Sativex® for Relieving Persistent Pain in Patients With Advanced Cancer (SPRAY III)

• Change from baseline in mean NRS average pain [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
• Change from baseline in mean NRS worst pain [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
• Change from baseline in mean Sleep Disruption NRS [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

This nine week study will aim to determine the efficacy, safety and tolerability of Sativex® as an adjunctive treatment, compared with placebo in relieving uncontrolled persistent chronic pain in patients with advance cancer.

Eligible patients will not be required to stop any of their current treatments or medications.

• Pain
• Advanced Cancer

• Drug: Sativex®
  Administered orally with a spray into cheek (100 μl oromucosal spray administered twice daily up to a maximum of 10 sprays per day)
  Other Name: Nabiximols
• Drug: Placebo (GA-0034)
  Administered orally with a spray into cheek

• Placebo Comparator: Placebo (GA-0034)
  Patients will be randomized to receive either Sativex® or placebo using a 1:1 allocation ratio.
  Intervention: Drug: Placebo (GA-0034)
• Experimental: Sativex®
  Patients will be randomized to receive either Sativex® or placebo using a 1:1 allocation ratio.
  Intervention: Drug: Sativex®

Inclusion Criteria:

• The patient has advanced cancer for which there is no known curative therapy
• The patient has a clinical diagnosis of cancer related pain, which is not alleviated with their current optimized opioid treatment
• The patient is receiving an optimized maintenance dose of Step III 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 patient is receiving a daily maintenance dose Step III 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 patient is using no more than one type of break-through opioid analgesia

Exclusion Criteria (abbreviated):

• Have any planned clinical interventions that would affect their pain (e.g., chemotherapy or radiation therapy where, in the clinical judgment of the investigator, these would be expected to affect pain)
• The patient is currently using or has used cannabis or cannabinoid based medications within 30 days of study entry and is unwilling to abstain for the duration of the study
• Has experienced myocardial infarction or clinically significant cardiac dysfunction within the last 12 months or has a cardiac disorder that, in the opinion of the investigator would put the patient at risk of a clinically significant arrhythmia or myocardial infarction
• Has significantly impaired renal function
• Has significantly impaired hepatic function
• Female patients of child-bearing potential and male patients whose partner is of child-bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (however, a male condom should not be used in conjunction with a female condom as this may not prove effective)