-011608-51-SE (EUCTR) | 17/08/2009 | 22/06/2009 | 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 Trade Name: ASACOL Product Name: ASACOL Product Code: ASACOL INN or Proposed INN: mesalazine Other descriptive name: Overencapsulated mesalazine tablets Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686 | GlaxoSmithKline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 60 | Germany;Sweden | |||
| 180 | EUCTR2009-010065-23-DE (EUCTR) | 17/08/2009 | 14/04/2009 | 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;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders | Trade Name: Remicade INN or Proposed INN: infliximab Other descriptive name: 100 Trade Name: Pentasa 500 mg Retardtabletten Product Name: 5-Aminosalicylic acid (5-ASA) INN or Proposed INN: 5-Aminosalicylic acid Trade Name: Imurek 25mg Filmtabletten INN or Proposed INN: azathioprine Trade Name: Imurek 50mg Filmtabletten INN or Proposed INN: azathioprine Trade Name: Decortin H 1 mg INN or Proposed INN: prednisolone Trade Name: Decortin H 5mg INN or Proposed INN: prednisolone Trade Name: Decortin H 10mg INN or Proposed INN: prednisolone Trade Name: Decortin H 20mg INN or Proposed INN: prednisolone Trade Name: Decortin H 50 mg INN or Proposed INN: prednisolone | Essex Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Germany | |||
| 181 | EUCTR2009-011608-51-BE (EUCTR) | 03/08/2009 | 23/06/2009 | 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 Trade Name: ASACOL Product Name: ASACOL Product Code: ASACOL INN or Proposed INN: mesalazine Other descriptive name: Overencapsulated mesalazine tablets Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686 Product Name: GSK1399686 Product Code: GSK1399686 | GlaxoSmithKline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Belgium;Germany;Sweden | ||
| 182 | EUCTR2008-004610-27-SK (EUCTR) | 06/04/2009 | 09/02/2009 | 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 INN or Proposed INN: dersalazine sodium Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: Mesalazine Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: mesalazine | Palau Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;Slovakia;Spain;Belgium | ||
| 183 | EUCTR2008-007292-25-IT (EUCTR) | 24/03/2009 | 16/03/2009 | 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 INN or Proposed INN: Mesalazine Trade Name: ASACOL INN or Proposed INN: Mesalazine | GIULIANI | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Italy | |||
| 184 | EUCTR2008-000045-59-GB (EUCTR) | 17/03/2009 | 15/07/2008 | 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 active 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%) INN or Proposed INN: MESALAZINE | Ferring Pharmaceuticals Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 398 | United Kingdom;Netherlands;Belgium;France | |||
| 185 | EUCTR2008-004610-27-HU (EUCTR) | 26/02/2009 | 15/12/2008 | 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 INN or Proposed INN: dersalazine sodium Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: Mesalazine Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: mesalazine | Palau Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;Belgium;Spain | ||
| 186 | EUCTR2008-000045-59-BE (EUCTR) | 23/12/2008 | 22/09/2008 | Multicentre, controlled, randomized, investigator-blinded, comparitive study of oral Mesalazine 4 g per day Once daily versus 4 g per day in Two divided doses in patients with Active Ulcerative Colitis. - MOTUS | Multicentre, controlled, randomized, investigator-blinded, comparitive study of oral Mesalazine 4 g per day Once daily versus 4 g per day in Two divided doses in patients with Active Ulcerative Colitis. - MOTUS | Patients with mild to moderate ulcerative colitis | Product Name: Pentasa 2g sachet prolonged release granules (95%) INN or Proposed INN: MESALAZINE | Ferring SAS | NULL | Not Recruiting | Female: yes Male: yes | 398 | Phase 3 | France;Belgium;Netherlands;United Kingdom | ||
| 187 | EUCTR2008-004610-27-BE (EUCTR) | 02/12/2008 | 24/07/2008 | 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 INN or Proposed INN: dersalazine sodium Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: Mesalazine Trade Name: Lixacol Product Name: Lixacol INN or Proposed INN: mesalazine | Palau Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;Belgium;Spain | ||
| 188 | NCT00808977 (ClinicalTrials.gov) | December 2008 | 15/12/2008 | A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative 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 | Ulcerative Colitis | Drug: Dersalazine sodium;Drug: Mesalazine;Drug: Placebo | Palau Pharma S.A. | NULL | Completed | 18 Years | 65 Years | Both | 80 | Phase 2 | Belgium;Hungary;Slovakia;Spain |
| 189 | EUCTR2008-004610-27-ES (EUCTR) | 25/11/2008 | 26/09/2008 | Estudio fase II doble ciego, aleatorizado, controlado con placebo y mesalazina de seguridad y actividad de dersalazina en pacientes con colitis activa leve o moderada.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 | Estudio fase II doble ciego, aleatorizado, controlado con placebo y mesalazina de seguridad y actividad de dersalazina en pacientes con colitis activa leve o moderada.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 | Colitis ulcerosa de leve a moderadaMild to moderate ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis | Product Name: Dersalazina sodica INN or Proposed INN: dersalazine sodium Trade Name: LIXACOL Product Name: LIXACOL INN or Proposed INN: MESALAZINA Other descriptive name: MESALAZINE Trade Name: LIXACOL Product Name: LIXACOL INN or Proposed INN: MESALAZINA Other descriptive name: MESALAZINE | Palau Pharma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Hungary;Slovakia;Belgium;Spain | ||
