Study Evaluating MOA-728 Oral for the Treatment of OIBD in Subjects With Chronic Non-Malignant Pain

This study has been completed.

First Received on January 18, 2008. Last Updated on July 22, 2011 History of Changes

Sponsor:	Salix Pharmaceuticals
Collaborator:	Progenics Pharmaceuticals, Inc.
Information provided by:	Salix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00605644

Purpose

The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects administered MOA-728 who have chronic pain that is not due to cancer, and who have opioid-induced bowel dysfunction (OIBD).

Condition	Intervention	Phase
Constipation	Drug: MOA-728 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) 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 Nonmalignant 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:

Spontaneous Bowel Movements [ Time Frame: App. 1 month ] [ Designated as safety issue: No ]

Enrollment:	120
Study Start Date:	January 2008
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Placebo	Drug: Placebo Placebo
Experimental: 2 MOA-728	Drug: MOA-728 Oral Capsules
Experimental: 3 MOA-728	Drug: MOA-728 Oral Capsules
Experimental: 4 MOA-728	Drug: MOA-728 Oral Capsules
Experimental: 5 MOA-728	Drug: MOA-728 Oral Capsules

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 pain, which is not due to malignant cancer.
Taking oral, transdermal, intravenous, or subcutaneous opioids.
Willingness to discontinue all pre-study laxative therapy and use 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: NCT00605644

Sponsors and Collaborators

Salix Pharmaceuticals

Progenics Pharmaceuticals, Inc.

Investigators

Study Director:

Jeff Cohn

Salix Pharmaceuticals

More Information

No publications provided

Responsible Party:	Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00605644 History of Changes
Other Study ID Numbers:	3200A3-2202
Study First Received:	January 18, 2008
Last Updated:	July 22, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on February 12, 2012