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

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ClinicalTrials.gov Identifier: NCT00547586
Recruitment Status : Completed
First Posted : October 22, 2007
Last Update Posted : July 28, 2011
Sponsor:
Collaborator:
Progenics Pharmaceuticals, Inc.
Information provided by:
Valeant Pharmaceuticals International, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Constipation Drug: N-methylnaltrexone bromide (MOA-728) Other: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

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



Primary Outcome Measures :
  1. The effect of the interventional treatment will be measured by bowel movements. [ Time Frame: 1 month ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00547586


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

Responsible Party: Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00547586     History of Changes
Other Study ID Numbers: 3200A3-2201
First Posted: October 22, 2007    Key Record Dates
Last Update Posted: July 28, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Bromides
Methylnaltrexone
Naltrexone
Anticonvulsants
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents