NCT00675948

Study to Compare the Safety and Tolerability of Sativex® in Patients With Cancer Related Pain

An Open-label, Extension Study, to Investigate the Long-term Safety and Tolerability of Cannabis Based Medicine Extracts in Patients With Cancer-related Pain.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® and GW-2000-02.

Detailed description

Subjects who have previously participated in GWCA0101, 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® (containing delta-9-tetrahydrocannabinol \[THC\] and cannabidiol \[CBD\]) and GW-2000-02 (containing THC alone) in subjects with cancer-related pain are screened, and if eligible begin dosing with open-label Sativex®. They are allowed to self-titrate their study medication to symptom resolution or maximum tolerated/allowable dose of 130 mg THC and 120 mg CBD and have the opportunity to request a change from Sativex® to GW-2000-02 if they or the investigator consider their response less than optimal. Subjects are reviewed for tolerability and evidence of clinical benefit at 7-10 days after Visit 1 and then every four weeks. Continuation within the study is conditional on satisfactory reports of tolerability, efficacy and dosing regime.

Conditions

• Pain
• Cancer

Interventions

Type	Name	Description
DRUG	Sativex	Containing delta-9-tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml; both 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:CBD 120 mg) in 24 hours.
DRUG	GW-2000-02	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: 2002-04-01
• Primary completion: 2006-09-01
• Completion: 2006-09-01
• First posted: 2008-05-12
• Last updated: 2023-05-03
• Results posted: 2012-09-13

Locations

1 site across 1 country: United Kingdom