At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 246 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/NCT00710554

NCT00710554Phase 3Completed

Compare CT.gov

A Double Blind, Randomized, Placebo Controlled, Parallel Group Study of Sativex® in the Treatment of Subjects With Peripheral Neuropathic Pain, Associated With Allodynia

Jazz Pharmaceuticals·interventional·Posted Jul 4, 2008·Updated May 3, 2023

In Brief

A Phase 3 clinical trial evaluating Sativex and Placebo for Pain and Peripheral Neuropathy. Completed, enrolled 246 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

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartAug 2005

Primary CompletionOct 2006

First PostedJul 2008

TodayJul 2026

First PostedJul 4, 2008

Enrollment StartAug 1, 2005

Primary CompletionOct 1, 2006

TodayJul 2, 2026

Enrollment to primary: 1.2 yearsPosted 18.0 years ago

Interventions

Sativexdrug

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.