drugset / Trial / NCT00402038
Study of Methylnaltrexone (MNTX) for the Relief of Constipation
Phase 3
Completed
134 enrolled
Bausch Health Americas, Inc.
Wyeth is now a wholly owned subsidiary of Pfizer · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
To determine the efficacy of subcutaneous MNTX to relieve opioid-induced constipation in patients with advanced medical illness.
Timeline
- Start
- 2004-02
- Primary completion
- 2005-10
- Completion
- 2005-10
Outcome
Met primary endpoint
paper 48% of patients had laxation within 4 hours after the first study dose, as compared with 15% in the placebo group PMID 18509120 ↗
paper P<0.001 for both comparisons PMID 18509120 ↗
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.
- Chamberlain BH, Rhiner M, Slatkin NE, Stambler N, Israel RJ. Subcutaneous methylnaltrexone for opioid-induced constipation in advanced-illness patients with or without active cancer. Pain Manag. 2020 Mar;10(2):73-84. doi: 10.2217/pmt-2019-0045. Epub 2020 Jan 17.
- Nalamachu SR, Pergolizzi J, Taylor R Jr, Slatkin NE, Barrett AC, Yu J, Bortey E, Paterson C, Forbes WP. Efficacy and Tolerability of Subcutaneous Methylnaltrexone in Patients with Advanced Illness and Opioid-Induced Constipation: A Responder Analysis of 2 Randomized, Placebo-Controlled Trials. Pain Pract. 2015 Jul;15(6):564-71. doi: 10.1111/papr.12218. Epub 2014 May 10.
- Lipman AG, Karver S, Cooney GA, Stambler N, Israel RJ. Methylnaltrexone for opioid-induced constipation in patients with advanced illness: a 3-month open-label treatment extension study. J Pain Palliat Care Pharmacother. 2011;25(2):136-45. doi: 10.3109/15360288.2011.573531.
- Thomas J, Karver S, Cooney GA, Chamberlain BH, Watt CK, Slatkin NE, Stambler N, Kremer AB, Israel RJ. Methylnaltrexone for opioid-induced constipation in advanced illness. N Engl J Med. 2008 May 29;358(22):2332-43. doi: 10.1056/NEJMoa0707377.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylnaltrexone | Other / unclassified | 0.15 mg/kg | Subcutaneous |
| Subject | Methylnaltrexone | Other / unclassified | 0.3 mg/kg | Subcutaneous |