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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00547586
Recruitment Status : Completed
First Posted : October 22, 2007
Last Update Posted : July 28, 2011
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
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)

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

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT00547586

  Hide Study Locations
United States, Alabama
Mobile, Alabama, United States, 36608
United States, Arizona
Hot Springs, Arizona, United States, 71901
Hot Springs, Arizona, United States, 71903
Litchfield Park, Arizona, United States, 85340
Tucson, Arizona, United States, 85710
Tucson, Arizona, United States, 85741
United States, California
Garden Grove, California, United States, 92843
Long Beach, California, United States, 90813
Los Angelese, California, United States, 90048
Maretta, California, United States, 30060
San Diego, California, United States, 92121
United States, Florida
Chiefland, Florida, United States, 32626
Jacksonville, Florida, United States, 32216
Jupiter, Florida, United States, 33458
Largo, Florida, United States, 33770
Naples, Florida, United States, 34104
Ocala, Florida, United States, 34471
Ormond Beach, Florida, United States, 32174
Spring Hill, Florida, United States, 34609
United States, Illinois
Chicago, Illinois, United States, 60610
United States, Indiana
Indianapolis, Indiana, United States, 46250
United States, Louisiana
Sunset, Louisiana, United States, 70584
United States, Maryland
Elkridge, Maryland, United States, 21075
United States, Massachusetts
Brockton, Massachusetts, United States, 2301
United States, Michigan
Cadillac, Michigan, United States, 49601
Traverse City, Michigan, United States, 49684
United States, Mississippi
Biloxi, Mississippi, United States, 39531
Ocean Springs, Mississippi, United States, 39564
United States, Nevada
Las Vegas, Nevada, United States, 89119
United States, New Mexico
Albuquerque, New Mexico, United States, 87102
United States, North Carolina
Charlotte, North Carolina, United States, 28204
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Dayton, Ohio, United States, 45439
Toledo, Ohio, United States, 43623
United States, Oregon
Meford, Oregon, United States, 97504
United States, Tennessee
Chattanooga, Tennessee, United States, 37404
United States, Texas
Beaumont, Texas, United States, 77701
Colleyville, Texas, United States, 76034
Dallas, Texas, United States, 75230
San Antonio, Texas, United States, 78229
United States, Virginia
Alexandria, Virginia, United States, 22304
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Progenics Pharmaceuticals, Inc.
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party: Jeff Cohn, Salix Pharmaceuticals 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:
Signs and Symptoms, Digestive
Signs and Symptoms
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents