A Study of Sativex® for Pain Relief of Peripheral Neuropathic Pain, Associated With Allodynia

PHASE3CompletedINTERVENTIONAL
Enrollment

246

Participants

Timeline

Start Date

August 31, 2005

Primary Completion Date

October 31, 2006

Study Completion Date

October 31, 2006

Conditions
PainPeripheral Neuropathy
Interventions
DRUG

Sativex

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

DRUG

Placebo

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.

Trial Locations (1)

G12 0YN

Pain Clinic Office, Gartnavel General Hospital,, Glasgow

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY