Pain in patients with advanced cancer who experience inadequate analgesia during optimized chronic opioid therapy. MedDRA version: 13.1 Level: PT Classification code 10058019 Term: Cancer pain System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Sativex Oromucosal Spray
Product Name: Sativex
Product Code: GW-1000-02
Pharmaceutical Form: Oromucosal spray
CAS Number: 1972-08-3
Other descriptive name: delta-9-tetrahydrocannabinol
Con
Sponsors
GW Pharma Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion: Patients meeting the following criteria will be considered eligible for this study: •Has completed the parent study within the last seven days. •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: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion: The patient may not enter the study if ANY of the following apply: •The patient is currently using cannabis or cannabinoid based medications, other than the parent study IMP, 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). •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. •Female patient of child-bearing potential or male patient 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. •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. •Has significantly impaired hepatic function at Visit 4 (ALT >5X upper limit of normal (ULN) or bilirubin (TBL) > 2X ULN). If the ALT or AST >3xULN and (TBL >2xULN or INR >1.5) this patient should not enter the study. This criterion can only be confirmed once Visit 4 laboratory results are available; patients that entered the study and are later found not to meet this criterion should be withdrawn from the study. If the parent study Visit 4 laboratory results raise any safety concerns, the investigator should consider whether it will be appropriate for the patient to continue to participate in the extension study, or if the patient should be withdrawn.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of long-term Sativex therapy when used as an adjunctive (not breakthrough) measure in patients with advanced cancer.;Secondary Objective: To assess the maintenance of effect through long-term usage of Sativex as adjunctive therapy for the relief of uncontrolled persistent chronic cancer related pain.;Primary end point(s): The primary endpoint is the incidence of adverse events (AEs). | — |
Countries
Belgium, Bulgaria, Czech Republic, Estonia, Germany, Hungary, Italy, Latvia, Lithuania, Poland, Spain, United Kingdom
Outcome results
None listed