At a glance
ClinicalIndex Comparison Record- ✓Previous diagnosis of ulcerative colitis confirmed by histology
- ✓Disease has been in remission for at least 30 days
- ✕Proctitis
- ✕Previous resective colonic surgery
- ✕Crohn's disease
- ✕Hypersensitivity to salicylates
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating SPD476 and Asacol for Ulcerative Colitis. Completed, enrolled 829 participants across 142 sites in 28 countries.
Detailed 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.
Study Details
Timeline
Interventions
2.4 g/day Once Daily (QD)
1.6g/day administered 800 mg Twice Daily (BID)