A clinical trial to study the effective dose range of the study drug, Sativex, in patients with advanced cancer who experience inadequate pain relief during optimized chronic opioid therapy.
- Conditions
- Health Condition 1: null- Cancer painHealth Condition 2: G893- Neoplasm related pain (acute) (chronic)
- Registration Number
- CTRI/2009/091/000336
- Lead Sponsor
- GW Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 336
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).Timepoint: During conduct of the study
- Secondary Outcome Measures
Name Time Method - Cumulative average pain response curves <br/ ><br>- Mean daily IVRS NRS pain score (average and also worst pain). <br/ ><br>- Brief Pain Inventory - Short Form <br/ ><br>- Sleep Disruption NRS <br/ ><br>- Patient Assessment of Constipation Quality of Life (PAC-QoL) <br/ ><br>- Patient Global Impression of Change - PGIC <br/ ><br>- Montgomery Asberg Depression Rating Scale (MADRS) <br/ ><br>- Addiction Research Center Inventory (ARCI)Timepoint: During conduct of the study