ong Term Safety of Sativex® Oromucosal Spray (Sativex®; Nabiximols) as Adjunctive Therapy in Patients With Uncontrolled Persistent Chronic Cancer Related Pai
- Conditions
- Health Condition 1: null- patients with uncontrolled persistent chronic cancer related pain
- Registration Number
- CTRI/2012/12/003169
- Lead Sponsor
- GW Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 800
1. Patient has completed the parent study within the last seven days
2. Willing and able to give written informed consent
3. Willing and able to comply with all study requirements
1. 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
2. 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
3. Any known or suspected history of a substance abuse/dependence disorder (including opiate abuse/dependence prior to the diagnosis of cancer)
4. Has poorly controlled epilepsy or recurrent seizures (i.e. one or more seizure during the last year)
5. 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
6. Has significantly impaired renal function
7. Has significantly impaired hepatic function
8. 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse events (AEs)Timepoint: Incidence of adverse events (AEs)
- Secondary Outcome Measures
Name Time Method Columbia Suicide Severity Rating Scale (C-SSRS)Timepoint: Time Frame: 6 months;Constipation NRSTimepoint: Time Frame: 6 months;Hematology and Biochemistry AssessmentsTimepoint: Time Frame: 6 months;Patient Satisfaction Questionnaire (PSQ)Timepoint: Time Frame: 6 months;Vital SignsTimepoint: Time Frame: 6 months;Weekly average NRS PainTimepoint: Time Frame: 6 months;Weekly average Sleep Disruption NRSTimepoint: Time Frame: 6 months