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

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.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome With Diarrhea
• Intervention / Treatment: Drug: Placebo; Drug: Mesalamine Granules 750 mg; Drug: Mesalamine Granules 1500 mg

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Sherwood, Arkansas, United States, 72120
  • California
    • Anaheim, California, United States, 92801
    • Sacramento, California, United States, 95831
    • San Diego, California, United States, 92108
    • San Francisco, California, United States, 94115
  • Connecticut
    • Bristol, Connecticut, United States, 06010
  • Florida
    • Boynton Beach, Florida, United States, 33426
    • Saint Petersburg, Florida, United States, 33709
  • Georgia
    • Macon, Georgia, United States, 31201
  • Louisiana
    • Shreveport, Louisiana, United States, 71103
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
    • Wyoming, Michigan, United States, 49519
  • Missouri
    • Mexico, Missouri, United States, 65265
    • Saint Louis, Missouri, United States, 63141
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
  • New York
    • New York, New York, United States, 10016
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
  • Texas
    • Plano, Texas, United States, 75075
  • Utah
    • Ogden, Utah, United States, 84405
  • Virginia
    • Lynchburg, Virginia, United States, 24502

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Months That Subjects Are Monthly Responders in Both IBS-related Abdominal Pain AND Stool Consistency During the Entire Three 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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	3 months

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: July 30, 2010
• First Submitted That Met QC Criteria: August 6, 2010
• First Posted (Estimate): August 9, 2010

Study Record Updates

• Last Update Posted (Actual): November 21, 2019
• Last Update Submitted That Met QC Criteria: November 13, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Diarrhea; IBS; Abdominal pain; Bloating; IBS-D
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Mesalamine
• Other Study ID Numbers: MGIB2051