A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy.

Summary

The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex in patients with advanced cancer, who experience inadequate pain relief even though they are on optimized chronic opioid therapy.

Timeline

Start

2007-11

Primary completion

2010-01

Completion

2010-01

Outcome

Missed primary endpoint

paper The 30% responder rate primary analysis was not significant for nabiximols versus placebo (overall P = .59). PMID 22483680 ↗

Publications

• Results Portenoy RK, Ganae-Motan ED, Allende S, Yanagihara R, Shaiova L, Weinstein S, McQuade R, Wright S, Fallon MT. Nabiximols for opioid-treated cancer patients with poorly-controlled chronic pain: a randomized, placebo-controlled, graded-dose trial. J Pain. 2012 May;13(5):438-49. doi: 10.1016/j.jpain.2012.01.003. Epub 2012 Apr 5.

Drugs

Indications