NCT00710424View on ClinicalTrials.gov

A Study of Sativex® for Pain Relief Due to Diabetic Neuropathy

PHASE3CompletedINTERVENTIONAL

Enrollment

297

Participants

Timeline

Start Date

July 31, 2005

Primary Completion Date

June 30, 2006

Study Completion Date

June 30, 2006

Conditions

PainDiabetic 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)

S10 2JF

Royal Hallamshire Hospital, Sheffield