Status:
COMPLETED
Mesalamine Pellet Formulation to Maintain Remission of Mild to Moderate Ulcerative Colitis
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
This is a phase 3, multicenter, double-blind, randomized, placebo controlled study evaluating the effectiveness and safety of eMG 1.5 g given once daily (QD) compared with placebo in approximately 300...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of ulcerative colitis and in remission for at least 1 month.
- Greater than 18 years of age.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT00744016
Start Date
December 1 2004
End Date
October 1 2007
Last Update
November 27 2019
Active Locations (1)
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1
Bristol, Connecticut, United States, 06010