A Study of Sativex® for Pain Relief in Patients With Advanced Malignancy

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.