| 190 | NCT00737789 (ClinicalTrials.gov) | November 2008 | 19/8/2008 | Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active Ulcerative Colitis. | Multicentre, Controlled, Randomised, Investigator-Blinded, Comparative Study of Oral Mesalazine 4g Once Daily Versus Mesalazine 4g in Two Divided Doses in Patients With Active Ulcerative Colitis. | Ulcerative Colitis | Drug: Mesalazine slow-release granules;Drug: Mesalazine liquid enema | Ferring Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 206 | Phase 3 | Belgium;France;Netherlands;United Kingdom |
| 191 | EUCTR2008-000045-59-NL (EUCTR) | 06/10/2008 | 13/08/2008 | 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%) INN or Proposed INN: MESALAZINE | Ferring SAS | NULL | Not Recruiting | Female: yes Male: yes | 398 | United Kingdom;Netherlands;Belgium;France | |||
| 192 | NCT00652145 (ClinicalTrials.gov) | September 2008 | 1/4/2008 | 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 | Completed | 18 Years | N/A | All | 119 | Phase 4 | United States |
| 193 | EUCTR2007-005166-12-DE (EUCTR) | 29/07/2008 | 15/01/2008 | 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 | Product Name: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA (ethanol extract) Product Name: HMPL-004 Other descriptive name: ANDROGRAPHIS PANICULATA (ethanol extract) | Hutchison MediPharma Enterprises Limited | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 2 | Germany | ||
| 194 | EUCTR2008-000045-59-FR (EUCTR) | 04/06/2008 | 22/04/2008 | 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%) INN or Proposed INN: MESALAZINE | Ferring SAS | NULL | Not Recruiting | Female: yes Male: yes | 398 | Phase 3 | France;Belgium;Netherlands;United Kingdom | ||
| 195 | EUCTR2007-007928-18-DE (EUCTR) | 04/06/2008 | 12/11/2008 | 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® INN or Proposed INN: MATRICARIA FLOWER Other descriptive name: MATRICARIA FLOWER INN or Proposed INN: MYRRH Other descriptive name: MYRRH INN or Proposed INN: COFFEE COAL Other descriptive name: COFFEE COAL Trade Name: Salofalk® 500mg INN or Proposed INN: MESALAZINE | REPHA GmbH | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Germany | |||
| 196 | EUCTR2007-004732-23-PL (EUCTR) | 05/05/2008 | 12/05/2008 | A MULTICENTER, RANDOMIZED, 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, 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 10045365;Term: Ulcerative colitis MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative | Product Name: Mesalamine INN or Proposed INN: MESALAZINE Trade Name: Asacol Product Name: Asacol Delayed-Release Tablets INN or Proposed INN: MESALAZINE | EMET Pharmaceuticals, LLC | NULL | Not Recruiting | Female: yes Male: yes | 435 | Estonia;Latvia;Poland | |||
| 197 | EUCTR2007-004732-23-LV (EUCTR) | 27/02/2008 | 28/02/2008 | 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 INN or Proposed INN: MESALAZINE Trade Name: Asacol Product Name: Asacol Delayed-Release Tablets INN or Proposed INN: MESALAZINE | EMET Pharmaceuticals LLC | NULL | Not Recruiting | Female: yes Male: yes | 435 | Estonia;Latvia;Poland | |||
| 198 | NCT00659802 (ClinicalTrials.gov) | February 7, 2008 | 8/4/2008 | 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 low dose;Drug: Placebo;Drug: HMPL-004 high dose | Hutchison Medipharma Limited | NULL | Completed | 18 Years | N/A | All | 224 | Phase 2 | United States |
| 199 | EUCTR2004-004184-29-NL (EUCTR) | 15/01/2008 | 17/10/2007 | 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 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Czech Republic;Hungary;Spain;Denmark;Germany;Netherlands;United Kingdom;Sweden | ||
| 200 | NCT01045018 (ClinicalTrials.gov) | January 2008 | 17/12/2009 | 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. | Completed | 18 Years | N/A | Both | Phase 3 | NULL | |
| 201 | EUCTR2004-004184-29-PT (EUCTR) | 14/12/2007 | 11/10/2007 | 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 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Hungary;Portugal;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden | ||
| 202 | EUCTR2006-005377-22-ES (EUCTR) | 12/12/2007 | 29/10/2007 | Estudio clínico fase III, de doble ciego, doble simulación, aleatorizado, multicéntrico, que compara la eficacia y la tolerancia de 8 semanas de tratamiento oral con 9 mg de budesonida frente a 3 g de mesalazina en pacientes con colitis ulcerosa activa - Budesonida en cápsulas frente a mesalazina en gránulos en la CU activa | Estudio clínico fase III, de doble ciego, doble simulación, aleatorizado, multicéntrico, que compara la eficacia y la tolerancia de 8 semanas de tratamiento oral con 9 mg de budesonida frente a 3 g de mesalazina en pacientes con colitis ulcerosa activa - Budesonida en cápsulas frente a mesalazina en gránulos en la CU activa | Tratamiento de colitis ulcerosa MedDRA version: 9.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis | Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE Trade Name: Salofalk 1000mg Granu-Stix INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Slovakia;Poland;Spain;Lithuania;Latvia;Germany | ||
