A Two-Part Study of Sativex® Oromucosal Spray for Relieving Uncontrolled Persistent Pain in Patients With Advanced Cancer

Phase 3 Completed 406 enrolled Jazz Pharmaceuticals Otsuka Pharmaceutical Development & Commercialization, Inc. · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

The primary objective of this study was to evaluate the efficacy of nabiximols (Sativex®), compared with placebo, when used as an adjunctive measure in relieving uncontrolled persistent chronic pain (not breakthrough pain) in participants with advanced cancer, who had inadequate analgesia even with optimized chronic opioid therapy. This multi-center study was conducted in two parts. All participants enrolled into the trial received nabiximols during one of two parts of the study, but they did not know which part. Eligible participants were not required to stop any of their current treatments or medications.

Timeline

Start: 2012-06-29
Primary completion: 2015-07-10
Completion: 2015-12-28

Outcome

Missed primary endpoint

registry analysis (superiority test); Double-blind Nabiximols vs Double-blind Placebo (GA-0034); p = 0.9173; Mean Difference (Final Values) -0.02 (95% CI -0.42 to 0.38); ANCOVA NCT01424566 ↗

Publications

Background Fallon MT, Albert Lux E, McQuade R, Rossetti S, Sanchez R, Sun W, Wright S, Lichtman AH, Kornyeyeva E. Sativex oromucosal spray as adjunctive therapy in advanced cancer patients with chronic pain unalleviated by optimized opioid therapy: two double-blind, randomized, placebo-controlled phase 3 studies. Br J Pain. 2017 Aug;11(3):119-133. doi: 10.1177/2049463717710042. Epub 2017 May 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nabiximols	Other / unclassified	0.1 ml	Other

Indications

No indication recorded.