At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 100 enrolled
Drug / intervention
SKY0402 +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 Subject Undergoing Hemorrhoidectomy
In Brief
A Phase 2 clinical trial evaluating SKY0402 and Bupivacaine HCl for Postoperative Pain. Completed, enrolled 100 participants across 7 sites in 2 countries.
Detailed Summary
Phase 2 study to evaluate three dose levels of SKY0402 compared with 75 mg of bupivacaine HCl.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostoperative Pain
CountriesGeorgia, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2007
First PostedSep 2007
Primary CompletionDec 2007
Study CompletionJul 2008
TodayJul 2026
First PostedSep 14, 2007
Enrollment StartSep 1, 2007
Primary CompletionDec 1, 2007
Study CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 18.8 years ago
Interventions
SKY0402drug
SKY0402
Bupivacaine HCldrug
Bupivacaine HCl