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A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Cancer-Related Pain
This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks.
Details
| Lead sponsor | Bausch Health Americas, Inc. |
|---|---|
| Phase | Phase 4 |
| Status | WITHDRAWN |
| Start date | 2009-03 |
| Completion | 2009-08 |
Conditions
- Opioid-Induced Constipation
Interventions
- methylnaltrexone
- placebo
Primary outcomes
- Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments. — 1 Day
Countries
United States, Canada, France, Spain