| 203 | EUCTR2004-004184-29-SE (EUCTR) | 22/11/2007 | 27/09/2007 | 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 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 830 | Phase 3 | Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden | ||
| 204 | EUCTR2006-005377-22-LT (EUCTR) | 13/11/2007 | 14/08/2007 | 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 INN or Proposed INN: BUDESONIDE Trade Name: Salofalk 1000mg Granu-Stix INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Czech Republic;Germany;Spain;Latvia;Poland;Lithuania | ||
| 205 | EUCTR2006-005377-22-DE (EUCTR) | 23/10/2007 | 16/07/2007 | 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 INN or Proposed INN: BUDESONIDE Trade Name: Salofalk 1000mg Granu-Stix INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Czech Republic;Poland;Spain;Lithuania;Latvia;Germany | ||
| 206 | EUCTR2007-004732-23-EE (EUCTR) | 22/10/2007 | 23/10/2007 | 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 INN or Proposed INN: MESALAZINE Trade Name: Asacol Product Name: Asacol Delayed-Release Tablets INN or Proposed INN: MESALAZINE | EMET Pharmaceuticals LLC | NULL | Not Recruiting | Female: yes Male: yes | 435 | Estonia;Latvia;Poland | |||
| 207 | NCT00603733 (ClinicalTrials.gov) | October 2007 | 16/1/2008 | 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 | NULL | Completed | 18 Years | 75 Years | All | 288 | Phase 3 | Canada |
| 208 | NCT00747110 (ClinicalTrials.gov) | October 2007 | 3/9/2008 | Budesonide Capsules Versus Mesalazine Granules 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 9 mg Budesonide or 3 g Mesalazine in Patients With Active Ulcerative Colitis | Colitis, Ulcerative | Drug: budesonide;Drug: mesalazine | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 75 Years | Both | 343 | Phase 3 | Germany |
| 209 | EUCTR2006-005377-22-LV (EUCTR) | 27/09/2007 | 12/09/2007 | 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 INN or Proposed INN: BUDESONIDE Trade Name: Salofalk 1000mg Granu-Stix INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Czech Republic;Germany;Spain;Latvia;Poland;Lithuania | ||
| 210 | EUCTR2006-005377-22-CZ (EUCTR) | 17/09/2007 | 14/09/2007 | 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 INN or Proposed INN: BUDESONIDE Trade Name: Salofalk 1000mg Granu-stix® INN or Proposed INN: MESALAZINE Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Germany;Czech Republic;Spain;Latvia;Poland;Lithuania | ||
| 211 | EUCTR2006-005377-22-SK (EUCTR) | 14/09/2007 | 16/04/2008 | 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 INN or Proposed INN: BUDESONIDE Trade Name: Salofalk 1000mg Granu-Stix® INN or Proposed INN: MESALAZINE Trade Name: Budenofalk 3mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Czech Republic;Slovakia;Poland;Spain;Lithuania;Latvia;Germany | ||
| 212 | NCT00505778 (ClinicalTrials.gov) | July 2007 | 20/7/2007 | 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 | NULL | Completed | 18 Years | N/A | All | 1027 | Phase 3 | United States;Canada;Puerto Rico |
| 213 | NCT00446849 (ClinicalTrials.gov) | May 1, 2007 | 12/3/2007 | 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 | NULL | Completed | 18 Years | N/A | All | 290 | Phase 4 | United States |
| 214 | EUCTR2006-004162-13-DE (EUCTR) | 27/02/2007 | 06/10/2006 | 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 INN or Proposed INN: MESALAZINE | Charité Universitätsmedizin, Campus Charité Mitte | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | Germany | ||
| 215 | EUCTR2006-001782-42-HU (EUCTR) | 20/12/2006 | 16/08/2006 | 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 Other descriptive name: PARNAPARIN SODIUM | Cosmo Technologies Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Hungary;United Kingdom;Italy | |||
| 216 | EUCTR2006-002036-25-GB (EUCTR) | 09/11/2006 | 15/02/2012 | 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 INN or Proposed INN: Epidermal growth factor Trade Name: Pentasa enema Product Name: Pentasa INN or Proposed INN: mesalazine enema | University Hospitals of Leicester NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 3 | United Kingdom | ||
| 217 | EUCTR2006-001782-42-IT (EUCTR) | 03/11/2006 | 20/12/2006 | Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin CB-01-05-MMXTM , 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. - ND | Efficacy and tolerability of a new oral extended-release formulation containing Low Molecular Weight Heparin CB-01-05-MMXTM , 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. - ND | Patients with mild to moderate active ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Product Name: CB-01-05-MMX | COSMO TECHNOLOGIES LTD | NULL | Not Recruiting | Female: yes Male: yes | 120 | Hungary;United Kingdom;Italy | |||
| 218 | EUCTR2006-001782-42-GB (EUCTR) | 17/10/2006 | 29/09/2006 | 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 Other descriptive name: PARNAPARIN SODIUM | Cosmo Technologies Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Italy;United Kingdom | ||
