Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis

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.

Timeline

Start

2005-04-08

Primary completion

2009-09-07

Completion

2009-09-07

Drugs

Indications