Sativex® for Relieving Persistent Pain in Participants With Advanced Cancer
Condition: Pain; Advanced Cancer
MeSH terms: Neoplasms
Intervention: Nabiximols; Placebo (GA-0034)
Intervention MeSH terms: Nabiximols
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 397.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer pain; Opioid therapy; Inadequate analgesia; Optimized chronic opioid therapy

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.
    

Eligibility 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)