Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients

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 . ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

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

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