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

Summary

The purpose of this study is to determine whether Sativex® and GW-2000-02 are effective in the management of subjects with intractable cancer-related pain.

Timeline

Start

2002-02

Primary completion

2004-02

Completion

2004-03

Outcome

Mixed primary results

registry A negative value indicates an improvement in pain score from baseline. NCT00674609 ↗

registry analysis (unspecified test); Sativex vs Placebo; p = 0.014; estimated mean treatment difference -0.67 (95% CI -1.21 to -0.14); ANCOVA NCT00674609 ↗

registry analysis (unspecified test); Sativex vs Placebo; p = 0.688; estimated mean treatment difference -0.04 (95% CI -0.25 to 0.16); Regression, Logistic NCT00674609 ↗

Publications

• Results Johnson JR, Burnell-Nugent M, Lossignol D, Ganae-Motan ED, Potts R, Fallon MT. Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain. J Pain Symptom Manage. 2010 Feb;39(2):167-79. doi: 10.1016/j.jpainsymman.2009.06.008. Epub 2009 Nov 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nabiximols	Other / unclassified	25 mg/ml	Other
Subject	Nabiximols	Other / unclassified	27 mg/ml	Other
Subject	THC Alone	Unknown	27 mg/ml	Other

Indications