Study Evaluating Subcutaneous MOA-728 for the Treatment of OIC in Subjects With Chronic Non-Malignant Pain - Full Text View

Sponsors and Collaborators:	Wyeth Progenics Pharmaceuticals, Inc.
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00529087

Purpose

The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have Opioid-Induced Constipation (OIC).

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

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), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Mulitcenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation in Subjects With Chronic Non-Malignant Pain

Further study details as provided by Wyeth:

Primary Outcome Measures:

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

Estimated Enrollment:	470
Study Start Date:	August 2007
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 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) Subcutaneous
3: Experimental	Drug: N-methylnaltrexone bromide (MOA-728) Subcutaneous

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 constipation and chronic non-malignant pain.
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: NCT00529087

Show 78 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:	3200K1-3356
Study First Received:	September 11, 2007
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00529087
Health Authority:	Canada: Health Canada; United States: Food and Drug Administration

Keywords provided by Wyeth:

Opioid-Induced Constipation

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 15, 2009