At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 297 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/NCT00710424

NCT00710424Phase 3Completed

Compare CT.gov

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

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 Diabetic Neuropathy. Completed, enrolled 297 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPain, Diabetic Neuropathy

CountriesUnited Kingdom

Collaborators--

Timeline

Phase 3CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJul 2005

Primary CompletionJun 2006

First PostedJul 2008

TodayJul 2026

First PostedJul 4, 2008

Enrollment StartJul 1, 2005

Primary CompletionJun 1, 2006

TodayJul 2, 2026

Enrollment to primary: 11 monthsPosted 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.