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A Randomized, Double-Blind, Placebo-Controlled Study Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Adults With Advanced Illness And Opioid-Induced Constipation: Efficacy, Safety, And Additional Health Outcomes
This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.
Details
| Lead sponsor | Bausch Health Americas, Inc. |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 237 |
| Start date | 2008-06 |
| Completion | 2013-02 |
Conditions
- Opioid-Induced Constipation
Interventions
- Methylnaltrexone
- Placebo
Primary outcomes
- The Proportion of Subjects Who Have a Rescue-free Laxation Response Within 4 Hours After at Least 2 of the First 4 Doses — 7 days
This outcome measures the proportion of subjects who had a rescue-free laxation (ie, bowel movement) within 4 hours after at least 2 of the first 4 doses of study drug. A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation.
Countries
United States, Australia, Belgium, Brazil, Canada, France, Germany, Italy, Mexico, Spain, Sweden, United Kingdom