NCT00485693

Dose-Ranging Study for Prolonged Postoperative Analgesia in Subject Undergoing Total Knee Arthroplasty

A Phase 2 Multicenter, Randomized, Double-blind, Parallel-group, Active-control, Dose-ranging Study to Evaluate the Safety, Efficacy, and Comparative Systemic Bioavailability of a Single Administration of SKY0402 Via Local Infiltration for Prolonged Postoperative Analgesia in Subjects Undergoing Total Knee Arthroplasty.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Dose-ranging study for prolonged postoperative analgesia in subjects undergoing total knee arthroplasty

Detailed description

This is a phase 2, multicenter, parallel-group, active-control, randomized, double-blind, dose-ranging study conducted to evaluate three dose levels of SKY0402 compared with 150 mg of bupivacaine HCl.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Bupivacaine HCl	150 mg Bupivacaine HCl
DRUG	SKY0402	600 mg SKY0402 (study drug)

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2007-06-13
• Last updated: 2022-06-28
• Results posted: 2013-08-06

Locations

9 sites across 2 countries: United States, Czechia