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 | NCT04499495 (ClinicalTrials.gov) | October 25, 2021 | 31/7/2020 | Assessment of 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in Korea | A Retrospective Study to Assess 5-Aminosalicylic Acid Prescription Patterns and Treatment Outcomes in Patients With Ulcerative Colitis in Korea | Ulcerative Colitis | Other: PENTASA (mesalamine/ 5-Aminosalicylic acid (5-ASA) | Ferring Pharmaceuticals | NULL | Recruiting | 15 Years | N/A | All | 15000 | Korea, Republic of | |
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | |
| 11 | 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 |
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | NCT01517607 (ClinicalTrials.gov) | February 2012 | 20/1/2012 | Mesalazine (PENTASA®) in Ulcerative Colitis | Mesalazine (PENTASA®) in Ulcerative Colitis: Correlation of the Information Level With Patient's Compliance in Everyday Practice | Ulcerative Colitis | Other: Mesalazine | Ferring Pharmaceuticals | Ferring Arzneimittel GmbH | Completed | 18 Years | N/A | Both | 506 | N/A | Germany |
| 15 | 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 |
| 16 | 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 | |||
| 17 | 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 | |||
| 18 | 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 | ||
| 19 | 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 | |||
| 20 | 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 | ||
| 21 | 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 |
| 22 | 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 | ||
| 23 | JPRN-C000000288 | 2005/12/01 | 21/11/2005 | Z-206 Phase III Clinical Trial- Investigation on the remission-inducing effect in patients with ulcerative colitis in active phase - | Patients with ulcerative colitis in active phase | Z-206 2.4g/day dose group: Two Z-206 400mg tablets, 1 tablet of Z-206 placebo tablet, 3 tablets of Pentasa placebo tablet per time (total 6 tablets). 3 times a day (t.i.d.) after each meal for 8 weeks. Z-206 3.6g/day dose group: Three tablets of Z-206 400mg tablet, 3 tablets of Pentasa placebo tablet per time (total 6 tablets). 3 times a day (t.i.d.) after each meal for 8 weeks. Mesalazine group: Three tablets of Pentasa 250 mg tablet and 3 tablets of Z-206 placebo tablet per time (total 6 tablets). 3 times a day (t.i.d.) after each meal for 8 weeks. Placebo group: Three tablets of Z-206 placebo tablet and 3 tablets of Pentasa placebo tablet per time (total 6 tablets). 3 times a day (t.i.d.) after each meal for 8 weeks. | Zeria Pharmaceutical Co.,LTD. | NULL | Complete: follow-up complete | 16years-old | 64years-old | Male and Female | 210 | Phase 3 | Japan | |
| 24 | JPRN-C000000289 | 2005/12/01 | 21/11/2005 | Z-206 Phase III Clinical Trial- Investigation on the remission-maintaining effect in patients with ulcerative colitis in remission phase - | Patients with ulcerative colitis in remission phase. | Z-206 group : Two Z-206 400 mg tablets, 3 tablets of Pentasa placebo tablet per time (total 5 tablets). 3 times a day (t.i.d.) after each meal for 48 weeks. Mesalazine group: Three tablets of Pentasa 250 mg tablet and 2 tablets of Z-206 placebo tablet per time (total 5 tablets). 3 times a day (t.i.d.) after each meal for 48 weeks. | Zeria Pharmaceutical Co.,LTD. | NULL | Complete: follow-up complete | 16years-old | 64years-old | Male and Female | 120 | Phase 3 | Japan | |
| 25 | EUCTR2005-000695-40-GB (EUCTR) | 27/09/2005 | 17/08/2005 | A randomised trial of aminosalicylate withdrawal in patients with ulcerative colitis in established remission on combination treatment of azathioprine (or 6-mercaptopurine) and an aminosalicylate - CASA trial | A randomised trial of aminosalicylate withdrawal in patients with ulcerative colitis in established remission on combination treatment of azathioprine (or 6-mercaptopurine) and an aminosalicylate - CASA trial | The medical condition is Ulcerative Colitis. | Product Name: products containing azathioprine or 6-mercaptopurine INN or Proposed INN: azathioprine INN or Proposed INN: azathioprine INN or Proposed INN: 6-mercaptopurine Product Name: Products containing aminosalicylate INN or Proposed INN: Sulphsalazine, Pentasa, Asacol, Colazide, Depentum | University of Nottingham | NULL | Not Recruiting | Female: yes Male: yes | 420 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 26 | 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 | |||
| 27 | NCT00167882 (ClinicalTrials.gov) | July 2005 | 9/9/2005 | The Influence of 5–Aminosalicylates on Thiopurine Metabolite Levels | Crohn's Disease;Ulcerative Colitis;Inflammatory Bowel Disease | Drug: 5-aminosalicylate (Pentasa, Ferring) | VU University Medical Center | NULL | Completed | 18 Years | 70 Years | Both | 24 | Phase 4 | Netherlands | |
| 28 | 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 | ||
| 29 | 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 | |||
| 30 | NCT00209300 (ClinicalTrials.gov) | May 2005 | 13/9/2005 | Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission | Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission. A European Multi-centre Investigator Blinded Randomized Controlled Study of Pentasa Sachet Comparing One Gram Twice With Two Grams Once Daily | Ulcerative Colitis | Drug: Pentasa | Ferring Pharmaceuticals | NULL | Completed | 18 Years | N/A | Both | 362 | Phase 3 | Belgium;Czech Republic;Denmark;Finland;Germany;Netherlands;Norway;Sweden |
| 31 | 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 | |||
| 32 | 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 | |||
| 33 | 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 |