CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 19 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/NCT00713817
NCT00713817Phase 3Completed
CompareCT.gov

A Multicentre, Open Label, Follow on Study to Assess the Maintenance of Effect, Tolerance and Safety of Sativex® in the Treatment of Subjects With Neuropathic Pain. This Will be Followed by a Randomised-withdrawal Phase (Part B) for a Subset of Patients

Jazz Pharmaceuticals·interventional·Posted Jul 11, 2008·Updated May 3, 2023

In Brief

A Phase 3 clinical trial evaluating Sativex® and Placebo for Pain and Peripheral Neuropathy. Completed, enrolled 19 participants across 1 site.

Detailed Summary

The purpose of this study is to assess the maintenance of effect after long-term treatment of Sativex® in subjects with neuropathic pain.

Study Details

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

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 11, 2008
Enrollment StartMar 1, 2007
Primary CompletionJul 1, 2007
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 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%) flavoring. 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