| 219 | ChiCTR-TRC-08000048 | 2006-10-01 | 2008-01-17 | 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 | NULL | Completed | 18 | 65 | Both | Controlled group:112;Experimental group:112; | I (Phase 1 study) | China |
| 220 | NCT00708656 (ClinicalTrials.gov) | October 2006 | 8/4/2008 | The Colitis Once Daily Asacol Study | A Randomized, Single-Blind Study to Assess Efficacy and Safety of Dosing Mesalazine 800 mg Tablets (Asacol®) at 2.4 g Once Daily Versus Divided Doses 3 Times Daily for 12 Months in Maintenance of Remission of Ulcerative Colitis. | Ulcerative Colitis | Drug: mesalazine (Asacol®) | Cardiff and Vale University Health Board | Procter and Gamble | Completed | 18 Years | N/A | All | 213 | Phase 3 | United Kingdom |
| 221 | NCT00343850 (ClinicalTrials.gov) | September 2006 | 21/6/2006 | 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 | Completed | 18 Years | N/A | Both | 30 | Phase 3 | United States |
| 222 | EUCTR2006-001310-32-LT (EUCTR) | 17/07/2006 | 15/05/2006 | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | Ulcerative Colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Product Name: Asacol 800 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) Product Name: Asacol 400 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) | Procter & Gamble Technical Centres Limited | NULL | Not Recruiting | Female: yes Male: yes | 770 | Hungary;Czech Republic;Estonia;Latvia;Lithuania | |||
| 223 | NCT00349388 (ClinicalTrials.gov) | July 2006 | 5/7/2006 | 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 | Terminated | 6 Years | 18 Years | All | 1 | N/A | United States |
| 224 | EUCTR2006-001310-32-HU (EUCTR) | 29/06/2006 | 23/05/2006 | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | Ulcerative Colitis MedDRA version: 8.1;Classification code 10009900 | Product Name: Asacol 800 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) Product Name: Asacol 400 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) | Procter & Gamble Technical Centres Limited | NULL | Not Recruiting | Female: yes Male: yes | 770 | Hungary;Czech Republic;Estonia;Latvia;Lithuania | |||
| 225 | EUCTR2006-001310-32-CZ (EUCTR) | 26/06/2006 | 17/05/2006 | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | Ulcerative Colitis MedDRA version: 8.1;Classification code 10009900 | Product Name: Asacol 800 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) Product Name: Asacol 400 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) | Procter & Gamble Technical Centres Limited | NULL | Not Recruiting | Female: yes Male: yes | 770 | Hungary;Czech Republic;Estonia;Latvia;Lithuania | |||
| 226 | EUCTR2006-001310-32-EE (EUCTR) | 16/06/2006 | 27/04/2006 | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III | Ulcerative Colitis MedDRA version: 8.1;Classification code 10009900 | Product Name: Asacol 800 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) Product Name: Asacol 400 mg tablet INN or Proposed INN: mesalazine Other descriptive name: 5-aminosalicylic acid (5-ASA) | Procter & Gamble Technical Centres Limited | NULL | Not Recruiting | Female: yes Male: yes | 770 | Hungary;Czech Republic;Estonia;Latvia;Lithuania | |||
| 227 | NCT00350415 (ClinicalTrials.gov) | June 2006 | 6/7/2006 | 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 | NULL | Completed | 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 |
| 228 | NCT00408174 (ClinicalTrials.gov) | May 2006 | 4/12/2006 | 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 | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | N/A | All | 400 | Phase 3 | United States |
| 229 | EUCTR2006-001310-32-LV (EUCTR) | 28/04/2006 | 22/08/2006 | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - Ascend III | A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - Ascend III | Ulcerative Colitis | Product Name: Asacol 800mg tablet INN or Proposed INN: mesalazine Product Name: Asacol 400mg tablet INN or Proposed INN: mesalazine | Procter & Gamble Technical Centres Limited | NULL | Not Recruiting | Female: yes Male: yes | 470 | Hungary;Czech Republic;Estonia;Latvia;Lithuania | |||
| 230 | EUCTR2005-002784-91-GB (EUCTR) | 06/02/2006 | 24/11/2005 | 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 INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid | Cardiff and Vale NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 630 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United Kingdom | ||
| 231 | EUCTR2004-001218-15-SI (EUCTR) | 22/12/2005 | 26/10/2005 | 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 | Trade Name: Salofalk® 500mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 750mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 250mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 510 | Estonia;Hungary;Slovenia;Lithuania;Latvia;Germany | |||
| 232 | EUCTR2004-001216-31-SI (EUCTR) | 22/12/2005 | 26/10/2005 | 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® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Estonia;Czech Republic;Hungary;Slovenia;Lithuania;Latvia;Germany | |||
| 233 | NCT00326209 (ClinicalTrials.gov) | December 22, 2005 | 12/5/2006 | Long-Term Safety and Tolerability of Mesalamine Pellets in Participants 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: Encapsulated Mesalamine Granules (eMG) | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | N/A | All | 393 | Phase 3 | United States |
