Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis
Completed
Shire
Phase 3
2005-04-08
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.
Strategies in Maintenance for Patients Receiving Long-term Therapy (S.I.M.P.L.E.) With MMX (Multi-Matrix System) Mesalamine for Ulcerative Colitis (UC)
Completed
Shire
Phase 4
2007-05-01
To evaluate the percentage of subjects with clinical recurrence of UC at 6 months using MMX
mesalamine once daily.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phase 4
2008-09-01
The proposed study will test whether increasing Lialda dose can reduce fecal calprotectin
(FCP) levels, a marker of intestinal inflammation that is highly predictive of the risk of
relapse among patients with quiescent ulcerative colitis. Sixty patients with FCP levels
The proposed study will test whether increasing Lialda dose can reduce fecal calprotectin
(FCP) levels, a marker of intestinal inflammation that is highly predictive of the risk of
relapse among patients with quiescent ulcerative colitis. Sixty patients with FCP levels
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