Evaluation of the Safety and Efficacy of a Single Dose of SKY0402 in Subjects Undergoing Augmentation Mammoplasty

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

March 31, 2008

Primary Completion Date

August 31, 2008

Study Completion Date

December 31, 2008

Conditions
Postoperative Pain
Interventions
DRUG

SKY0402 + bupivacaine HCl

Low-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket

DRUG

Mid-dose SKY0402 + bupivacaine HCl

Mid-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket

Trial Locations (1)

92037

Associates for Plastic Surgery, La Jolla

Sponsors
All Listed Sponsors
lead

Pacira Pharmaceuticals, Inc

INDUSTRY