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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

Inclusion Criteria

For inclusion in the study patients must fulfill ALL of the following criteria:
- Patient 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 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 400

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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