A Study of Sativex® for Relief of Peripheral Neuropathic Pain Associated With Allodynia.

Phase 3 Completed 125 enrolled Jazz Pharmaceuticals

RandomizedParallel-groupQuadruple-blindSupportive care

Summary

The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in relieving peripheral neuropathic pain associated with allodynia.

Timeline

Start: 2002-05
Primary completion: 2004-03
Completion: 2004-03

Outcome

Met primary endpoint

paper The mean reduction in pain intensity scores (primary outcome measure) was greater in patients receiving sativex than placebo PMID 17997224 ↗

registry analysis (unspecified test); Sativex vs Placebo; p = 0.004; Estimated mean treatment difference -0.96 (95% CI -1.59 to -0.32); ANCOVA NCT00711880 ↗

Publications

Results Nurmikko TJ, Serpell MG, Hoggart B, Toomey PJ, Morlion BJ, Haines D. Sativex successfully treats neuropathic pain characterised by allodynia: a randomised, double-blind, placebo-controlled clinical trial. Pain. 2007 Dec 15;133(1-3):210-20. doi: 10.1016/j.pain.2007.08.028. Epub 2007 Nov 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nabiximols	Other / unclassified	—	Other