Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer

Phase 3 Completed 399 enrolled Jazz Pharmaceuticals Otsuka Pharmaceutical Development & Commercialization, Inc. · collab

RandomizedParallel-groupTriple-blindTreatment

Summary

This 9-week study aimed to determine the efficacy, safety, and tolerability of nabiximols (Sativex®) as an adjunctive treatment, compared with placebo in relieving uncontrolled persistent chronic pain in participants with advanced cancer. Eligible participants were not required to stop any of their current treatments or medications.

Timeline

Start: 2011-05-27
Primary completion: 2014-11-24
Completion: 2014-11-24

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.