| 234 | NCT00254618 (ClinicalTrials.gov) | October 2005 | 14/11/2005 | 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 | NULL | Terminated | 5 Years | 17 Years | Both | 34 | Phase 1 | United States |
| 235 | EUCTR2004-004565-15-FI (EUCTR) | 26/08/2005 | 28/04/2005 | 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 Product Name: Pentasa INN or Proposed INN: mesalazine Other descriptive name: 5-AminoSalicylic Acid Trade Name: NA Product Name: Pentasa prolonged release granules 2g INN or Proposed INN: mesalazine | Ferring BV | NULL | Not Recruiting | Female: yes Male: yes | 360 | Finland;Germany;Czech Republic;Denmark;Norway;Sweden | |||
| 236 | EUCTR2004-001216-31-CZ (EUCTR) | 17/08/2005 | 17/08/2005 | 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® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Hungary;Germany;Czech Republic;Estonia;Latvia;Lithuania | |||
| 237 | EUCTR2004-001216-31-SK (EUCTR) | 28/07/2005 | 23/05/2005 | 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® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 3 | Estonia;Czech Republic;Hungary;Slovenia;Slovakia;Lithuania;Latvia;Germany | ||
| 238 | EUCTR2004-001216-31-HU (EUCTR) | 28/07/2005 | 20/06/2005 | 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® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania | |||
| 239 | EUCTR2004-001216-31-LV (EUCTR) | 25/07/2005 | 25/07/2005 | 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® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania | |||
| 240 | EUCTR2004-000734-36-CZ (EUCTR) | 13/07/2005 | 08/10/2004 | 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 INN or Proposed INN: Mesalazinum Other descriptive name: 5-amino salicylic acid (5-ASA) | Shire Pharmaceutical Development Inc. | NULL | Not Recruiting | Female: yes Male: yes | 125 | Phase 3 | Czech Republic | ||
| 241 | NCT00449722 (ClinicalTrials.gov) | July 2005 | 20/3/2007 | OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis | 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 | Ulcerative Colitis | Drug: mesalazine | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 75 Years | Both | 380 | Phase 3 | Germany |
| 242 | EUCTR2004-001218-15-EE (EUCTR) | 07/06/2005 | 27/04/2005 | 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 | Trade Name: Salofalk® 500mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 750mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 250mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;Germany;Estonia;Latvia;Lithuania | |||
| 243 | EUCTR2004-001677-26-IT (EUCTR) | 06/06/2005 | 15/02/2006 | Nolpitantium Besylate in patients with mild to moderate Ulcerative Colitis a double-blind, placebo controlled efficacy and safety, 8-week study | Nolpitantium Besylate in patients with mild to moderate Ulcerative Colitis a double-blind, placebo controlled efficacy and safety, 8-week study | Patients with 5-aminosalicylic 5-ASA or sulphasalazine resistant ulcerative colitis MedDRA version: 6.1;Level: PT;Classification code 10009900 | Product Name: Nolpitantium Besylate Product Code: SR140333B | SANOFI-SYNTHELABO | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Czech Republic;Estonia;Spain;Italy;Sweden | |||
| 244 | EUCTR2004-004184-29-DE (EUCTR) | 06/06/2005 | 01/03/2005 | 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 | Product Name: None given Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 410 | Phase 3 | Portugal;Hungary;Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Spain;Sweden | ||
| 245 | EUCTR2004-001216-31-LT (EUCTR) | 06/06/2005 | 28/04/2005 | 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® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania | |||
| 246 | EUCTR2004-004565-15-CZ (EUCTR) | 03/06/2005 | 13/04/2005 | 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 INN or Proposed INN: mesalazine Other descriptive name: 5-AminoSalicylic Acid Product Name: Pentasa prolonged release granules 2g INN or Proposed INN: mesalazine | Ferring BV | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Czech Republic;Finland;Denmark;Germany;Norway;Sweden | ||
| 247 | EUCTR2004-004184-29-GB (EUCTR) | 31/05/2005 | 23/02/2005 | 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 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 826 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Czech Republic;Hungary;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 248 | EUCTR2004-001218-15-LV (EUCTR) | 30/05/2005 | 30/05/2005 | 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 | Trade Name: Salofalk® 500mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 750mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 250mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 510 | Hungary;Germany;Estonia;Latvia;Lithuania | |||
| 249 | EUCTR2004-001216-31-DE (EUCTR) | 30/05/2005 | 04/04/2005 | 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® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania | |||
