A double blind, randomized, placebo controlled, parallel group dose-range exploration study of Sativex® in relieving pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.
- The patient has advanced active cancer for which there is no known curative therapy.
- The patient is able (in the investigators opinion) and willing to comply with all study requirements.
- The patient has a clinical diagnosis of cancer related pain, which is not wholly alleviated with their current opioid treatment.
- The patient is receiving a sustained release (SR) fixed dose of opioid therapy (excluding Methadone). N.B. The opiate therapy must be Step III according to the WHO analgesic ladder.
- The patient is willing to continue to take their regular daily baseline opioid regimen (SR) at the same dose, throughout the duration of study.
- The patient should be excluded from entering study if they have received or are due to receive during the study period; chemotherapy, hormone therapy or radiotherapy, which, in the opinion of the investigator will affect their pain.
- 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 diagnosed dependence disorder, current heavy alcohol consumption, current use of an illicit drug or current non prescribed use of any prescription drug.
- The patient has poorly controlled epilepsy or recurrent seizures (i.e. at least one year since last seizure).
- The patient has experienced myocardial infarction or clinically relevant 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 relevant arrhythmia or myocardial infarction.
- Cumulative average pain response curves
- Mean daily IVRS NRS pain score (average and also worst pain).
- Brief Pain Inventory - Short Form
- Sleep Disruption NRS
- Patient Assessment of Constipation Quality of Life (PAC-QoL)
- Patient Global Impression of Change - PGIC
- Montgomery Asberg Depression Rating Scale (MADRS)
- Addiction Research Center Inventory (ARCI)
This nine week (5 to 14 day baseline and five weeks treatment period, followed by a two week follow up visit), multi-center, double blind, randomized, placebo controlled, dose ranging study will aim to determine the effective dose range and to demonstrate a non-effective dose range of Sativex in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy. The study will include a five-week double blind treatment period incorporating one week of titration after which patients will remain on a stable dose of treatment where possible. The primary endpoint is the patient 30% pain response status, where a response is defined as a 30% or greater reduction in the IVRS 11- point Numeric Rating Scale pain score (average pain). Globally 336 patients are planned to be enrolled in this study. From India,approximately 60 patients are planned to be enrolled. The anticipated date of first patient enrollement in India can be October 12, 2009. As of July 30, 2009, 219 patients have been enrolled and 145 patients have completed the study.