97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details
臨床試験数 : 2,527 / 薬物数 : 1,465 - (DrugBank : 259) / 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 | JPRN-UMIN000030000 | 2018/02/07 | 01/12/2017 | The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis. | The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis. - The efficacy and safety of topical budezonide for pouchitis. | ulcerative colitispouchitis | Topical budesonido 2weeks of 2mg daily Topical prednisolone 2weeks 20mg daily Topical aminosalicylate 2weeks 1g daily | Department of Inflammatory Bowel DiseaseHyogo College of Medicine | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 30 | Phase 1 | Japan |
| 2 | NCT02425852 (ClinicalTrials.gov) | December 2016 | 21/4/2015 | A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis | A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus Infliximab to Corticosteroids Plus Azathioprine for Acute Severe Colitis | Ulcerative Colitis | Drug: Azathioprine;Drug: Infliximab;Drug: Prednisolone;Drug: Hydrocortisone | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | NULL | Recruiting | 18 Years | N/A | All | 146 | Phase 4 | France |
| 3 | EUCTR2010-020448-37-NL (EUCTR) | 21/12/2011 | 16/09/2010 | Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis. | Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis. | Active Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PEG-liposomal prednisolone sodium phosphate Product Code: Nanocort INN or Proposed INN: Prednisolone Sodium Phosphate Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE | Enceladus Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Belgium;Netherlands | ||
| 4 | JPRN-UMIN000005358 | 2011/04/01 | 01/04/2011 | Rapid LeukocyAPheresis InDuction for Ulcerative Colitis | ulcerative colitis | LCAP is determined to apply if patient does not obtain a significant improvement (higher than 50%) in spite of recieving sufficient steroid therapy (higher than 30mg/day of prednisolone) for 3 days. LCAP is determined to apply if patient does not obtain a significant improvement (higher than 50%) in spite of recieving sufficient steroid therapy (higher than 30mg/day of prednisolone) for 14 days. | Lower Gastroenterology, Hyogo College of Medicine | Department of Gastroenterology, Osaka City University and Department of Gastroenterology, Osaka Medical College | Complete: follow-up complete | 12years-old | 81years-old | Male and Female | 40 | Phase 2,3 | Japan | |
| 5 | EUCTR2010-020448-37-BE (EUCTR) | 10/12/2010 | 22/12/2010 | Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis. | Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis. | Active Ulcerative Colitis MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: PEG-liposomal prednisolone sodium phosphate Product Code: Nanocort INN or Proposed INN: Prednisolone Sodium Phosphate Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE | Enceladus Pharmaceuticals | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Belgium;Netherlands | ||
| 6 | EUCTR2008-005903-25-BG (EUCTR) | 23/04/2010 | 14/04/2010 | Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis) | Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis) | inflammatory bowel disease (Crohn’s disease and ulcerative colitis) MedDRA version: 12.0;Level: LLT;Classification code 10021973;Term: Inflammatory bowel disease NOS | Product Name: SC12267 Product Code: SC12267 Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon | 4SC AG | NULL | Not Recruiting | Female: yes Male: yes | 24 | Germany;Bulgaria | |||
| 7 | 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 |
| 8 | 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 | |||
| 9 | EUCTR2008-005903-25-DE (EUCTR) | 08/01/2009 | 03/11/2008 | Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis) | Exploratory, open-label study to demonstrate efficacy, safety and tolerability of SC12267 (35 mg) in patients with inflammatory bowel disease (Crohn’s disease and ulcerative colitis) | inflammatory bowel disease (Crohn’s disease and ulcerative colitis) MedDRA version: 12.0;Level: LLT;Classification code 10021973;Term: Inflammatory bowel disease NOS | Product Name: SC12267 Product Code: SC12267 Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon Trade Name: Prednisolon Jenapharm INN or Proposed INN: Prednisolon | 4SC AG | NULL | Not Recruiting | Female: yes Male: yes | 35 | Bulgaria;Germany | |||
| 10 | EUCTR2004-005032-35-BE (EUCTR) | 06/03/2007 | 23/11/2006 | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | Moderate acute ulcerative colitis. | Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate | Alizyme Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 890 | Hungary;Czech Republic;United Kingdom;Denmark;Belgium;Spain;Italy;Sweden | |||
| 11 | EUCTR2004-005032-35-IT (EUCTR) | 10/05/2006 | 19/01/2007 | A Phase III, Multicentre, Pan-European, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of Targeted Release Prednisolone in Treatment of Moderate, Acute Ulcerative Colitis | A Phase III, Multicentre, Pan-European, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of Targeted Release Prednisolone in Treatment of Moderate, Acute Ulcerative Colitis | Ulcerative colitis MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative | Product Name: COLAL PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone Product Name: COLAL PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone Product Name: COLAL PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone Trade Name: PREDNISOLONE INN or Proposed INN: Prednisolone | ALIZYME | NULL | Not Recruiting | Female: yes Male: yes | 890 | Phase 3 | Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden | ||
| 12 | NCT00299013 (ClinicalTrials.gov) | March 2006 | 2/3/2006 | Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis | A Multicentre, Randomised, Double Blind, Double Dummy, Active Comparator Controlled, Parallel Group Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative Colitis | Ulcerative Colitis | Drug: COLAL-PRED®;Drug: Prednisolone | Alizyme | NULL | Completed | 18 Years | 75 Years | Both | 796 | Phase 3 | Australia;Belgium;Czech Republic;Denmark;France;Germany;Hungary;Israel;Italy;Poland;Russian Federation;South Africa;Spain;Sweden;United Kingdom |
| 13 | EUCTR2004-005032-35-SE (EUCTR) | 17/11/2005 | 14/09/2005 | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | Moderate acute ulcerative colitis. | Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate | Alizyme Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 890 | Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden | |||
| 14 | EUCTR2004-005032-35-CZ (EUCTR) | 04/11/2005 | 16/09/2005 | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | Moderate acute ulcerative colitis. | Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate | Alizyme Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 890 | Hungary;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Italy;Sweden | |||
| 15 | EUCTR2004-005032-35-HU (EUCTR) | 24/10/2005 | 22/09/2005 | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | Moderate acute ulcerative colitis. | Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Trade Name: Prednisolone Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate | Alizyme Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 890 | Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden | |||
| 16 | EUCTR2004-005032-35-DK (EUCTR) | 24/10/2005 | 04/10/2005 | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | Moderate acute ulcerative colitis. | Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate | Alizyme Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 890 | Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden | |||
| 17 | EUCTR2004-005032-35-GB (EUCTR) | 11/10/2005 | 24/02/2005 | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. | Moderate acute ulcerative colitis. | Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Trade Name: Prednisolone Tablets B.P. 5mg Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate Product Name: COLAL-PRED Product Code: ATL-2502 INN or Proposed INN: Prednisolone sodium metasulphobenzoate | Alizyme Therapeutics Limited | NULL | Not Recruiting | Female: yes Male: yes | 890 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Czech Republic;Belgium;Spain;Denmark;Italy;United Kingdom;Sweden |