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A Study of Sativex® for Pain Relief Due to Diabetic Neuropathy

Pain Clinical Trial

Official title:
A Double Blind, Randomized, Placebo Controlled, Parallel Group Study of Sativex in the Treatment of Subjects With Pain Due to Diabetic Neuropathy

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in relieving pain due to Diabetic Neuropathy.

Clinical Trial Description

This was a 15 week (one week baseline and fourteen weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex in subjects with pain due to diabetic neuropathy. Subjects were screened to determine eligibility and completed a seven-day baseline period. Subjects then returned to the centre for assessment, randomisation and dose introduction. Visits occurred at the end of weeks two, six, ten and at the end of the study (treatment week 14) or earlier if they withdrew. A follow up visit occurred 28 days after completion or withdrawal. Subjects in this study were given the opportunity to be enrolled in an open label extension study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00710424
Study type Interventional
Source Jazz Pharmaceuticals
Contact
Status Completed
Phase Phase 3
Start date July 2005
Completion date June 2006
View Details
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