Asacol® (DrugBank: -)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 97 | Ulcerative colitis | 24 |
| 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 | 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 | ||
| 2 | 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 |
| 3 | 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 |
| 4 | NCT01004185 (ClinicalTrials.gov) | October 2009 | 27/10/2009 | Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis | A Randomized, Double-blind, Parallel-group Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8g/Day) 400 mg Delayed-release Tablets Given Twice Daily for 26 Weeks to Children and Adolescents for the Maintenance of Remission of Ulcerative Colitis | Ulcerative Colitis | Drug: Asacol 400 mg | Warner Chilcott | NULL | Terminated | 5 Years | 17 Years | All | 39 | Phase 3 | United States;Canada;Croatia;Poland;Romania;Russian Federation |
| 5 | 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 | ||
| 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 |
| 6 | NCT00713310 (ClinicalTrials.gov) | December 2008 | 9/7/2008 | Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis | Study to Assess the Safety and Efficacy of Asacol® (1.2 to 4.8 g/Day) Administered as 400 mg Delayed-release Tablets Given Every 12 Hours for 6 Weeks to Children and Adolescents With Mildly-to-Moderately Active Ulcerative Colitis | Ulcerative Colitis | Drug: Asacol 400 mg | Warner Chilcott | NULL | Completed | 5 Years | 17 Years | All | 83 | Phase 3 | United States;Canada;Croatia;Poland;Romania |
| 7 | NCT00679432 (ClinicalTrials.gov) | June 2008 | 14/5/2008 | (CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis | Efficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol® 2400 mg. | Ulcerative Colitis | Procedure: Blood sampling, endoscopy;Drug: budesonide-MMX® 6 mg;Drug: budesonide-MMX® 9 mg;Drug: Placebo;Drug: Asacol® 400 mg | Bausch Health Americas, Inc. | NULL | Completed | 18 Years | 75 Years | All | 510 | Phase 3 | United States;Canada;India;Mexico |
| 8 | 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 | |||
| 9 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 826 | Phase 3 | Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden | ||
| 10 | 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 | |
| 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 |
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 |
| 14 | 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 |
| 15 | 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 |
| 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 |
| 16 | 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. | Cardiff and Vale NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 630 | Phase 3 | United Kingdom | |||
| 17 | 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 | ||
| 18 | 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 | 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 | |||
| 19 | 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 | ||
| 20 | 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 | ||
| 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 |
| 21 | 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 | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 826 | Phase 3 | Portugal;Hungary;Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Spain;Sweden | ||
| 22 | 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 | ||
| 23 | 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 | ||
| 24 | NCT00092508 (ClinicalTrials.gov) | May 2004 | 22/9/2004 | CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission | Phase 3, Multi-Center, Randomized, Double-Blind, Parallel-Arm, 52-Week Dose Comparison Study of the Efficacy and Safety of 25 mg QD and 50 mg QD of OPC-6335 Oral Tablets and 800 mg BID of Asacol® in the Maintenance of Ulcerative Colitis Remission | Ulcerative Colitis | Drug: OPC-6535;Drug: Asacol® | Otsuka Pharmaceutical Development & Commercialization, Inc. | NULL | Completed | 18 Years | 80 Years | Both | 1725 | Phase 3 | United States |