Primary Outcome Measures:
- Assessment of long term safety and tolerability of Sativex and GW-2000-02 in subjects with cancer related pain by monitoring the number, frequency and type of adverse events reported by subjects. [ Time Frame: 7-10 days after Visit 1 and then every four weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Laboratory parameters pre and post-treatment [ Time Frame: Every four weeks ] [ Designated as safety issue: No ]
- Use of rescue medication [ Time Frame: 7-10 days after Visit 1 and then every four weeks ] [ Designated as safety issue: No ]
- Use of maintenance analgesic medication [ Time Frame: 7-10 days after Visit 1 and then every four weeks ] [ Designated as safety issue: No ]
- Pain severity 0-10 NRS [ Time Frame: 7-10 days after Visit 1 and then every four weeks ] [ Designated as safety issue: No ]
- Health 0-10 NRS [ Time Frame: 7-10 days after Visit 1 and then every four weeks ] [ Designated as safety issue: No ]
- EORTC quality of life questionnaire [ Time Frame: 7-10 days after Visit 1 and then every four weeks ] [ Designated as safety issue: No ]
- Brief Pain Inventory Short Form [ Time Frame: 7-10 days after Visit 1 and then every four weeks ] [ Designated as safety issue: No ]
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® and GW-2000-02 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.