drugset / Trial / NCT00672477
Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness
Phase 4
Completed
237 enrolled
Bausch Health Americas, Inc.
Progenics Pharmaceuticals, Inc. · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2008-06
- Primary completion
- 2013-02
- Completion
- 2013-02
Outcome
Met primary endpoint
registry analysis (superiority or other test); Methylnaltrexone Bromide vs Placebo; p < 0.0001; Cochran-Mantel-Haenszel NCT00672477 ↗
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.
- Janku F, Johnson LK, Karp DD, Atkins JT, Singleton PA, Moss J. Treatment with methylnaltrexone is associated with increased survival in patients with advanced cancer. Ann Oncol. 2016 Nov;27(11):2032-2038. doi: 10.1093/annonc/mdw317. Epub 2016 Aug 29.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylnaltrexone | Other / unclassified | 8 mg | Subcutaneous |
| Subject | Methylnaltrexone | Other / unclassified | 12 mg | Subcutaneous |