At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 58 enrolled
Drug / intervention
SKY0402 +1 moredrug
Likely dose
Bupivacaine HCl 125 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, Dose Escalating/ De-Escalating Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Sustained Release Encapsulated Bupivacaine (SKY0402) Administered as a Nerve Block in the Management of Postoperative Pain in Subjects Undergoing Bunionectomy
In Brief
A Phase 2 clinical trial evaluating SKY0402 and Bupivacaine HCl for Postoperative Pain. Completed, enrolled 58 participants.
Detailed Summary
The primary objective of this study was to determine the appropriate dose of SKY0402 administered as a nerve block for the management of postoperative pain following bunionectomy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2005
Primary CompletionMar 2006
Study CompletionDec 2006
First PostedSep 2010
TodayJul 2026
First PostedSep 22, 2010
Enrollment StartMar 1, 2005
Primary CompletionMar 1, 2006
Study CompletionDec 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 15.8 years ago
Interventions
SKY0402drug
Single dose of SKY0402 administered as a nerve block
Bupivacaine HCldrug
Single dose of 125 mg administered as a nerve block