NCT03599089

Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Concentric Analgesics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed 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 .

Conditions

• Post-surgical Pain

Interventions

Type	Name	Description
DRUG	CA-008	single-dose wound infiltration prior to surgical incision closure
DRUG	Placebo	single-dose wound infiltration prior to surgical incision closure
DRUG	Ketorolac	30mg IV administered intraoperatively
DRUG	Acetaminophen	1000mg IV administered intraoperatively
DRUG	Oxycodone	5mg PO prn post-surgery
DRUG	Bupivacaine Hydrochloride	0.5% infiltration pre-surgery

Timeline

• Start date: 2018-07-09
• Primary completion: 2018-10-10
• Completion: 2018-10-23
• First posted: 2018-07-26
• Last updated: 2021-08-11
• Results posted: 2021-08-11

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study