Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness
NCT ID: NCT00672477
Last Updated: 2018-03-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
237 participants
INTERVENTIONAL
2008-06-30
2013-02-28
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
DOUBLE
Study Groups
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Methylnaltrexone
Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; or 0.4 mL (8 mg) every other day if weight between 38 and \<62 kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information.
Methylnaltrexone
Placebo
Placebo subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL every other day if weight ≥ 62kg; or 0.4 mL every other day if weight between 38 and \< 62 kg. Subjects with impaired kidney function received reduced volumes of placebo solution to match the volumes used in the experimental group.
Placebo
Interventions
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Methylnaltrexone
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has a diagnosis of advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease)
* Has a life expectancy of at least 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 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.
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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Enoch Bortey
Role: STUDY_DIRECTOR
Bausch Health Americas, Inc.
Locations
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Salix Investigational Site
Mobile, Alabama, United States
Salix Investigational Site
Laguna Hills, California, United States
Salix Investigational Site
Lancaster, California, United States
Salix Investigational Site
Aurora, Colorado, United States
Salix Investigational Site
Auburndale, Florida, United States
Salix Investigational Site
Hudson, Florida, United States
Salix Investigational Site
Lakeland, Florida, United States
Salix Investigational Site
Lakeland, Florida, United States
Salix Investigational Site
Miami Springs, Florida, United States
Salix Investigational Site
Ruskin, Florida, United States
Salix Investigational Site
Sebring, Florida, United States
Salix Investigational Site
Tampa, Florida, United States
Salix Investigational Site
Tampa, Florida, United States
Salix Investigational Site
Tampa, Florida, United States
Salix Investigational Site
Temple Terrace, Florida, United States
Salix Investigational Site
West Palm Beach, Florida, United States
Salix Investigational Site
Orange, New Jersey, United States
Salix Investigational Site
Albuquerque, New Mexico, United States
Salix Investigational Site
Flat Rock, North Carolina, United States
Salix Investigational Site
Winston-Salem, North Carolina, United States
Salix Investigational Site
Cleveland, Ohio, United States
Salix Investigational Site
Philadelphia, Pennsylvania, United States
Salix Investigational Site
Austin, Texas, United States
Salix Investigational Site
Houston, Texas, United States
Salix Investigational Site
American Fork, Utah, United States
Salix Investigational Site
Orem, Utah, United States
Salix Investigational Site
Provo, Utah, United States
Salix Investigational Site
Salt Lake City, Utah, United States
Salix Investigational Site
Madison, Wisconsin, United States
Salix Investigational Site
Darlinghurst, New South Wales, Australia
Salix Investigational Site
Coburg, Victoria, Australia
Salix Investigational Site
East Melbourne, Victoria, Australia
Salix Investigational Site
Leuven, , Belgium
Salix Investigational Site
Liberdade, São Paulo, Brazil
Salix Investigational Site
São Paulo, São Paulo, Brazil
Salix Investigational Site
Edmonton, Alberta, Canada
Salix Investigational Site
Winnipeg, Manitoba, Canada
Salix Investigational Site
Hamilton, Ontario, Canada
Salix Investigational Site
Montreal, Quebec, Canada
Salix Investigational Site
Montreal, Quebec, Canada
Salix Investigational Site
Québec, Quebec, Canada
Salix Investigational Site
Besançon, , France
Salix Investigational Site
Bordeaux, , France
Salix Investigational Site
Bordeaux, , France
Salix Investigational Site
Grenoble, , France
Salix Investigational Site
Montpellier, , France
Salix Investigational Site
Villejuif, , France
Salix Investigational Site
Aachen, , Germany
Salix Investigational Site
Berlin, , Germany
Salix Investigational Site
München, , Germany
Salix Investigational Site
L’Aquila, , Italy
Salix Investigational Site
Milan, , Italy
Salix Investigational Site
Milan, , Italy
Pfizer Investigational Site
Mexico City DF, , Mexico
Salix Investigational Site
Barcelona, , Spain
Salix Investigational Site
L'Hospitalet de Llobregat, , Spain
Salix Investigational Site
Seville, , Spain
Salix Investigational Site
Kungsbacka, , Sweden
Salix Investigational Site
Norrköping, , Sweden
Salix Investigational Site
Cheltenham, Gloucestershire, United Kingdom
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.
Janku F, Johnson LK, Karp DD, Atkins JT, Singleton PA, Moss J. Treatment with methylnaltrexone is associated with increased survival in patients with advanced cancer. Ann Oncol. 2016 Nov;27(11):2032-2038. doi: 10.1093/annonc/mdw317. Epub 2016 Aug 29.
Other Identifiers
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B2541005
Identifier Type: -
Identifier Source: secondary_id
3200K1-4000
Identifier Type: -
Identifier Source: org_study_id
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