Dataset from A Phase III, Randomized Multi-centre, Double-blind, Parallel Group, Active Comparator Study to Compare the Efficacy and Safety of SPD476 (Mesalazine)2.4g/Day Once Daily With Asacol 1.6g/Day Twice Daily in the Maintenance of Remission in Patients With Ulcerative Colitis

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.