An Open-label, Extension Study, to Investigate the Long-term Safety and Tolerability of Cannabis Based Medicine Extracts in Patients With Cancer-related Pain.
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.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
The Incidence of Adverse Events as a Measure of Subject Safety
The number of subjects who experienced an adverse event in this study is presented.
0 - 657 days
Jeremy R Johnson, MB ChB
Shropshire and Mid-Wales Hospice
United Kingdom: Medicines and Healthcare Products Regulatory Agency