Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer

• Status: Completed
• Trial end date: 2014-11-24
• Target enrollment: 0
• Participant gender: All

Summary

This 9-week study aimed to determine the efficacy, safety, and tolerability of nabiximols (Sativex®) as an adjunctive treatment, compared with placebo in relieving uncontrolled persistent chronic pain in participants with advanced cancer.

Eligible participants were not required to stop any of their current treatments or medications.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GW Pharmaceuticals Ltd.
• Collaborator: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Analgesics, Opioid; Nabiximols

Criteria

Inclusion Criteria (abbreviated):

• The participant had advanced cancer for which there was no known curative therapy

• The participant had a clinical diagnosis of cancer related pain, which was not wholly alleviated with their current optimized opioid treatment

• The participant received an optimized maintenance dose of Step 3 opioid therapy, preferably with a sustained release preparation, but also allowing a regular maintenance dose of around-the-clock use of immediate release preparations

• The participant received a daily maintenance dose Step 3 opioid therapy of less than or equal to a total daily opioid dose of 500 mg/day of morphine equivalence (including maintenance and break-through opioids)

• The participant was using no more than one type of break-through opioid analgesia

Exclusion Criteria (abbreviated):

• The participant had any planned clinical interventions that would have affected their pain (for example, chemotherapy or radiation therapy where, in the clinical judgment of the investigator, these would be expected to affect pain)

• The participant was using or had used cannabis or cannabinoid-based medications within 30 days of study entry and is unwilling to abstain for the duration of the study

• The participant had experienced myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or had a cardiac disorder that, in the opinion of the investigator, would have put the participant at risk of a clinically significant arrhythmia or myocardial infarction

• The participant had significantly impaired renal function

• The participant had significantly impaired hepatic function

• Female participants of child-bearing potential and male participants whose partner was of child-bearing potential, unless willing to ensure that they or their partner used effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for 3 months thereafter (however, a male condom was not to be used in conjunction with a female condom as this may not have proven effective)