drugset / Trial / NCT00529087
Study Evaluating Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation (OIC) in Subjects With Chronic Non-Malignant Pain
Phase 3
Completed
460 enrolled
Bausch Health Americas, Inc.
Progenics Pharmaceuticals, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have Opioid-Induced Constipation (OIC).
Timeline
- Start
- 2007-08
- Primary completion
- 2008-12
- Completion
- 2008-12
Outcome
Met primary endpoint
registry MOA-728 QD and MOA-728 QOD vs Placebo; p <0.001; Treatment Difference 24.4 (95% CI 17.3 to 31.4); Chi-squared NCT00529087 ↗
registry MOA-728 QD vs Placebo QD; p <0.001; Treatment Difference 19.5 (95% CI 15.1 to 24.0); t-test, 2 sided NCT00529087 ↗
registry MOA-728 QOD vs Placebo QD (Only QOD Injections); p <0.001; Treatment Difference 20.9 (95% CI 16.1 to 25.7); t-test, 2 sided NCT00529087 ↗
Publications
- Liao SS, Slatkin NE, Stambler N. The Influence of Age on Central Effects of Methylnaltrexone in Patients with Opioid-Induced Constipation. Drugs Aging. 2021 Jun;38(6):503-511. doi: 10.1007/s40266-021-00850-w. Epub 2021 Mar 31.
- Michna E, Weil AJ, Duerden M, Schulman S, Wang W, Tzanis E, Zhang H, Yu D, Manley A, Randazzo B. Efficacy of subcutaneous methylnaltrexone in the treatment of opioid-induced constipation: a responder post hoc analysis. Pain Med. 2011 Aug;12(8):1223-30. doi: 10.1111/j.1526-4637.2011.01189.x. Epub 2011 Aug 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylnaltrexone | Other / unclassified | 12 mg | Subcutaneous |