At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,027 enrolled
Drug / intervention
Mesalamine Once-Daily +1 moredrug
Likely dose
Mesalamine Once-Daily 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 Multi-center, Investigator-blinded, Randomized, 12-month, Parallel-group, Non-inferiority Study to Compare the Efficacy of 1.6 to 2.4 g Asacol® Therapy QD Versus Divided Dose (BID) in the Maintenance of Remission of Ulcerative Colitis
In Brief
A Phase 3 clinical trial evaluating Mesalamine Once-Daily and Mesalamine Twice-Daily for Ulcerative Colitis. Completed, enrolled 1,027 participants across 245 sites in 3 countries.
Detailed Summary
The purpose of this study is to compare the efficacy in maintaining remission of ulcerative colitis between a once daily (QD) Asacol regimen and a divided, twice daily (BID) Asacol dosing regimen.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesCanada, Puerto Rico, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2007
First PostedJul 2007
Primary CompletionJul 2009
TodayJul 2026
First PostedJul 23, 2007
Enrollment StartJul 1, 2007
Primary CompletionJul 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 18.9 years ago
Interventions
Mesalamine Once-Dailydrug
Mesalamine tablets, 1.6-2.4 g/day taken orally once a day for 52 weeks
Mesalamine Twice-Dailydrug
Mesalamine tablets, 1.6-2.4 g/day, taken twice daily for 52 weeks