CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 61 enrolled
Drug / intervention
Mesalamine +1 moredrug
Likely dose
Mesalamine 1.2gfrom 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/NCT01412372
NCT01412372Phase 3Completed
CompareCT.gov

The Effect of Long-Acting Mesalamine on Post-Infective Irritable Bowel Syndrome- A Pilot Study

University of Utah·interventional·Posted Aug 9, 2011·Updated Dec 31, 2020

In Brief

A Phase 3 clinical trial evaluating Mesalamine and Placebo for Irritable Bowel Syndrome. Completed, enrolled 61 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the effects of long acting mesalamine (Lialda) in patients with Post-Infective Irritable Bowel Syndrome (PI-IBS). The investigators will evaluate gastrointestinal symptoms, IBS specific quality of life (IBS-QOL), and plasma cytokines before and after treatment with Lialda.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome
CountriesUnited States
CollaboratorsShire Human Genetic Therapies, Inc.

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 9, 2011
Enrollment StartJun 1, 2010
Primary CompletionApr 22, 2019
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 14.9 years ago

Interventions

Mesalaminedrug

2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo

Placebodrug

This is an inactive pill