Conditions: Ulcerative Colitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 301
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet

Detailed description:
This study is designed to evaluate the safety and efficacy of 4.8 g/day using 800 mg Asacol tablets as compared to 2.4g/day using 400 mg Asacol tablets in newly- and previously-diagnosed patients who are experiencing a flare-up of mildly to moderately active ulcerative colitis.

Arms:
arm 1: mesalamine 2.4 g/day (400 mg tablet) for 6 weeks arm 2: mesalamine 4.8 g/day (800 mg tablet) for 6 weeks

Interventions: intervention 1: mesalamine intervention 2: mesalamine
Intervention descriptions: intervention 1: mesalamine 2.4 g/day (400 mg tablet) for 6 weeks intervention 2: mesalamine 4.8 g/day (800 mg tablet) for 6 weeks

Protocol document: