Mesalamine Granules for Irritable Bowel Syndrome (IBS) With Diarrhea - Full Text View

Sponsor:	Salix Pharmaceuticals
Information provided by (Responsible Party):	Salix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01177410

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 II

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:

MedlinePlus related topics: Abdominal Pain Diarrhea

Drug Information available for: Mesalamine

U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:

The number of months that subjects are monthly responders for IBS-related abdominal pain [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	July 2010

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:

at least 18 years of age
diagnosed with IBS
recurrent abdominal pain or discomfort in the past 3 months

Exclusion Criteria:

currently experiencing hard or lumpy bowel movements
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

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

Los Angeles, California, United States, 90048

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
Last Updated:	December 22, 2011
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:

Diarrhea
Irritable Bowel Syndrome
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 February 21, 2012