Sativex® for Relieving Persistent Pain in Participants With Advanced Cancer

Phase 3 Completed 397 enrolled GW Pharmaceuticals Ltd 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: 2010-11-25
Primary completion: 2015-07-02
Completion: 2015-07-02

Outcome

Missed primary endpoint

registry analysis (superiority test); Nabiximols vs Placebo (GA-0034); p = 0.0854 NCT01262651 ↗

Publications

Background Lichtman AH, Lux EA, McQuade R, Rossetti S, Sanchez R, Sun W, Wright S, Kornyeyeva E, Fallon MT. Results of a Double-Blind, Randomized, Placebo-Controlled Study of Nabiximols Oromucosal Spray as an Adjunctive Therapy in Advanced Cancer Patients with Chronic Uncontrolled Pain. J Pain Symptom Manage. 2018 Feb;55(2):179-188.e1. doi: 10.1016/j.jpainsymman.2017.09.001. Epub 2017 Sep 18.

Drugs

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

Indications

No indication recorded.