Spots Global Cancer Trial Database for Study to Compare the Safety and Tolerability of Sativex® in Patients With Cancer Related Pain

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Trial Identification

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

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

Study ID: NCT00675948

Conditions

Pain

Cancer

Interventions

Sativex

GW-2000-02

Study Description

Brief 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.