| 250 | EUCTR2004-004565-15-SE (EUCTR) | 24/05/2005 | 09/03/2005 | 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 Sachet 1 g INN or Proposed INN: mesalazine Other descriptive name: 5-AminoSalicylic Acid Product Name: Pentasa Sachet 2 g INN or Proposed INN: mesalazine | Ferring BV | NULL | Not Recruiting | Female: yes Male: yes | 360 | Finland;Germany;Czech Republic;Denmark;Norway;Sweden | |||
| 251 | EUCTR2004-004184-29-ES (EUCTR) | 05/05/2005 | 03/04/2006 | 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. | 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. | Ulcerative colitis MedDRA version: 3.2;Level: LLT;Classification code 10045365 | Product Code: SPD476 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 410 | Phase 3 | Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden | ||
| 252 | NCT00746447 (ClinicalTrials.gov) | May 2005 | 3/9/2008 | Once Daily (OD) Versus Three Times Daily (TID) Dosing With Mesalazine Granules for Prevention of Recurrence of Ulcerative Colitis (UC) | Double-blind, Double-dummy, Randomised, Multicentre, 12-months, Comparative Study of the Efficacy and Tolerability of Once Daily 3.0 g Mesalazine Granules vs. Once Daily 1.5 g Mesalazine Granules vs. Three Times Daily 0.5 g Mesalazine Granules for Maintenance of Remission in Patients With Ulcerative Colitis | Colitis, Ulcerative;Recurrence | Drug: mesalamine granules | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 75 Years | Both | 648 | Phase 3 | Germany |
| 253 | EUCTR2004-004077-29-SK (EUCTR) | 25/04/2005 | 01/02/2005 | 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 INN or Proposed INN: Delmitide acetate Other descriptive name: SF257 C59 Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid | Procter & Gamble Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 2 | Czech Republic;Slovakia;Lithuania;Germany;United Kingdom | ||
| 254 | EUCTR2004-004184-29-CZ (EUCTR) | 13/04/2005 | 11/04/2005 | 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 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Hungary;Germany;United Kingdom;Czech Republic;Netherlands;Denmark;Spain;Sweden | ||
| 255 | NCT00151892 (ClinicalTrials.gov) | April 8, 2005 | 7/9/2005 | Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis | A Phase III, Randomized Multi-centre, Double-blind, Parallel Group, Active Comparator Study to Compare the Efficacy and Safety of SPD476 (Mesalazine)2.4g/Day Once Daily With Asacol 1.6g/Day Twice Daily in the Maintenance of Remission in Patients With Ulcerative Colitis | Ulcerative Colitis | Drug: SPD476;Drug: Asacol | Shire | NULL | Completed | 18 Years | N/A | All | 829 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;Chile;Czechia;Denmark;France;Germany;Hungary;India;Korea, Republic of;Mexico;Netherlands;New Zealand;Peru;Poland;Portugal;Romania;Russian Federation;Singapore;South Africa;Spain;Sweden;Taiwan;United Kingdom;Czech Republic |
| 256 | EUCTR2004-004565-15-NO (EUCTR) | 06/04/2005 | 14/02/2005 | 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 INN or Proposed INN: mesalazine Other descriptive name: 5-AminoSalicylic Acid Trade Name: NA Product Name: Pentasa prolonged release granules 2g INN or Proposed INN: mesalazine | Ferring BV | NULL | Not Recruiting | Female: yes Male: yes | 360 | Finland;Germany;Czech Republic;Denmark;Norway;Sweden | |||
| 257 | EUCTR2004-001218-15-DE (EUCTR) | 04/04/2005 | 10/12/2004 | 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 | INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 750mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 250mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 510 | Hungary;Germany;Estonia;Latvia;Lithuania | |||
| 258 | EUCTR2004-004565-15-DK (EUCTR) | 31/03/2005 | 24/02/2005 | 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 | Product Name: Pentasa Sachet INN or Proposed INN: mesalazine Other descriptive name: 5-AminoSalicylic Acid Product Name: Pentasa Sachet INN or Proposed INN: mesalazine | Ferring BV | NULL | Not Recruiting | Female: yes Male: yes | 360 | Finland;Germany;Czech Republic;Denmark;Norway;Sweden | |||
| 259 | EUCTR2004-004184-29-HU (EUCTR) | 30/03/2005 | 10/02/2005 | 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 INN or Proposed INN: Mesalazine Other descriptive name: 5-amino salicylic acid Trade Name: Asacol Delayed Release Tablets Product Name: Asacol INN or Proposed INN: Mesalazine Other descriptive name: 5-aminosalicylic acid | Shire Pharmaceutical Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 826 | Phase 3 | Portugal;Czech Republic;Hungary;Spain;Denmark;Netherlands;Germany;United Kingdom;Sweden | ||
| 260 | EUCTR2004-001218-15-SK (EUCTR) | 24/03/2005 | 02/02/2005 | 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 | Trade Name: Salofalk® 500mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 750mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 250mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Estonia;Hungary;Slovenia;Slovakia;Lithuania;Latvia;Germany | ||
| 261 | EUCTR2004-001677-26-EE (EUCTR) | 23/03/2005 | 23/03/2005 | 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 INN or Proposed INN: Nolpitantium besylate | Sanofi-Synthelabo Recherche | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Czech Republic;Estonia;Spain;Italy;Sweden | |||
