NCT01177410

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

Completed Phase 2 Results posted Last updated 13 November 2019

What this trial tests

Phase 2 trial testing Placebo in Irritable Bowel Syndrome With Diarrhea in 148 participants. Completed in 1 August 2011.

Timeline

1 July 2010

Primary endpoint
1 August 2011

1 August 2011

Quick facts

Lead sponsor	Bausch Health Americas, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	148
Start date	1 July 2010
Primary completion	1 August 2011
Estimated completion	1 August 2011
Sites	20 locations across United States

Drugs / interventions tested

• Placebo
• Mesalamine Granules 750 mg — full drug profile →
• Mesalamine Granules 1500 mg — full drug profile →

Conditions studied

• Irritable Bowel Syndrome With Diarrhea — all drugs for Irritable Bowel Syndrome With Diarrhea →

Sponsor

Bausch Health Americas, Inc. — full company profile →

Who can join

18 and older, any sex, with Irritable Bowel Syndrome With Diarrhea. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three Months.
  Time frame: 3 months
  A weekly responder in abdominal pain is defined as a ≥30% improvement from baseline in the weekly average abdominal pain score on a 10-point scale (0=no pain - 10= worst possible pain). A weekly responder in stool consistency is defined as ≥50% reduction in the number of days in a week with stool consistency of Type 6 or 7 compared with baseline using the Bristol Stool Scale. Monthly responders ar

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Literature Review of Major Clinical Trials That Contributed to Treatment Protocols of Irritable Bowel Syndrome With Diarrhea.
   Elsaygh H, Alhafez I, Jaber M, Al-Rasheed M, et al · · 2022 · cited 1× · PMID 35875271 · DOI 10.7759/cureus.26092