At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 245 enrolled
Drug / intervention
Bupivacaine HCl +1 moredrug
Likely dose
Bupivacaine HCl 200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Active Control Study to Evaluate the Safety and Efficacy of a Single Intraoperative Administration of SKY0402 For Prolonged Postoperative Analgesia in Subject Undergoing Total Knee Arthroplasty
In Brief
A Phase 3 clinical trial evaluating Bupivacaine HCl and SKY0402 for Postoperative Pain. Completed, enrolled 245 participants across 19 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2008
First PostedSep 2008
Primary CompletionJan 2009
Study CompletionFeb 2009
TodayJul 2026
First PostedSep 3, 2008
Enrollment StartAug 1, 2008
Primary CompletionJan 1, 2009
Study CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 17.8 years ago
Interventions
Bupivacaine HCldrug
200 mg bupivacaine HCl
SKY0402drug
600 mg SKY0402 (study drug).