Study Evaluating Oral MOA-728 For The Treatment Of OIBD In Subjects With Chronic Non-Malignant Pain - Full Text View

Sponsors and Collaborators:	Wyeth Progenics Pharmaceuticals, Inc.
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00547586

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 with chronic pain, which is not due to malignant cancer, and who have opioid-induced bowel dysfunction (OIBD).

Condition	Intervention	Phase
Constipation	Drug: N-methylnaltrexone bromide (MOA-728) Other: placebo	Phase II

MedlinePlus related topics: Constipation

Drug Information available for: Methylnaltrexone Methylnaltrexone bromide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active 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 Nonmalignant Pain

Further study details as provided by Wyeth:

Primary Outcome Measures:

The effect of the interventional treatment will be measured by bowel movements. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment:	120
Study Start Date:	October 2007
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Other: placebo placebo
2: Experimental	Drug: N-methylnaltrexone bromide (MOA-728) Oral
3: Experimental	Drug: N-methylnaltrexone bromide (MOA-728) Oral
4: Experimental	Drug: N-methylnaltrexone bromide (MOA-728) Oral
5: Experimental	Drug: N-methylnaltrexone bromide (MOA-728) Oral

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: NCT00547586

Show 42 Study Locations

Sponsors and Collaborators

Wyeth

Progenics Pharmaceuticals, Inc.

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3200A3-2201
Study First Received:	October 19, 2007
Last Updated:	August 13, 2008
ClinicalTrials.gov Identifier:	NCT00547586
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Bromides
Naltrexone

Constipation
Methylnaltrexone
Pain

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Narcotic Antagonists

Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009