A double blind, randomised, placebo controlled, parallel group study of Sativex in the treratment of subjects with pain due to diabetic neuropathy - N/A
- Conditions
- Painful diabetic neuropathy
- Registration Number
- EUCTR2004-002530-20-GB
- Lead Sponsor
- GW Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 218
1. Subject is willing and able to give informed consent for participation in the study
2. Male or female, aged 18 years or above
3. Subject is able (in the investigators opinion) and willing to comply with all study requirements
4. Diagnosed with type 1 or 2 diabetes mellitus diagnosed according to the WHO criteria
5. Diagnosed with pain due to distal symmetrical diabetic neuropathy of at least 6 months duration, as defined by a NDS score of at least 6, and in whom pain is not wholly relieved with their current therapy
6. The last six daily diary NRS scores before randomisation have been completed by the subject and sum to at least 24
7. Subject has at least moderate pain due to diabetic neuropathy, which is defined as the total of the two NPS scores before randomisation being at least 80
8. Stable dose of regular pain medication and non-pharmacological therapies (including TENS) for at least 14 days prior to the screening visit and willing for these to be maintained throughout the study. Where patients are taking a medication containing paracetamol please refer to section 8.3 of the protocol
9. Willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable in individual countries
10. Willing to allow his or her general practitioner and consultant, if appropriate, to be notified of particpation in the study
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
1. Concomitant pain thought by the investigator to be of a nature or severity to interfere with the subject's assessment of their painful diabetic neuropathy
2. Subject has uncontrolled diabetes with HbA1c blood levels of more than 11% at Visit 1, Day B1
3. Currently receiving a prohibited medication and unwilling to stop or comply for the duration of the study
4. Currently using or has used cannabinoid based medications within 60 days of study entry and unwilling to abstain for the duration of the study
5. Currently using or has used cannabis within 30 days of study entry and unwilling to abstain for the duration of the study
6. Any history of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition
7. Any known or suspected history of alcohol or substance abuse;
8. Any history of epilepsy or recurrent seizures
9. Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medication
10. Subject has a postural drop of 20 mmHg or more in systolic blood pressure at screening
11. Subject has a medical history of gastroparesis
12. Subject has evidence of cardiomyopathy
13. Subject 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 subject at risk of a clinically relevant arrhythmia or myocardial infarction
14. Subject has a QT interval of > 450 ms (males) or > 470 ms (females) at Visit 1
15. Subject has a secondary or tertiary AV block or sinus bradycardia (HR < 50 bpm) or sinus tachycardia (HR > 110 bpm) at Visit 1
16. Subject has a diastolic blod pressure of < 50 mmHg or > 105 mmHg in a sitting position at rest for 5 minutes prior to randomisation
17. Subject has impaired renal function i.e. creatinine clearance is lower than 50ml/min at Visit 1
18. Subject has significantly impaired hepatic function, at Visit 1, in the investigator's opinion
19. Female subjects of child bearing potential and male subjects 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
20. Female subject who is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter
21. Subjects who have received an IMP within the 12 weeks before Visit 1
22. Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, may influence the result of the study, or the subject's ability to participate in the study
23. Following a physical exam, the subject has any abnormalities that, in the opinion of the investigator, would prevent the subject from safely participating in the study
24. Unwilling to abstain from donation of blood during the study
25. Travel outside the country of residence planned during the study
26. Subjects previously randomised into this study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of Sativex compared to placebo in relieving pain due to diabetic neuropathy;Secondary Objective: To evaluate the effect of Sativex compared with placebo on:<br>- secondary measures of pain relief<br>- sleep quality<br>- quality of life<br>To assess the safety and tolerability of Sativex;Primary end point(s): The mean 11-point numeric rating scale (NRS) diabetic neuropathy pain score during weeks 13 and 14 of treatment (end of treatment) taken from the daily diaries.<br>The variable for analysis will be the change in mean NRS from baseline to the end of the treatment.
- Secondary Outcome Measures
Name Time Method