NCT00577473

Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)

A Double-blind, Randomized, 6 Week, Parallel-group Design Clinical Trial in Patients With Mildly to Moderately Active Ulcerative Colitis to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: Warner Chilcott · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet

Detailed description

This study is designed to evaluate the safety and efficacy of 4.8 g/day using 800 mg Asacol tablets as compared to 2.4g/day using 400 mg Asacol tablets in newly- and previously-diagnosed patients who are experiencing a flare-up of mildly to moderately active ulcerative colitis.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	mesalamine	mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
DRUG	mesalamine	mesalamine 4.8 g/day (800 mg tablet) for 6 weeks

Timeline

• Start date: 2001-02-01
• Primary completion: 2003-02-01
• Completion: 2003-02-01
• First posted: 2007-12-20
• Last updated: 2011-09-16
• Results posted: 2011-06-22

Locations

44 sites across 1 country: United States