A Two-Part Study of Sativex® Oromucosal Spray for Relieving Uncontrolled Persistent Pain in Patients 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: 406.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer pain; Opioid therapy; Inadequate analgesia; Optimized chronic opioid therapy

Summary:

      The primary objective of this study was to evaluate the efficacy of nabiximols (Sativex®),
      compared with placebo, when used as an adjunctive measure in relieving uncontrolled
      persistent chronic pain (not breakthrough pain) in participants with advanced cancer, who had
      inadequate analgesia even with optimized chronic opioid therapy.

      This multi-center study was conducted in two parts. All participants enrolled into the trial
      received nabiximols during one of two parts of the study, but they did not know which part.

      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 is no known curative therapy

          -  The participant had a clinical diagnosis of cancer related pain, which was not
             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):

          -  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 currently using or had used cannabis or cannabinoid-based
             medications within 30 days of study entry and was unwilling to abstain for the
             duration of the study

          -  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

          -  Had significantly impaired renal function

          -  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 three months thereafter (however, a
             male condom was not to be used in conjunction with a female condom as this may not
             have proven effective)