Open Label Study of Sativex for the Treatment of Cancer Related Pai

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 976

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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 488
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 488

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 the ‘End of Treatment’ Visit of the parent study (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 the parent study ‘End of Treatment’ Visit laboratory results are available; patients that entered the study and are later found not to meet this criterion should be withdrawn from the study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).;Timepoint(s) of evaluation of this end point: End of Treatment Visit

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The following are the study secondary endpoints: • Columbia Suicide Severity Rating Scale (C-SSRS). • Vital Signs. • Hematology and Biochemistry Assessments. • Weekly average NRS Pain. • Weekly average Sleep Disruption NRS. • Constipation NRS. • Patient Satisfaction Questionnaire (PSQ).;Timepoint(s) of evaluation of this end point: 'End of Treatment Visit' for Visit Assessments. Diary data will be submitted across time/visits

A multicenter, non-comparative, open-label extension study to assess the long term safety of Sativex oromucosal spray (Sativex®; Nabiximols) as adjunctive therapy in patients with uncontrolled persistent chronic cancer related pain.

GW Pharma Ltd

Updated 10/9/2012