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

NCT00678795 Phase 3 COMPLETED Results posted

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

Details

Lead sponsor	Jazz Pharmaceuticals
Phase	Phase 3
Status	COMPLETED
Enrolment	135
Start date	2002-08
Completion	2005-10

Conditions

• Detrusor Overactivity
• Multiple Sclerosis

Interventions

• Sativex®
• Placebo

Primary outcomes

• Change From Baseline in the Mean Daily Number of Incontinence Episodes at the End of Treatment — 0 - 10 weeks
  To assess the effect of Sativex in neurogenic overactive bladder, the incontinence episode frequency was selected as the primary endpoint. Baseline was the average of all available data recorded during the 14 days immediately prior to the randomisation visit. End of Treatment was the last average available from Week 3, Week 5, and Weeks 7-8. A negative value indicates an improvement in score from baseline.

Countries

United Kingdom