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

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00366431
First received: August 18, 2006
Last updated: July 22, 2011
Last verified: July 2011
History of Changes
  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

  Show 67 Study Locations
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 19, 2013