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. - ND

• Conditions: PAIN IN PATIENTS WITH ADVANCED CANCER, WHO EXPERIENCE INADEQUATE ANALGESIA DURING OPTIMIZED CHRONIC OPIOID THERAPY; MedDRA version: 9.1Level: LLTClassification code 10058019Term: Cancer pain

• Registration Number: EUCTR2007-005225-30-IT
• Lead Sponsor: GW PHARMA LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-07
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 336

Inclusion Criteria

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 must meet at least one of the following two criteria in order to be eligible for the study; 1. The SR fixed dose opioid therapy must be at least at an equianalgesic daily dose to 120 mg of oral morphine and the patient is not expected to gain further therapeutic benefit by increasing the dose of the SR opioid therapy any further. 2. They are currently or have previously experienced intolerable side effects caused by the opioid analgesia, which has prevented them from increasing the dose of opioid therapy any further. All of the following criteria must be met on the same three consecutive days during the baseline period in order to be eligible for randomization: 1. The patient is receiving no more than an average of 4 doses of opioid break-through analgesia (IR) per day. N.B., The opioid break-through analgesia must be Step III according to the WHO analgesic ladder. 2. The patient has not altered their SR fixed dose opioid therapy. 3. The level of pain is 4 and ≤8 on an 11-point NRS for three consecutive days, when the patient is asked the following question: ?On a scale of ?0 to 10?, please rate your pain by indicating the number that best describes your pain on average in the last 24 hours? where: 0 = ?no pain? and 10 = ?Pain as bad as you can imagine? 4. The 11-point NRS does not change by more than two points over the three consecutive days (i.e., no more than two points between the highest and lowest scores). 5. The patient is not experiencing intolerable side effects. 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 has satisfactorily completed the IVRS.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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. The patient is currently using two or more types of break-through opioid analgesia (IR). The patient is currently receiving a prohibited medication and unwilling to stop or comply for the duration of the study. The patient is currently using or has used cannabis or cannabinoid based medications or Acomplia [Rimonabant] within 30 days of study entry and 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 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). Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the IP. 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. The patient has a QT interval of > 450 ms (males) or > 470 ms (females) at Visit 1. The patient has a secondary or tertiary atrioventricular (AV) block or sinus bradycardia (HR <50bpm unless physiological) or sinus tachycardia (HR>110bpm) at Visit 1. The patient has a diastolic blood pressure of <50 mmHg or >105 mmHg (when measured in a sitting position at rest for 5 minutes) prior to randomization. The patient has impaired renal function e.g. creatinine clearance is lower than 50 ml/min at Visit 1 and is indicative of renal impairment. The patient has significantly impaired hepatic function at Visit 1 (ALT >5X Upper limit of normal (ULN) or bilirubin > 2X ULN). 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 during the study and for three months thereafter. Female patient who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter. Patients who have received an IP within the 12 weeks before Visit 1. 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. Following a physical exam, the patient has any abnormalities that, in the opinion of the investigator, would prevent them from safely participating in the study. Unwilling to abstain from donation of blood during the study. Travel outside the country of residence planned during the study. Patients previously randomized into this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified