At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 148 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Mesalamine Granules 750 mgfrom 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 Phase II, Randomized, Placebo-controlled, Double-blind, Multicenter, 12 Week Study to Assess the Efficacy and Safety of Mesalamine Granules 750 mg and 1,500 mg Capsules Administered Once Daily in the Treatment of Irritable Bowel Syndrome With Diarrhea
In Brief
A Phase 2 clinical trial evaluating Placebo, Mesalamine Granules 750 mg, and 1 other intervention for Irritable Bowel Syndrome With Diarrhea. Completed, enrolled 148 participants across 20 sites.
Detailed Summary
The purpose of this study is to determine the daily dose of mesalamine granules that will provide adequate relief from symptoms of IBS with diarrhea.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome With Diarrhea
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2010
First PostedAug 2010
Primary CompletionAug 2011
TodayJul 2026
First PostedAug 9, 2010
Enrollment StartJul 1, 2010
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.9 years ago
Interventions
Placebodrug
placebo capsules once daily for 12 weeks
Mesalamine Granules 750 mgdrug
750 mg mesalamine granules once daily for 12 weeks
Mesalamine Granules 1500 mgdrug
1500 mg mesalamine granules once daily for 12 weeks