Study Evaluating Subcutaneous MOA-728 For Treatment of Opioid-Induced Constipation in Patients With Advanced Illness

This study is currently recruiting participants.

Verified by Wyeth, October 2009

First Received: May 2, 2008 Last Updated: October 13, 2009 History of Changes

Sponsor:	Wyeth
Collaborator:	Progenics Pharmaceuticals, Inc.
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00672477

Purpose

This study will evaluate the safety and efficacy of a subcutaneous injection of methylnaltrexone in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.

Condition	Intervention	Phase
Opioid-induced Constipation	Drug: Methylnaltrexone bromide (MOA-728) Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study of a Fixed Dose of Subcutaneous Methylnaltrexone in Adults With Advanced Illness and Opioid-Induced Constipation: Efficacy, Safety, and Additional Health Outcomes

Resource links provided by NLM:

MedlinePlus related topics: Constipation

Drug Information available for: Methylnaltrexone bromide Methylnaltrexone

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

The effect of the intervention will be measured by bowel movements. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bowel movements and health outcome measures [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	350
Study Start Date:	May 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Methylnaltrexone bromide (MOA-728)
2: Placebo Comparator	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Is an adult 18 years of age or older
Has a diagnosis of advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease) with a life expectancy of greater than or equal to 1 month.
Is receiving opioids on a regular schedule (not just as-needed or rescue doses) for the control of pain or discomfort for at least 2 weeks before the first dose of study drug,
Has constipation that is caused by opioid medications

Exclusion Criteria:

Has received previous treatment with methylnaltrexone.
Has a known or suspected allergy to methylnaltrexone or other similar compounds (e.g. naltrexone or naloxone).
Has a known or suspected mechanical gastrointestinal obstruction.
Has any potential nonopioid cause of bowel dysfunction that might be a major contributor to the constipation.
Has any other clinically important abnormalities as determined by the investigator that may interfere with his or her participation in or compliance with the study.
Receiving opioid antagonist or partial antagonist products

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672477

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Show 83 Study Locations

Sponsors and Collaborators

Wyeth

Progenics Pharmaceuticals, Inc.

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3200K1-4000
Study First Received:	May 2, 2008
Last Updated:	October 13, 2009
ClinicalTrials.gov Identifier:	NCT00672477 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

opioid-induced constipation

Additional relevant MeSH terms:

Signs and Symptoms, Digestive
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Pharmacologic Actions
Signs and Symptoms
Sensory System Agents
Therapeutic Uses

Naltrexone
Constipation
Methylnaltrexone
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 20, 2009