Study Evaluating Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation (OIC) in Subjects With Chronic Non-Malignant Pain
NCT ID: NCT00529087
Last Updated: 2019-11-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
460 participants
INTERVENTIONAL
2007-08-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
placebo
placebo
2
N-methylnaltrexone bromide (MOA-728)
Subcutaneous
3
N-methylnaltrexone bromide (MOA-728)
Subcutaneous
Interventions
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N-methylnaltrexone bromide (MOA-728)
Subcutaneous
placebo
placebo
Eligibility Criteria
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Inclusion Criteria
* Taking oral, transdermal, intravenous, or subcutaneous opioids.
* Willingness to discontinue all pre-study laxative therapy and use only study permitted rescue laxatives.
Exclusion Criteria
* Other GI disorders known to affect bowel transit.
* Women who are pregnant, breast-feeding, or plan to become pregnant.
18 Years
ALL
No
Sponsors
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Progenics Pharmaceuticals, Inc.
INDUSTRY
Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jeff Cohn
Role: STUDY_DIRECTOR
Bausch Health Americas, Inc.
Locations
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Mobile, Alabama, United States
Mobile, Alabama, United States
Sun City, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Hot Springs, Arkansas, United States
Anaheim, California, United States
Garden Grove, California, United States
Hawaiian Gardens, California, United States
Long Beach, California, United States
Los Angeles, California, United States
San Diego, California, United States
Brandon, Florida, United States
Cheifland, Florida, United States
Clearwater, Florida, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
Largo, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Ocala, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
Ormond Beach, Florida, United States
Spring Hill, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Stockbridge, Georgia, United States
Chicago, Illinois, United States
DeKalb, Illinois, United States
Avon, Indiana, United States
Indianapolis, Indiana, United States
West Des Moines, Iowa, United States
Shreveport, Louisiana, United States
Sunset, Louisiana, United States
Elkridge, Maryland, United States
Boston, Massachusetts, United States
Brockton, Massachusetts, United States
Cadillac, Michigan, United States
Paw Paw, Michigan, United States
Traverse City, Michigan, United States
Biloxi, Mississippi, United States
Ocean Springs, Mississippi, United States
Nixa, Missouri, United States
Kalispell, Montana, United States
Missoula, Montana, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Albuquerque, New Mexico, United States
Great Neck, New York, United States
Valley Stream, New York, United States
Charlotte, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Dayton, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Medford, Oregon, United States
Portland, Oregon, United States
Levittown, Pennsylvania, United States
Chattanooga, Tennessee, United States
Austin, Texas, United States
Beaumont, Texas, United States
Colleyville, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Alexandria, Virginia, United States
Christiansburg, Virginia, United States
Hampton, Virginia, United States
Spokane, Washington, United States
Spokane, Washington, United States
Charleston, West Virginia, United States
Countries
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References
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Liao SS, Slatkin NE, Stambler N. The Influence of Age on Central Effects of Methylnaltrexone in Patients with Opioid-Induced Constipation. Drugs Aging. 2021 Jun;38(6):503-511. doi: 10.1007/s40266-021-00850-w. Epub 2021 Mar 31.
Michna E, Weil AJ, Duerden M, Schulman S, Wang W, Tzanis E, Zhang H, Yu D, Manley A, Randazzo B. Efficacy of subcutaneous methylnaltrexone in the treatment of opioid-induced constipation: a responder post hoc analysis. Pain Med. 2011 Aug;12(8):1223-30. doi: 10.1111/j.1526-4637.2011.01189.x. Epub 2011 Aug 2.
Other Identifiers
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3200K1-3356
Identifier Type: -
Identifier Source: org_study_id
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