19
Participants
Start Date
March 31, 2007
Primary Completion Date
July 31, 2007
Study Completion Date
July 31, 2007
Sativex®
Containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours
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
Pain Management Research, Clinical Trials Unit, Netherwood House, Solihull Hospital, Solihull
Lead Sponsor
Jazz Pharmaceuticals
INDUSTRY