Mesalamine Pellet Formulation to Maintain Remission of Mild to Moderate Ulcerative Colitis

Completed · Phase 3 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT00744016

Run by

Bausch Health Americas, Inc.

People needed

305

Starts

2004-12-01

Expected to finish

2007-10-01

Last updated by the study team

2019-11-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of ulcerative colitis and in remission for at least 1 month.
• Greater than 18 years of age.

You may not qualify if…

• 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.

Where it is running

• Study site — Bristol, Connecticut, United States

Full record on ClinicalTrials.gov

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