Health Condition 1: null- patients with advanced cancer, who have inadequate analgesia even with optimized chronic opioid therapy
Conditions
Interventions
Intervention1: N/A: N/A
Intervention2: Sativex oromucosal spray: Oromucosal spray, containing THC (27 mg/mL): CBD (25 mg/mL), in ethanol: propylene glycol (50:50) excipients, with peppermint oil (0.05
Sponsors
GW Pharmaceuticals Ltd
Otsuka Pharmaceutical Development Commercialization Inc
Pharmaceutical Research Associates India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient has advanced cancer for which there is no known curative therapy. 2. The patient has a clinical diagnosis of cancer related pain, which is not alleviated with their current optimized opioid treatment 3. 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 4. 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 break-through opioids) 5. The patient is using no more than one type of break-through opioid analgesia
Exclusion criteria
Exclusion criteria: 1. 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) 2. 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 3. 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 4.Has significantly impaired renal function 5. Has significantly impaired hepatic function 6. 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean 11-point NRS average pain score over the last four days of the Part B treatment period (end of treatment) taken from the IVRSTimepoint: Mean 11-point NRS average pain score over the last four days of the Part B treatment period (end of treatment) taken from the IVRS | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean 11-point NRS worst pain score from baseline to the end of treatmentTimepoint: Time Frame: 7 weeks;Mean sleep disruption NRS score from baseline to the end of treatmentTimepoint: Time Frame: 7 weeks;Percentage improvement in NRS average pain score from baseline to the end of treatmentTimepoint: Time Frame: 7 weeks | — |
Countries
Australia, India, Israel, Italy, Republic of Korea, Spain, Taiwan, United States of America
Contacts
Public ContactTarun Pandotra
PRA International
Outcome results
None listed