Overview

Mesalamine Pellet Formulation 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.