At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 301 enrolled
Drug / intervention
mesalamine +1 moredrug
Likely dose
mesalamine 2.4 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Randomized, 6 Week, Parallel-group Design Clinical Trial in Patients With Mildly to Moderately Active Ulcerative Colitis to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day
In Brief
A Phase 3 clinical trial evaluating mesalamine for Ulcerative Colitis. Completed, enrolled 301 participants across 44 sites.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2001
Primary CompletionFeb 2003
First PostedDec 2007
TodayJul 2026
First PostedDec 20, 2007
Enrollment StartFeb 1, 2001
Primary CompletionFeb 1, 2003
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 18.5 years ago
Interventions
mesalaminedrug
mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
mesalaminedrug
mesalamine 4.8 g/day (800 mg tablet) for 6 weeks