A Two-Part Study of Sativex® Oromucosal Spray for Relieving Uncontrolled Persistent Pain in Patients With Advanced Cancer
Status:
Completed
Trial end date:
2015-12-28
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
GW Pharmaceuticals Ltd.
Collaborator:
Otsuka Pharmaceutical Development & Commercialization, Inc.