drugset / Trial / NCT03599089

Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients

NCT03599089

Phase 2 Completed 147 enrolled Concentric Analgesics
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2018-07-09
Primary completion
2018-10-10
Completion
2018-10-23

Drugs

EvaluationDrugModalityDoseRoute
Comparator vocacapsaicin Small molecule 0.7 mg Other
Comparator vocacapsaicin Small molecule 2.1 mg Other
Comparator vocacapsaicin Small molecule 4.2 mg Other
Comparator Acetaminophen Small molecule 1000 mg Intravenous
Comparator Bupivacaine Other / unclassified 0.5 % Other
Comparator Ketorolac Other / unclassified 30 mg Intravenous
Comparator Oxycodone Other / unclassified 5 mg Oral