NCT00073021

Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis

A Double-Blind, Randomized, 6-Week, Parallel-Group Design Clinical Trial to Assess Safety and Efficacy of Asacol 4.8 g/Day (800 mg Tablet) Versus Asacol 2.4 g/Day (400 mg Tablet) for the Treatment of Moderately Active Ulcerative Colitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 386 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet formulation will be evaluated at one of the two doses.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Asacol 800 mg (mesalamine)	tablets, 4.8 g/day for 6 weeks, 2 - 800 mg Asacol tablets and 2 placebo tablets 3 times daily
DRUG	Asacol 400 mg (mesalamine)	tablets, 2.4 g/day for 6 weeks, 2 - 400 mg Asacol tablets and 2 placebo tablets 3 times daily

Timeline

• Start date: 2000-09-01
• Primary completion: 2003-09-01
• Completion: 2003-09-01
• First posted: 2003-11-17
• Last updated: 2015-06-29
• Results posted: 2011-07-28

Locations

57 sites across 3 countries: United States, Canada, Puerto Rico