Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness
NCT ID: NCT00672139
Last Updated: 2018-03-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
156 participants
INTERVENTIONAL
2008-07-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Methylnaltrexone bromide
Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study.
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 bromide
Interventions
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Methylnaltrexone bromide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is receiving opioids on a regular schedule, not just as needed to control pain.
* Likely to continue to need treatment of OIC for the duration of participation in the study.
Exclusion Criteria
* Currently using an opioid antagonist or partial antagonist.
* Has any other clinically important abnormalities such that risk to patient of participation outweighs the potential benefit of therapy as determined by the investigator
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
Orange, New Jersey, 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
Madison, Wisconsin, United States
Salix Investigational Site
Coburg, Victoria, Australia
Salix Investigational Site
East Melbourne, Victoria, Australia
Salix Investigational Site
Adelaide, , Australia
Salix Investigational Site
Leuven, , Belgium
Salix Investigational Site
Edmonton, Alberta, Canada
Salix Investigational Site
Edmonton, Alberta, Canada
Salix Investigational Site
Hamilton, Ontario, Canada
Salix Investigational Site
London, Ontario, Canada
Salix Investigational Site
Montreal, Quebec, Canada
Salix Investigational Site
Québec, Quebec, Canada
Salix Investigational Site
Montpellier, , France
Salix Investigational Site
Berlin, , Germany
Salix Investigational Site
L’Aquila, , Italy
Salix Investigational Site
Milan, , Italy
Salix Investigational Site
Milan, , Italy
Salix Investigational Site
Roma, , Italy
Pfizer Investigational Site
Mexico City DF, , Mexico
Salix Investigational Site
Almada, , Portugal
Salix Investigational Site
Porto, , Portugal
Salix Investigational Site
Cheltenham, Gloucestershire, United Kingdom
Countries
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Other Identifiers
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B2541006
Identifier Type: -
Identifier Source: secondary_id
3200K1-4001
Identifier Type: -
Identifier Source: org_study_id
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