At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 193 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 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing First Metatarsal Osteotomy (Bunionectomy)
In Brief
A Phase 3 clinical trial evaluating SKY0402 and Placebo for Bunion and Hallux Valgus. Completed, enrolled 193 participants across 1 site.
Detailed Summary
After undergoing bunion surgery, patients are given a pain medicine injection that may last for up to several days or a placebo. Their pain and pain medicine use is then monitored.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBunion, Hallux Valgus
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2009
First PostedApr 2009
Primary CompletionNov 2009
TodayJul 2026
First PostedApr 30, 2009
Enrollment StartApr 1, 2009
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.2 years ago
Interventions
SKY0402drug
Local infiltration of 8cc SKY0402
Placebodrug
Local infiltration of 8cc Placebo