Mesalamine Pellet to Maintain Remission of Mild to Moderate Ulcerative Colitis

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the maintenance of mild to moderate ulcerative colitis remission with six months of treatment with 1.5 grams of mesalamine pellets each day versus placebo.

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

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Mesalamine

Criteria

Inclusion Criteria:

• Confirmed diagnosis of ulcerative colitis and in remission for at least 1 month

• Greater than 18 years of age

Exclusion Criteria:

• Allergy/intolerance to aspirin, mesalamine, or other salicylates

• Prior bowel surgery other than appendectomy

• Pregnancy, at risk of pregnancy, or lactating

• HIV or hepatitis B or C