At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 138 enrolled
Drug / intervention
Bupivacaine HCl +1 moredrug
Likely dose
Bupivacaine HCl 150 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 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.
In Brief
A Phase 2 clinical trial evaluating Bupivacaine HCl and SKY0402 for Postoperative Pain. Completed, enrolled 138 participants across 9 sites in 2 countries.
Detailed Summary
Dose-ranging study for prolonged postoperative analgesia in subjects undergoing total knee arthroplasty
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain
CountriesCzechia, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2007
First PostedJun 2007
Primary CompletionAug 2009
TodayJul 2026
First PostedJun 13, 2007
Enrollment StartJun 1, 2007
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 19.1 years ago
Interventions
Bupivacaine HCldrug
150 mg Bupivacaine HCl
SKY0402drug
600 mg SKY0402 (study drug)