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.
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.
