Study Evaluating Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction (OIBD) in Subjects With Chronic Non-Malignant Pain - Full Text View

Purpose

The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of MOA-728 in subjects with Opioid-Induced Bowel Dysfunction (OIBD) with associated chronic non-malignant pain.

Condition	Intervention	Phase
Constipation	Drug: MOA-728	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Non-Malignant Pain

Resource links provided by NLM:

MedlinePlus related topics: Constipation

U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:

The effect of the interventional treatment will be measured by the change from baseline in the number of bowel movements per week during the double-blind treatment period.

Estimated Enrollment:	420
Study Start Date:	August 2006
Study Completion Date:	March 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult outpatients with opioid-induced bowel dysfunction and chronic non-malignant pain.
Taking oral, transdermal, intravenous, or subcutaneous opioids.
Willingness to discontinue all pre-study laxative therapy and utilize only study permitted rescue laxatives.

Exclusion Criteria:

History of chronic constipation before the initiation of opioid therapy.
Other GI disorders known to affect bowel transit.
Women who are pregnant, breast-feeding, or plan to become pregnant.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366431

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Locations

United States, Alabama

Birmingham, Alabama, United States, 35244

Birmingham, Alabama, United States, 35215

Mobile, Alabama, United States, 36608
United States, Arizona

Phoenix, Arizona, United States, 85029

Tucson, Arizona, United States, 85741

Tucson, Arizona, United States, 85712

Tucson, Arizona, United States, 85710
United States, Arkansas

Hot Springs, Arkansas, United States, 71913
United States, California

Anaheim, California, United States, 92801

Anaheim, California, United States, 92805

Bakersfield, California, United States, 93311

Foothill Ranch, California, United States, 92610

Garden Grove, California, United States, 92843

Los Gatos, California, United States, 95032

Orange, California, United States, 92869

Sacramento, California, United States, 95831

San Diego, California, United States, 92121

San Diego, California, United States, 92120

San Diego, California, United States, 92108
United States, Connecticut

Trumbull, Connecticut, United States, 06611
United States, Florida

Hollywood, Florida, United States, 33021

Jacksonville, Florida, United States, 32216

Jupiter, Florida, United States, 33458

Largo, Florida, United States, 33770

Miami, Florida, United States, 33180

Miami, Florida, United States, 33173

Ocala, Florida, United States, 34471

Ormond Beach, Florida, United States, 32174

St. Cloud, Florida, United States, 34769

Tampa, Florida, United States, 33607

West Palm Beach, Florida, United States, 33401
United States, Georgia

Dawsonville, Georgia, United States, 30534

Marietta, Georgia, United States, 30066

Marietta, Georgia, United States, 30060
United States, Illinois

Bloomington, Illinois, United States, 61701

Chicago, Illinois, United States, 60610
United States, Indiana

Indianapolis, Indiana, United States, 46250
United States, Maryland

Elkridge, Maryland, United States, 21075
United States, Massachusetts

Boston, Massachusetts, United States, 02115

Brockton, Massachusetts, United States, 02301
United States, Michigan

Saginaw, Michigan, United States, 48602

Traverse City, Michigan, United States, 49684
United States, Mississippi

Picayune, Mississippi, United States, 39466
United States, Missouri

Independence, Missouri, United States, 64055
United States, Montana

Missoula, Montana, United States, 59808
United States, Nebraska

Omaha, Nebraska, United States, 68114
United States, Nevada

Reno, Nevada, United States, 89502
United States, New Jersey

Haddon Heights, New Jersey, United States, 08035
United States, New Mexico

Albuquerque, New Mexico, United States, 87102
United States, New York

Great Neck, New York, United States, 11023

Lake Success, New York, United States, 11042
United States, North Carolina

Charlotte, North Carolina, United States, 28210

Winston-Salem, North Carolina, United States, 27103
United States, Ohio

Cincinnati, Ohio, United States, 45224

Cincinnati, Ohio, United States, 45219

Dayton, Ohio, United States, 45439
United States, Oklahoma

Clinton, Oklahoma, United States, 73601
United States, Tennessee

Chattanooga, Tennessee, United States, 37404
United States, Texas

Beaumont, Texas, United States, 77701

Colleyville, Texas, United States, 76034

San Antonio, Texas, United States, 78205

San Antonio, Texas, United States, 78238

San Antonio, Texas, United States, 78209
United States, Virginia

Alexandria, Virginia, United States, 22304

Christiansburg, Virginia, United States, 24073

Norfolk, Virginia, United States, 23502

Richmond, Virginia, United States, 23229

Sponsors and Collaborators

Salix Pharmaceuticals

Investigators

Study Director:

Jeff Cohn

Salix Pharmaceuticals

More Information

No publications provided

Responsible Party:	Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00366431 History of Changes
Other Study ID Numbers:	3200A3-200
Study First Received:	August 18, 2006
Last Updated:	July 22, 2011
Health Authority:	Australia: National Health and Medical Research Council Brazil: Ministry of Health Canada: Health Canada China: Ministry of Health Denmark: National Board of Health European Union: European Medicines Agency Finland: Finnish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices Hong Kong: Department of Health Hungary: National Institute of Pharmacy Korea: Food and Drug Administration Mexico: National Institute of Public Health, Health Secretariat Netherlands: Medicines Evaluation Board (MEB) New Zealand: Food Safety Authority Norway: Norwegian Medicines Agency Poland: Ministry of Health Spain: Ministry of Health Sweden: Medical Products Agency Turkey: Ministry of Health United Kingdom: Department of Health United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:

OIBD
OIC
Opioid
Constipation
Laxative

Additional relevant MeSH terms:

Constipation
Intestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases
Analgesics, Opioid
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 16, 2013