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.

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00366431

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 II

MedlinePlus related topics: Constipation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Wyeth:

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

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	3200A3-200
Study First Received:	August 18, 2006
Last Updated:	December 3, 2007
ClinicalTrials.gov Identifier:	NCT00366431
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: National Agency for Medicines; 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 Wyeth:

OIBD
OIC
Opioid
Constipation
Laxative

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Constipation
Pain

ClinicalTrials.gov processed this record on January 16, 2009