A double blind, randomised, placebo controlled, parallel group study of Sativex in the treratment of subjects with pain due to diabetic neuropathy - N/A

GW Pharma Ltd0 sites218 target enrollmentFebruary 23, 2005

Overview

No summary available.

Registry

who.int

Start Date

February 23, 2005

End Date

July 8, 2006

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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

•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