Trials / Completed
CompletedNCT01177410
Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 148 (actual)
- Sponsor
- Bausch Health Americas, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2010-07-01
- Primary completion
- 2011-08-01
- Completion
- 2011-08-01
- First posted
- 2010-08-09
- Last updated
- 2019-11-21
- Results posted
- 2012-09-27
Locations
20 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01177410. Inclusion in this directory is not an endorsement.