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Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea

NCT01177410 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2019-11-21

Study results available
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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.

Conditions

  • Irritable Bowel Syndrome With Diarrhea

Interventions

DRUG

Placebo

placebo capsules once daily for 12 weeks

DRUG

Mesalamine Granules 750 mg

750 mg mesalamine granules once daily for 12 weeks

DRUG

Mesalamine Granules 1500 mg

1500 mg mesalamine granules once daily for 12 weeks

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01177410 on ClinicalTrials.gov