| 262 | EUCTR2004-001218-15-HU (EUCTR) | 17/03/2005 | 04/02/2005 | 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 | Trade Name: Salofalk® 500mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 750mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 250mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 510 | Hungary;Germany;Estonia;Latvia;Lithuania | |||
| 263 | EUCTR2004-004077-29-GB (EUCTR) | 18/02/2005 | 23/02/2005 | 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 | 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 | 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 INN or Proposed INN: Delmitide acetate Other descriptive name: SF257 C59 Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid | Procter & Gamble Technical Centres Ltd | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Lithuania;Germany;United Kingdom | |||
| 264 | EUCTR2004-001218-15-LT (EUCTR) | 09/02/2005 | 27/12/2004 | 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 | Trade Name: Salofalk® 500mg Granu-Stix® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 750mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 250mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;Germany;Estonia;Latvia;Lithuania | |||
| 265 | EUCTR2004-004077-29-LT (EUCTR) | 09/02/2005 | 22/12/2004 | 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 INN or Proposed INN: Delmitide acetate Other descriptive name: SF257 C59 Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid | Procter & Gamble Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 250 | United Kingdom;Czech Republic;Germany;Lithuania | |||
| 266 | EUCTR2004-001677-26-SE (EUCTR) | 07/02/2005 | 23/12/2004 | 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 INN or Proposed INN: Nolpitantium besylate | Sanofi-Synthelabo Recherche | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Czech Republic;Estonia;Spain;Italy;Sweden | |||
| 267 | EUCTR2004-004077-29-DE (EUCTR) | 04/02/2005 | 22/12/2004 | 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 INN or Proposed INN: Delmitide acetate Other descriptive name: SF257 C59 Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid | Procter & Gamble Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 250 | United Kingdom;Czech Republic;Germany;Lithuania | |||
| 268 | EUCTR2004-004077-29-CZ (EUCTR) | 03/02/2005 | 03/02/2005 | 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 INN or Proposed INN: Delmitide acetate Other descriptive name: SF257 C59 Product Name: mesalazine INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic Acid | Procter & Gamble Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 250 | United Kingdom;Germany;Czech Republic;Lithuania | |||
| 269 | EUCTR2004-001677-26-HU (EUCTR) | 25/01/2005 | 03/11/2004 | 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 INN or Proposed INN: Nolpitantium besylate | Sanofi-Synthelabo Recherche | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Estonia;Czech Republic;Hungary;Spain;Italy;Sweden | ||
| 270 | EUCTR2004-001677-26-ES (EUCTR) | 14/01/2005 | 01/06/2005 | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study.Estudio doble ciego, controlado con placebo de 8 semanas de duración, de eficacia y seguridad de besilato de nolpitantium en pacientes con colitis ulcerosa leve a moderada. - NICE | Nolpitantium Besylate In patients with mild to moderate Ulcerative Colitis: a double-blind, placebo-controlled Efficacy and safety, 8-week study.Estudio doble ciego, controlado con placebo de 8 semanas de duración, de eficacia y seguridad de besilato de nolpitantium en pacientes con colitis ulcerosa leve a moderada. - 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 INN or Proposed INN: Nolpitantium besylate | Sanofi-Synthelabo Recherche | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | Estonia;Czech Republic;Hungary;Spain;Italy;Sweden | ||
| 271 | EUCTR2004-001216-31-EE (EUCTR) | 11/01/2005 | 20/09/2005 | 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® INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 1500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid Product Name: 500mg mesalazine pellets INN or Proposed INN: Mesalazine Other descriptive name: 5-Aminosalicylic acid | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 320 | Hungary;Czech Republic;Germany;Estonia;Latvia;Lithuania | |||
| 272 | NCT00767728 (ClinicalTrials.gov) | December 2004 | 17/9/2008 | 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 | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | N/A | All | 256 | Phase 3 | United States |
| 273 | NCT00744016 (ClinicalTrials.gov) | December 2004 | 27/8/2008 | 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 | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | N/A | All | 305 | Phase 3 | United States |
| 274 | EUCTR2004-000611-25-IE (EUCTR) | 19/10/2004 | 16/08/2004 | 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 Other descriptive name: 6-[2-(3,4-diethoxyphenyl)thiazol-4-yl] pyridine-2-carboxylic acid Trade Name: Asacol (mesalamine) Delayed-release Tablets Product Name: Asacol INN or Proposed INN: Mesalamine Other descriptive name: 5-amino-2-hydroxybenzoic acid | Otsuka Maryland Research Institute, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1725 | Phase 3 | Hungary;Ireland | ||
