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

This study has been completed.
Progenics Pharmaceuticals, Inc.
Information provided by:
Valeant Pharmaceuticals International, Inc. Identifier:
First received: October 19, 2007
Last updated: July 22, 2011
Last verified: July 2011
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
Drug: N-methylnaltrexone bromide (MOA-728)
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Further study details as provided by Valeant Pharmaceuticals International, Inc.:

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


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

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
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Please refer to this study by its identifier: NCT00547586

  Show 41 Study Locations
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Progenics Pharmaceuticals, Inc.
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Jeff Cohn, Salix Pharmaceuticals Identifier: NCT00547586     History of Changes
Other Study ID Numbers: 3200A3-2201
Study First Received: October 19, 2007
Last Updated: July 22, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Digestive
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 30, 2015