NCT00151892

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 829 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	SPD476	2.4 g/day Once Daily (QD)
DRUG	Asacol	1.6g/day administered 800 mg Twice Daily (BID)

Timeline

• Start date: 2005-04-08
• Primary completion: 2009-09-07
• Completion: 2009-09-07
• First posted: 2005-09-09
• Last updated: 2021-06-14
• Results posted: 2010-09-21

Locations

142 sites across 28 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Czechia, Denmark, France, Germany, Hungary, India, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Romania, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan, United Kingdom