| 275 | EUCTR2004-000611-25-HU (EUCTR) | 15/10/2004 | 21/07/2004 | 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 Other descriptive name: 6-[2-(3,4-diethoxyphenyl)thiazol-4-yl] pyridine-2-carboxylic acid Trade Name: Asacol (mesalamine) Delayed-release Tablets Product Name: Asacol INN or Proposed INN: Mesalamine Other descriptive name: 5-amino-2-hydroxybenzoic acid | Otsuka Maryland Research Institute, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1725 | Phase 3 | Hungary;Ireland | ||
| 276 | EUCTR2004-000916-25-IT (EUCTR) | 28/09/2004 | 18/05/2005 | 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 INN or Proposed INN: Mesalazine | GIULIANI | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Italy | |||
| 277 | EUCTR2004-000733-12-CZ (EUCTR) | 14/07/2004 | 01/07/2004 | 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 INN or Proposed INN: Mesalazinum Other descriptive name: 5-amino salicylic acid (5-ASA) | Shire Pharmaceutical Development Inc | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | Czech Republic | ||
| 278 | EUCTR2004-001677-26-CZ (EUCTR) | 09/03/2004 | 10/02/2005 | 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 INN or Proposed INN: Nolpitantium besylate | sanofi-aventis recherche & developpement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Czech Republic;Estonia;Spain;Italy;Sweden | |||
| 279 | NCT00548574 (ClinicalTrials.gov) | December 4, 2003 | 23/10/2007 | 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 | NULL | Completed | 18 Years | N/A | All | 343 | Phase 3 | Belgium |
| 280 | NCT00151944 (ClinicalTrials.gov) | November 26, 2003 | 7/9/2005 | Safety and Tolerability of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis. | A Phase III, Randomized, Multi-center, Open-label, 12 to 14 Month Extension Study to Evaluate the Safety and Tolerability of SPD476 (Mesalazine) Given Once Daily vs. Twice Daily for the Maintenance of Ulcerative Colitis in Remission. | Colitis, Ulcerative | Drug: SPD476 (mesalazine) | Shire | NULL | Completed | 18 Years | N/A | All | 400 | Phase 3 | NULL |
| 281 | NCT00503243 (ClinicalTrials.gov) | September 30, 2003 | 16/7/2007 | Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis | A Phase III, Randomized, Multi-Centre, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) Versus SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative Colitis | Colitis, Ulcerative | Drug: Delayed and extended release mesalazine | Shire | NULL | Completed | 18 Years | N/A | All | 280 | Phase 3 | United States |
| 282 | NCT00194818 (ClinicalTrials.gov) | June 2003 | 15/9/2005 | 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 | Completed | 18 Years | 80 Years | Both | 7 | Phase 4 | United States |
| 283 | NCT00545389 (ClinicalTrials.gov) | February 10, 2003 | 16/10/2007 | 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 | NULL | Completed | 18 Years | N/A | All | 38 | Phase 2 | Belgium |
| 284 | NCT00577473 (ClinicalTrials.gov) | February 2001 | 19/12/2007 | 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 | NULL | Completed | 18 Years | 65 Years | All | 301 | Phase 3 | United States |
| 285 | NCT00073021 (ClinicalTrials.gov) | September 2000 | 13/11/2003 | 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 | NULL | Completed | 18 Years | 75 Years | All | 386 | Phase 3 | United States;Canada;Puerto Rico |
| 286 | EUCTR2007-005702-49-PL (EUCTR) | 17/06/2009 | A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy ofAsacol® (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 ofAsacol® (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 INN or Proposed INN: MESALAZINE | Procter & Gamble Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Poland | |||
| 287 | JPRN-JapicCTI-090967 | 09/12/2009 | 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 | NULL | 15 | 64 | BOTH | Phase 3 | NULL | |||
| 288 | EUCTR2006-005377-22-PL (EUCTR) | 14/02/2008 | 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 INN or Proposed INN: BUDESONIDE Trade Name: Salofalk 1000mg Granu-Stix INN or Proposed INN: MESALAZINE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Slovakia;Spain;Poland;Lithuania;Latvia;Germany | |||
| 289 | EUCTR2004-004565-15-DE (EUCTR) | 15/09/2005 | 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 | Product Name: Pentasa INN or Proposed INN: mesalazine Other descriptive name: 5-AminoSalicylic Acid Product Name: Pentasa prolonged release granules 2g INN or Proposed INN: mesalazine | Ferring BV | NULL | Not Recruiting | Female: yes Male: yes | 360 | Finland;Czech Republic;Germany;Denmark;Norway;Sweden | ||||
| 290 | JPRN-JapicCTI-121943 | 30/08/2012 | 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 | NULL | |||||
| 291 | JPRN-JapicCTI-111421 | PS-SP PhaseIII Clinical Study; Investigation to find new formulation of mesalazine for treatment of patients with active Ulcerative Colitis. | PS-SP PhaseIII Clinical Study; Investigation to find new formulation of mesalazine for treatment of patients with active Ulcerative Colitis. | Ulcerative Colitis | Intervention name : PS-SP Dosage And administration of the intervention : PS-SP suppository 1g or placebo is administered rectally once a day. Control intervention name : null | Kyorin Pharmaceutical Co.,LTD | NULL | 15 | 74 | BOTH | Phase 3 | NULL | ||||
| 292 | JPRN-JapicCTI-101144 | 25/05/2010 | 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. | NULL | 16 | 64 | BOTH | Phase 2-3 | NULL |