A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy.
Condition: Palliative Care; Pain; Cancer
Intervention: Sativex Low Dose; Sativex Medium Dose; Sativex High Dose
Intervention description: Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.; Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.; Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
Intervention MeSH terms: Nabiximols; Dronabinol; Cannabidiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 360.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain; Cancer; Palliative

Summary:

      The purpose of this study is to determine the effective dose range and to demonstrate a
      non-effective dose range of Sativex in patients with advanced cancer, who experience
      inadequate pain relief even though they are on optimized chronic opioid therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has advanced active cancer for which there is no known curative therapy.

          -  The patient is able (in the investigators opinion) and willing to comply with all
             study requirements.

          -  The patient has a clinical diagnosis of cancer related pain, which is not wholly
             alleviated with their current opioid treatment.

          -  The patient is receiving a sustained release (SR) fixed dose of opioid therapy
             (excluding Methadone). N.B. The opiate therapy must be Step III according to the World
             Health Organization (WHO) analgesic ladder.

          -  The patient is willing to continue to take their regular daily baseline opioid regimen
             (SR) at the same dose, throughout the duration of study.

        Exclusion Criteria:

          -  The patient should be excluded from entering study if they have received or are due to
             receive during the study period; chemotherapy, hormone therapy or radiotherapy, which,
             in the opinion of the investigator will affect their pain.

          -  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 diagnosed dependence disorder, current heavy
             alcohol consumption, current use of an illicit drug or current non prescribed use of
             any prescription drug.

          -  The patient has poorly controlled epilepsy or recurrent seizures (i.e. at least one
             year since last seizure).

          -  The patient has experienced myocardial infarction or clinically relevant 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 relevant arrhythmia
             or myocardial infarction.