At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Double-blind, Placebo-controlled Safety, Pharmacokinetics and Efficacy Study of CA-008 in Subjects Undergoing Bunionectomy
In Brief
A Phase 2 clinical trial evaluating CA-008, Placebo, and 4 other interventions for Post-surgical Pain. Completed, enrolled 147 participants across 3 sites.
Detailed Summary
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study evaluating a single dose of one of three CA-008 dose levels vs. placebo injected during an elective bunionectomy Bunionectomy to assess post-surgical pain management and the need for rescue medication (oxycodone).
Study Details
Timeline
Interventions
single-dose wound infiltration prior to surgical incision closure
single-dose wound infiltration prior to surgical incision closure
30mg IV administered intraoperatively
1000mg IV administered intraoperatively
5mg PO prn post-surgery
0.5% infiltration pre-surgery