NCT01606189 - A Study to Compare Sublingual Cannabis Based Medicine Extracts With Placebo to Treat Brachial Plexus Injury Pain | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 31, 2001

Primary Completion Date

September 30, 2002

Study Completion Date

September 30, 2002

Conditions

Pain

Interventions

DRUG

GW-1000-02

Contains delta-9-tetrahydrocannabinol (THC) (25 mg/ml) and cannabidiol (CBD) (25mg/ml) as extract of Cannabis sativa L, with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.5 mg and CBD 2.5 mg). The maximum daily exposure was set at 48 actuations per day.

DRUG

GW-2000-02

Contains THC (25 mg/ml) as extract of Cannabis sativa L, with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.5 mg). The maximum daily exposure was set at 48 actuations per day.

DRUG

Placebo

Contains 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. Each actuation delivered 100 μl. The maximum daily exposure was set at 48 actuations per day.

Trial Locations (1)

HA7 4LP

The Royal National Orthopaedic Hospital, Middlesex