A Double Blind Study for the Treatment of Acute Ulcerative Colitis

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

Summary

A Double-blind, Randomized, 6-week, Parallel-group Design Clinical trial to assess the Safety and Efficacy of Asacol 4.8 g/day (800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mg mesalamine tablet) for the Treatment of Moderately Active Ulcerative Colitis (ASCEND III).

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

Details

• Lead Sponsor: Warner Chilcott
• Treatments: Mesalamine

Criteria

Inclusion Criteria:

• Patients 18-75 years with a confirmed diagnosis of moderately active flare of ulcerative colitis.

• Female patients need to be postmenopausal or using adequate contraception.

Exclusion Criteria:

• Patients with isolated proctitis

• Patients with comorbidities or an investigative or commercialized treatments confounding interpretation of study results or compromising patients' safety in the trial.