NCT00674609

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

A Double Blind, Randomized, Parallel Group, Placebo Controlled, Comparative Study of the Efficacy, Safety and Tolerability of Cannabis Based Medicine (CBM) Extracts in Patients With Cancer-related Pain.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 177 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Sativex® and GW-2000-02 are effective in the management of subjects with intractable cancer-related pain.

Detailed description

This is a two week (two days baseline and two weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex® and GW-2000-02 in subjects with cancer-related pain. Subjects are screened to determine eligibility and completed a two-day baseline period. Subjects then return to the centre for assessment, randomisation and dose introduction. All subjects are allowed to continue using all their current medications, provided that the dose remains stable throughout the study period. Their progress is reviewed after seven to 10 days and at the end of the study (day 14 to 20), or upon withdrawal. Subjects in this study are given the opportunity to be enrolled in an open label extension study (GWEXT0101).

Conditions

• Palliative Care
• Pain
• Cancer

Interventions

Type	Name	Description
DRUG	Placebo	Containing colourants and excipients. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations in 24 hours.
DRUG	Sativex®	Containing D9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours.
DRUG	THC Alone	Containing THC, 27 mg/ml, as extract of Cannabis sativa L. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg) in 24 hours.

Timeline

• Start date: 2002-02-01
• Primary completion: 2004-02-01
• Completion: 2004-03-01
• First posted: 2008-05-08
• Last updated: 2023-05-03
• Results posted: 2012-08-13

Locations

1 site across 1 country: United Kingdom