Asacol (mesalamine) delayed-release tablets (DrugBank: Mesalamine)
1 disease| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 97 | Ulcerative colitis | 2 |
| 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 | 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 | ||
| 2 | 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 |