Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness
|ClinicalTrials.gov Identifier: NCT00672139|
Recruitment Status : Completed
First Posted : May 6, 2008
Results First Posted : March 7, 2018
Last Update Posted : March 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Opioid-Induced Constipation||Drug: Methylnaltrexone bromide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||156 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label Extension Study To Assess The Safety Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Subjects With Advanced Illness And Opioid-Induced Constipation|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||May 2013|
Experimental: 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.
Drug: Methylnaltrexone bromide
Other Name: Relistor
- Number of Laxations Per Subject Within 24 Hours of Dosing Per Week. [ Time Frame: 10 weeks ]This was defined as the total number of days with a laxation (ie, a bowel movement) within 24 hours after dosing in each 7-day interval after the start of dosing. Results shown are the ranges (lowest and highest weekly values) of mean (± standard deviation) numbers of laxations within 24 hours of dosing per week during the 10-week treatment period for each group.
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): NCT00672139
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|Study Director:||Enoch Bortey||Valeant Pharmaceuticals International, Inc.|