Conditions: Ulcerative Colitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 829
Healthy volunteers: no

Brief summary:
Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis. Mesalazine is an experimental drug designed to gradually release 5-ASA into the areas of large bowel associated with ulcerative colitis. This study will test the safety and efficacy of mesalazine in keeping ulcerative colitis in remission.

Detailed description:

Arms:
arm 1: Mesalazine arm 2: None

Interventions: intervention 1: SPD476 intervention 2: Asacol
Intervention descriptions: intervention 1: 2.4 g/day Once Daily (QD) intervention 2: 1.6g/day administered 800 mg Twice Daily (BID)

Protocol document: