A Phase 3 Study to Evaluate the Safety and Efficacy of SKY0402 in Subjects Undergoing Total Knee Arthroplasty

Phase 3 Completed 245 enrolled Pacira Pharmaceuticals, Inc

RandomizedParallel-groupDouble-blindSupportive care

Summary

The primary objective is to demonstrate that SKY0402 is superior when compared to bupivacaine HCl in the management of postoperative pain for patients undergoing total knee arthroplasty.

Timeline

Start: 2008-08
Primary completion: 2009-01
Completion: 2009-02

Publications

Dasta J, Ramamoorthy S, Patou G, Sinatra R. Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. Curr Med Res Opin. 2012 Oct;28(10):1609-15. doi: 10.1185/03007995.2012.721760. Epub 2012 Sep 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bupivacaine	Other / unclassified	200 mg	Other
Subject	SKY0402	Unknown	600 mg	Other

Indications

No indication recorded.