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

• Status: Completed
• Trial end date: 2009-09-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Mesalamine

Criteria

Inclusion Criteria:

• previous diagnosis of ulcerative colitis confirmed by histology that has been considered to be in remission for => 30 days

• female subjects must be post-menopausal, surgically or biologically sterile, or with a negative urine pregnancy test at screening and on adequate contraception

Exclusion Criteria:

• proctitis

• previous resective colonic surgery

• Crohn's disease

• hypersensitivity to salicylates

• moderate/severe renal impairment