CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 7 enrolled
Drug / intervention
Mesalamine +1 moredrug
Likely dose
Mesalamine 375 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.

Search/NCT01327300
NCT01327300Phase 2Completed
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Randomized, Double-blind, Cross-over Study of the Efficacy of Mesalamine in Diarrhea-predominant Irritable Bowel Syndrome (dIBS)

University of Florida·interventional·Posted Apr 1, 2011·Updated Feb 12, 2014

In Brief

A Phase 2 clinical trial evaluating Mesalamine and Placebo for Irritable Bowel Syndrome. Completed, enrolled 7 participants across 1 site.

Detailed Summary

The purpose of this study is to find whether treating patients with diarrhea predominant Irritable Bowel Syndrome (IBS) with an anti-inflammatory drug called Mesalamine will help improve their symptoms of diarrhea, bloating and abdominal pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 1, 2011
Enrollment StartMar 1, 2010
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 15.3 years ago

Interventions

Mesalaminedrug

Apriso is a 5-ASA drug with Intellicor ™ extended-release delivery technology. A 1.5 gram dosage of Apriso (equaling four 375 mg capsules) once a day will be administered orally for a period of 12 weeks followed by a 3 week wash out prior to crossing over to the placebo arm.

Placeboother

4 capsules (.375 gm sugar pill capsules) administered orally once a day. This group will receive the placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.