Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea

• ClinicalTrials.gov Identifier: NCT01177410
• Recruitment Status: Completed
• First Posted: August 9, 2010
• Results First Posted: September 27, 2012
• Last Update Posted: November 21, 2019
• Sponsor: Bausch Health Americas, Inc.
• Information provided by (Responsible Party): Bausch Health Americas, Inc.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Irritable Bowel Syndrome With Diarrhea	Drug: Placebo; Drug: Mesalamine Granules 750 mg; Drug: Mesalamine Granules 1500 mg	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 148 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: July 2010
• Actual Primary Completion Date: August 2011
• Actual Study Completion Date: August 2011

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo	Drug: Placebo; placebo capsules once daily for 12 weeks
Experimental: Mesalamine Granules 750 mg	Drug: Mesalamine Granules 750 mg; 750 mg mesalamine granules once daily for 12 weeks
Experimental: Mesalamine Granules 1500 mg	Drug: Mesalamine Granules 1500 mg; 1500 mg mesalamine granules once daily for 12 weeks

Outcome Measures

Primary Outcome Measures :

1. 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 are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks.

Secondary Outcome Measures :

1. Proportion of Subjects Who Are Monthly Responders in Both Abdominal Pain and Stool Consistency for at Least 2 Months During the 3-month Treatment Period [ 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 are subjects who are weekly responders in both abdominal pain and stool consistency for at least two out of four weeks.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

Male or non-pregnant, non-lactating female subjects Diagnosed with IBS confirmed by the Rome III criteria

Meet the following IBS symptom scores in all categories during the diary eligibility period:

• An average daily score of greater than or equal to 3 for abdominal pain
• An average daily score of greater than or equal to 3 for bloating
• An average daily score of 5 or greater for stool consistency using the Bristol Stool Scale
• Does not have adequate relief of IBS symptoms (weekly reported) over the past 7 days on the first day of screening and on the day of randomization

Exclusion Criteria:

• Present with hard or lumpy stools (Type 1 or Type 2) on the Bristol Stool form Scale during the diary eligibility period
• history of inflammatory bowel disease
• has Type 1 or 2 diabetes
• pregnant or lactating
• history of HIV or hepatitis B or C

Contacts and Locations

Locations

United States, Arkansas

Sherwood, Arkansas, United States, 72120

United States, California

Anaheim, California, United States, 92801

Sacramento, California, United States, 95831

San Diego, California, United States, 92108

San Francisco, California, United States, 94115

United States, Connecticut

Bristol, Connecticut, United States, 06010

United States, Florida

Boynton Beach, Florida, United States, 33426

Saint Petersburg, Florida, United States, 33709

United States, Georgia

Macon, Georgia, United States, 31201

United States, Louisiana

Shreveport, Louisiana, United States, 71103

United States, Michigan

Ann Arbor, Michigan, United States, 48109

Wyoming, Michigan, United States, 49519

United States, Missouri

Mexico, Missouri, United States, 65265

Saint Louis, Missouri, United States, 63141

United States, New Mexico

Albuquerque, New Mexico, United States, 87102

United States, New York

New York, New York, United States, 10016

United States, North Carolina

Greensboro, North Carolina, United States, 27408

United States, Texas

Plano, Texas, United States, 75075

United States, Utah

Ogden, Utah, United States, 84405

United States, Virginia

Lynchburg, Virginia, United States, 24502

Sponsors and Collaborators

Bausch Health Americas, Inc.

More Information

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT01177410
• Other Study ID Numbers: MGIB2051
• First Posted: August 9, 2010
• Results First Posted: September 27, 2012
• Last Update Posted: November 21, 2019
• Last Verified: November 2019

Keywords provided by Bausch Health Americas, Inc.:

IBS; Diarrhea; IBS-D; Irritable Bowel Syndrome; Abdominal pain; Bloating

Additional relevant MeSH terms:

Irritable Bowel Syndrome; Syndrome; Diarrhea; Disease; Pathologic Processes; Signs and Symptoms, Digestive; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Mesalamine; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents