NCT00530764

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

A Double Blind, Randomized, Placebo Controlled, Parallel Group Dose-range Exploration Study of Sativex® in Relieving Pain in Patients With Advanced Cancer, Who Experience Inadequate Analgesia During Optimized Chronic Opioid Therapy.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (actual)
• Sponsor: GW Pharmaceuticals Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effective dose range and to demonstrate a non-effective dose range of Sativex in patients with advanced cancer, who experience inadequate pain relief even though they are on optimized chronic opioid therapy.

Conditions

• Palliative Care
• Pain
• Cancer

Interventions

Type	Name	Description
DRUG	Sativex Low Dose	Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
DRUG	Sativex Medium Dose	Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
DRUG	Sativex High Dose	Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2007-09-17
• Last updated: 2013-06-20
• Results posted: 2011-06-17

Locations

110 sites across 16 countries: United States, Belgium, Canada, Chile, Czechia, Finland, France, Germany, India, Italy, Mexico, Poland, Romania, South Africa, Spain, United Kingdom