CLINICAL TRIALS PROFILE FOR CA-008

Clinical Trials for CA-008

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT03307837 ↗	A Phase 1 Study of Intraoperative Administration of CA-008 for the Correction of Hallux Valgus Deformity	Completed	Concentric Analgesics	Phase 1	This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose, sequential-group Phase 1 study. The study will be conducted utilizing a cohort design, with sequential groups of 8 subjects. Within each dose cohort, 6 subjects will be randomized to active, and 2 will be randomized to placebo.
NCT03599089 ↗	Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients	Completed	Concentric Analgesics	Phase 2	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).
NCT03731364 ↗	Pain Study in Total Knee Arthroplasty	Completed	Concentric Analgesics	Phase 2	This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study of CA-008 vs. placebo injected/instilled during an elective TKA.
NCT03789318 ↗	Study in Subjects Undergoing Complete Abdominoplasty	Completed	Concentric Analgesics	Phase 2	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.
NCT03885596 ↗	Open-Label CA-008 (Vocacapsaicin) in Bunionectomy	Completed	Concentric Analgesics	Phase 2	A Phase 2, open-label study of CA-008 to evaluate post-surgical pain control with CA-008.
NCT04203537 ↗	Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008	Completed	Concentric Analgesics	Phase 1/Phase 2	In the pilot Part A of this study, multiple doses of CA-008 will be evaluated for safety, tolerability and PK. Doses will then be selected for the expanded, main part of the study where CA-008 will be compared to placebo. Patients will have serial assessments of safety, PK, and drug effect.

Clinical Trial Conditions for CA-008

Condition Name

Condition Name for
Intervention	Trials
Post-surgical Pain	2
Postsurgical Pain	2
Acute Post-surgical Pain	1
Hallux Valgus Deformity	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Pain, Postoperative	5
Hernia, Ventral	1
Hallux Valgus	1
Congenital Abnormalities	1

Clinical Trial Locations for CA-008

Trials by Country

Trials by Country for
Location	Trials
United States	10

Trials by US State

Trials by US State for
Location	Trials
California	5
Texas	4
Maryland	1

Clinical Trial Progress for CA-008

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 2	4
Phase 1/Phase 2	2
Phase 1	1

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	6
Active, not recruiting	1

Clinical Trial Sponsors for CA-008

Sponsor Name

Sponsor Name for
Sponsor	Trials
Concentric Analgesics	7

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	7