Study of Sativex for the Treatment of Cancer Related Pain.

Conditions: Pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.
MedDRA version: 14.1Level: PTClassification code 10058019Term: Cancer painSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2009-016065-29-HU

Lead Sponsor: GW Pharma Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 380

Inclusion Criteria

For inclusion in the study patients must fulfill ALL of the following criteria:
• Patient is aged 18 years or above.
• The patient has advanced cancer.
• The patient has a clinical diagnosis of cancer related pain, which is not wholly alleviated with their current optimized opioid treatment.
• The patient is receiving an optimized maintenance dose of Step III opioid therapy, preferably with a sustained release preparation, but also allowing a regular maintenance dose of around the clock use of immediate release preparations.
• The patient is receiving a daily maintenance dose Step III opioid therapy of less than or equal to a total daily opioid dose of 500 mg/day of morphine equivalence (including maintenance and/or break-through opioids).
• The patient is using no more than one type of break-through opioid analgesia.
• The patient is willing to continue to take their maintenance opioid therapy at the same daily dose, throughout the duration of the study where possible.
• Has satisfactorily completed the IVRS and willing to continue to do so.
• Willing and able to give written informed consent.
• Willing and able to comply with all study requirements.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 190
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 190

Exclusion Criteria

Exclusion: The patient may not enter the study if ANY of the following apply:
• Have any planned clinical interventions that would affect their pain (e.g., chemotherapy or radiation therapy where, in the clinical judgment of the investigator, these would be expected to affect pain).
• The patient is currently using or has used cannabis or cannabinoid based medications within 30 days of study entry and is 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 60g of pure alcohol per day for men, and more than 40g of pure alcohol per day for women), current use of an illicit drug or current non
prescribed use of any prescription drug.
• Has poorly controlled epilepsy or recurrent seizures (i.e. one or more seizure during the last year).
• Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IMP.
• Has experienced myocardial infarction or clinically significant 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 significant arrhythmia or myocardial infarction.
• Has significantly impaired renal function as evidenced by a creatinine clearance lower than 40 mL/min at Visit 1.
• Has significantly impaired hepatic function at Visit 1
• Female patients of child-bearing potential and male patients whose partner is of child-bearing potential, unless willing to ensure that they or their partner use effective contraception, for example, oral contraception, double barrier, intra-uterine device, during the study and for three months thereafter (however, a male condom should not be used in conjunction with a female condom as this may not prove effective).
• Female patient who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
• Patients who have received a non-approved Investigational Product within 30 days of Visit 1.
• Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the result of the study, or the patient’s ability to participate in the study.
• Travel outside the country of residence planned during the study.
• Patients previously randomized into this study or any other Sativex clinical trial for Cancer Pain.