Sativex Thorough QT/QTc Study

Phase 1 Completed 258 enrolled Jazz Pharmaceuticals

RandomizedParallel-groupQuadruple-blindBasic science

Summary

This study was to evaluate effects of Sativex on electrocardiogram (ECG) traces when administered at its therapeutic dose of 8 sprays per day and at multiples of the therapeutic dose (24 or 36 sprays per day), and to evaluate its safety and tolerability.

Timeline

Start: 2007-12
Primary completion: 2008-06
Completion: 2008-06

Publications

Results Sellers EM, Schoedel K, Bartlett C, Romach M, Russo EB, Stott CG, Wright S, White L, Duncombe P, Chen CF. A Multiple-Dose, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group QT/QTc Study to Evaluate the Electrophysiologic Effects of THC/CBD Spray. Clin Pharmacol Drug Dev. 2013 Jul;2(3):285-94. doi: 10.1002/cpdd.36. Epub 2013 May 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Moxifloxacin	Small molecule	400 mg	Oral
Comparator	Nabiximols	Other / unclassified	8 unknown	Other
Comparator	Nabiximols	Other / unclassified	24 unknown	Other
Comparator	Nabiximols	Other / unclassified	36 unknown	Other

Indications

No indication recorded.