CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 125 enrolled
Drug / intervention
Sativex® +1 moredrug
Likely dose
Sativex® 27 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00711880
NCT00711880Phase 3Completed
CompareCT.gov

A Double Blind, Randomised, Placebo Controlled Parallel Group Study of Cannabis Based Medicine Extract (CBME), in the Treatment of Peripheral Neuropathic Pain Characterised by Allodynia.

Jazz Pharmaceuticals·interventional·Posted Jul 9, 2008·Updated Apr 12, 2023

In Brief

A Phase 3 clinical trial evaluating Sativex® and Placebo for Pain and Peripheral Neuropathy. Completed, enrolled 125 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in relieving peripheral neuropathic pain associated with allodynia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Peripheral Neuropathy
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 9, 2008
Enrollment StartMay 1, 2002
Primary CompletionMar 1, 2004
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.0 years ago

Interventions

Sativex®drug

containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours

Placebodrug

containing peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient.