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

PHASE3CompletedINTERVENTIONAL
Enrollment

125

Participants

Timeline

Start Date

May 31, 2002

Primary Completion Date

March 31, 2004

Study Completion Date

March 31, 2004

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)

L9 7LJ

Clinical Trials Unit, The Walton Centre, Fazakerley

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY