A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy
Condition: Palliative Care; Pain; Cancer
Intervention: Placebo; Sativex®; THC Alone
Intervention description: Containing colourants and excipients. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations in 24 hours.; Containing D9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours.; Containing THC, 27 mg/ml, as extract of Cannabis sativa L. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg) in 24 hours.
Intervention MeSH terms: Nabiximols
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 177.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Palliative Care; Pain; Cancer

Summary:

      The purpose of this study is to determine whether Sativex® and GW-2000-02 are effective in
      the management of subjects with intractable cancer-related pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to give informed consent.

          -  Male or female, age 18 years or above.

          -  Diagnosed with cancer of any type, which is considered to be terminal.

          -  Diagnosed with cancer-related pain which is not wholly alleviated with their current
             strong opioid treatment and whose level of pain measured on a NRS is ³four on at least
             one occasion per day, during the two day run-in period, leading up to visit 1.

          -  On strong opioid maintenance therapy for at least seven days prior to the screening
             visit.

          -  Willing to abstain from any use of cannabis during the study, other than the study
             medication.

          -  No cannabinoids use (cannabis, Marinol® or Nabilone) for at least seven days before
             Visit 1 and willing to abstain from any use of cannabis during the study.

          -  Clinically acceptable blood results at the screening visit.

          -  Able (in the investigators opinion) and willing to undertake and comply with all study
             requirements.

          -  Willing to allow their own general practitioner, and consultant if appropriate, to be
             informed of study participation.

          -  Willing for the Home Office to be notified of his or her participation in the study
             (applicable to the UK centres only).

        Exclusion Criteria:

          -  Know history of substance misuse.

          -  Known or suspected to have had an adverse reaction to cannabinoids causing psychosis
             or other severe psychiatric illness.

          -  Received any epidural analgesia within 48 hours prior to study entry.

          -  Either received, within two weeks of study entry, or due to receive chemotherapy or
             radiotherapy during the study.

          -  Unable to give informed consent.

          -  History of any type of schizophrenia, any other psychotic illness, a serious
             personality disorder, or other significant psychiatric illness other than depression
             associated with their chronic pain and/or in response to the underlying condition.

          -  Currently taking levodopa (Sinemet®, Sinemet plus®, Levodopa®, L-dopa®, Madopar®,
             Benserazide®).

          -  Had a serious cardiovascular disorder, including angina, uncontrolled hypertension, or
             an uncontrolled symptomatic cardiac arrhythmia.

          -  Significant renal or hepatic impairment, who in the opinion of the investigator, were
             unsuitable for treatment with study medication.

          -  History of epilepsy.

          -  Had oral cavity cancers or whose previous treatments had included radiotherapy to the
             floor of the mouth.

          -  Female subjects who were pregnant or lactating or of child-bearing potential and were
             inadequately protected against conception during the study and for three months
             thereafter.

          -  Male subjects who were sexually active and who were not using adequate forms of
             contraception during the study and for three months thereafter.

          -  Subjects who had participated in a clinical research study in the past four weeks,
             prior to study entry.

          -  Planned travel outside the UK during the study (applicable to the UK centres only).

          -  Subjects who, in the opinion of the investigator, were unsuitable to participate in
             the study for any other reason, not mentioned in the entry criteria.