Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01177410
First received: July 30, 2010
Last updated: August 28, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Irritable Bowel Syndrome With Diarrhea
Drug: Placebo
Drug: Mesalamine Granules 750 mg
Drug: Mesalamine Granules 1500 mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 148
Study Start Date: July 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01177410

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
St. 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
St. 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
Salix Pharmaceuticals
  More Information

No publications provided

Responsible Party: Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01177410     History of Changes
Other Study ID Numbers: MGIB2051
Study First Received: July 30, 2010
Results First Received: August 21, 2012
Last Updated: August 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:
IBS
Diarrhea
IBS-D
Irritable Bowel Syndrome
Abdominal pain
Bloating

Additional relevant MeSH terms:
Syndrome
Diarrhea
Irritable Bowel Syndrome
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014