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

PHASE3CompletedINTERVENTIONAL
Enrollment

245

Participants

Timeline

Start Date

August 31, 2008

Primary Completion Date

January 31, 2009

Study Completion Date

February 28, 2009

Conditions
Postoperative Pain
Interventions
DRUG

Bupivacaine HCl

200 mg bupivacaine HCl

DRUG

SKY0402

600 mg SKY0402 (study drug).

Trial Locations (19)

10065

Insall Scott Kelly Institute, New York

15904

Ilumina Clinical Associates, Johnstown

16602

Allegheny Pain Management, Altoona

27710

Duke University Medical Center, Raleigh-Durham

27834

CTMG, Inc., Greenville

30033

Atlanta Knee and Sports Medicine, Decatur

35209

West Alabama Research, Inc., Birmingham

36106

Drug Research and Analysis Corporation, Montgomery

36608

Horizon Research Group, Inc., Alabama Orthopaedic Clinic, Mobile

38301

Research Associates of Jackson, Jackson

43210

Ohio State University Medical Center, Columbus

60612

Rush University Medical Center, Chicago

76051

Texas Orthopedic Specialists, PA, Grapevine

77024

Memorial Hermann City Hospital, Houston

85375

Sun Health Research Institute, Core Institute, Sun City West

90048

Cedars of Sinai Medical Center, Los Angeles

92037

Scripps, La Jolla

92653

Accurate Clinical Trials, Inc., Laguna Hills

Physicans Clinical Research Corp., Laguna Hills

Sponsors
All Listed Sponsors
lead

Pacira Pharmaceuticals, Inc

INDUSTRY