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.
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).
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
The Change in Mean Pain Numerical Rating Scale (NRS) Score From Baseline to the End of the Treatment.
The pain NRS was complete at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. No pain relates to the time prior to the onset of pain due to cancer. A negative value indicates an improvement in pain score from baseline.
2 weeks: baseline - end of week 2 (last 3 days of treatment)
Jeremy R Johnson, MB ChB
Shropshire and Mid-Wales Hospice
United Kingdom: Medicines and Healthcare Products Regulatory Agency