At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 98 enrolled
Drug / intervention
Bupivacaine HCl +1 moredrug
Likely dose
Not stated in 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 and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Primary Unilateral Inguinal Hernia Repair.
In Brief
A Phase 2 clinical trial evaluating Bupivacaine HCl and SKY0402 for Postoperative Pain. Completed, enrolled 98 participants across 7 sites.
Detailed Summary
The purpose of this study is to evaluate three dose levels of SKY0402 compared with 105 mg of bupivacaine HCl.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2007
First PostedJun 2007
Primary CompletionDec 2007
Study CompletionAug 2008
TodayJul 2026
First PostedJun 13, 2007
Enrollment StartJun 1, 2007
Primary CompletionDec 1, 2007
Study CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 19.1 years ago
Interventions
Bupivacaine HCldrug
Bupivacaine HCl given during hernia repair
SKY0402drug
SKY0402 given during hernia repair