drugset / Trial / NCT00401362
A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients
RandomizedParallel-groupTriple-blindTreatment
Summary
To test the effectiveness of MNTX in advanced illness subjects.
Timeline
- Start
- 2003-02
- Primary completion
- 2005-02
- Completion
- 2005-02
Outcome
Met primary endpoint
paper compared with 14% for placebo (P < 0.0001; each dose vs placebo). PMID 19278178 ↗
Publications
- 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.
- 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.
- 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.
- Slatkin N, Thomas J, Lipman AG, Wilson G, Boatwright ML, Wellman C, Zhukovsky DS, Stephenson R, Portenoy R, Stambler N, Israel R. Methylnaltrexone for treatment of opioid-induced constipation in advanced illness patients. J Support Oncol. 2009 Jan-Feb;7(1):39-46.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methylnaltrexone | Other / unclassified | 0.15 mg/kg | Subcutaneous |
| Subject | Methylnaltrexone | Other / unclassified | 0.3 mg/kg | Subcutaneous |