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Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation
This study is designed to evaluate the long-term safety and tolerability of the subcutaneous (SC) injection form of N-methylnaltrexone bromide (MOA-728) for the treatment of opioid-induced constipation in participants with nonmalignant pain. The study consists of a 2-week screening period, a 48-week open-label treatment period and a 2 week follow-up period. Participants will need to agree to self-administer SC injections, complete daily diaries, and check-in via a daily telephone call during the study.
Details
| Lead sponsor | Bausch Health Americas, Inc. |
|---|---|
| Phase | PHASE3 |
| Status | COMPLETED |
| Enrolment | 1040 |
| Start date | Wed Dec 03 2008 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon Sep 20 2010 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Constipation
Interventions
- N-methylnaltrexone bromide (MOA-728)
Countries
Colombia, South Korea, Canada, Australia, United States, Spain