Long Term Safety of Sativex Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pain
Condition: Pain; Advanced Cancer
MeSH terms: Cancer Pain
Intervention: Nabiximols
Intervention MeSH terms: Nabiximols
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 660.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cancer pain; Opioid therapy; Inadequate analgesia; Optimized chronic opioid therapy

Summary:

      This was a six-month open-label extension (OLE) study to evaluate the safety of long-term
      nabiximols (Sativex®) therapy when used as an adjunctive treatment in participants with
      advanced cancer. The study provided continued availability of nabiximols to participants who
      completed a preceding Phase 3 study and new (de novo) participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant had completed the parent study within the last seven days

          -  Willing and able to give written informed consent

          -  Willing and able to comply with all study requirements

        Exclusion Criteria:

          -  The participant was using cannabis or cannabinoid based medications, other than the
             parent study investigational medicinal product (IMP), and was unwilling to abstain for
             the duration of the study

          -  Any history or immediate family history of schizophrenia, other psychotic illness,
             severe personality disorder or other significant psychiatric disorder other than
             depression associated with their underlying condition

          -  Any known or suspected history of a substance abuse/dependence disorder (including
             opiate abuse/dependence prior to the diagnosis of cancer), current heavy alcohol
             consumption (more than 60 grams [g] of pure alcohol per day for men, and more than 40
             g of pure alcohol per day for women), current use of an illicit drug or current
             non-prescribed use of any prescription drug

          -  Had poorly controlled epilepsy or recurrent seizures (for example, one or more seizure
             during the last year)

          -  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 at the "end of treatment" visit of the
             parent study

          -  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 should not have been used in conjunction with a female condom as this may not
             have proven effective)