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 Efficacy, Pharmacokinetics and Safety Study of CA-008 in Subjects Undergoing Complete Abdominoplasty
In Brief
A Phase 2 clinical trial evaluating CA-008 5 mg, Placebo, and 7 other interventions for Postsurgical Pain. Completed, enrolled 54 participants across 1 site.
Detailed Summary
Phase 2, single center, randomized, double-blind, placebo-controlled, parallel design study of CA-008 vs. placebo in subjects undergoing an elective C-ABD under general anesthesia supplemented with a bupivacaine hydrochloride (HCl)transverse abdominis plane (TAP) block.
Study Details
Timeline
Interventions
5 mg CA-008 reconstituted in saline.
Each cohort will use placebo reconstituted in saline.
0.25% administered pre-surgery
0.02 mg/kg IV administered intraoperatively
100 mcg IV administered intraoperatively
1000 mg IV administered intraoperatively
5-10 mg PO administered post-surgery
10 mg CA-008 reconstituted in saline.
15 mg CA-008 reconstituted in saline.