At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 204 enrolled
Drug / intervention
Bupivacaine HCl +1 moredrug
Likely dose
Bupivacaine HCl 100 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.
Phase 3, Multicenter, Randomized, Double-Blind, Parallel-group, Active-control Study to Evaluate the Safety and Efficacy of a Single Administration of SKY0402 for Prolonged Postoperative Analgesia in Subjects Undergoing Hemorrhoidectomy
In Brief
A Phase 3 clinical trial evaluating Bupivacaine HCl and SKY0402 for Hemorrhoids. Completed, enrolled 204 participants across 20 sites.
Detailed Summary
Effective postoperative pain control to promote improved healing, faster patient mobilization, shortened hospital stays, and reduced healthcare costs.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemorrhoids
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2008
First PostedSep 2008
Primary CompletionFeb 2009
TodayJul 2026
First PostedSep 1, 2008
Enrollment StartAug 1, 2008
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 17.8 years ago
Interventions
Bupivacaine HCldrug
100 mg Bupivacaine HCl
SKY0402drug
Single administration 300 mg SKY0402 in a 40-mL injection volume