Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients

Post-surgical Pain Clinical Trial

Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Safety, Pharmacokinetics and Efficacy Study of CA-008 in Subjects Undergoing Bunionectomy

Status Completed

Clinical Trial 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).

Clinical Trial Description

Primary Objective:

To evaluate the efficacy of a single intraoperative administration of CA- 008 vs placebo in subjects undergoing an elective Bunionectomy .

Secondary Objectives

• To evaluate the safety and tolerability of a single intraoperative administration of CA-008 vs. placebo in subjects undergoing an elective Bunionectomy.

• To evaluate the PK profile of a single intraoperative administration of CA-008 vs. placebo in subjects undergoing an elective Bunionectomy .

• To explore the efficacy of various doses of CA-008 administered intraoperatively in subjects undergoing an elective Bunionectomy . ;

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-surgical Pain

• NCT number: NCT03599089
• Study type: Interventional
• Source: Concentric Analgesics
• Status: Completed
• Phase: Phase 2
• Start date: July 9, 2018
• Completion date: October 23, 2018