At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 135 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/NCT00678795

NCT00678795Phase 3Completed

Compare CT.gov

A Double Blind, Randomised, Placebo Controlled, Parallel Group Study of Cannabis Based Medicine (CBM) Extract, in Patients Suffering Detrusor Overactivity Associated With Multiple Sclerosis.

Jazz Pharmaceuticals·interventional·Posted May 16, 2008·Updated May 3, 2023

In Brief

A Phase 3 clinical trial evaluating Sativex® and Placebo for Detrusor Overactivity and Multiple Sclerosis. Completed, enrolled 135 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in reducing the daily number of episodes on incontinence.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsDetrusor Overactivity, Multiple Sclerosis

CountriesUnited Kingdom

Collaborators--

Timeline

Phase 3CompletedFinished

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartAug 2002

Primary CompletionOct 2005

First PostedMay 2008

TodayJul 2026

First PostedMay 16, 2008

Enrollment StartAug 1, 2002

Primary CompletionOct 1, 2005

TodayJul 2, 2026

Enrollment to primary: 3.2 yearsPosted 18.1 years ago

Interventions

Sativex®drug

Containing ∆9 tetrahydrocannabinol (THC), 27 mg/ml and cannabidiol (CBD), 25 mg/ml as extract of Cannabis sativa L. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three-hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours

Placebodrug

containing excipients only. Subjects received study medication delivered in 100 µl actuations from a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three-hour period and 48 actuations in 24 hours.