NCT03731364

Study of CA-008 (Vocacapsaicin) in Total Knee Arthroplasty

A Phase 2, Randomized, Double-blind, Placebo-Controlled Efficacy, Pharmacokinetics and Safety Study of CA-008 (Vocacapsaicin) in Subjects Undergoing Total Knee Arthroplasty

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Concentric Analgesics · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a two-part, Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study of CA-008 (vocacapsaicin) vs. placebo injected/instilled during an elective TKA.

Detailed description

This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study evaluating, in a pilot stage of the study, up to 3 ascending dose level cohorts each evaluating a single dose of CA-008 vs. placebo injected/instilled during an elective TKA. Up to 54 subjects will be randomized in the pilot stage. During the optional second stage of the study, subjects will be randomized to one of either 2 or 3 CA-008 dose levels (to be determined) or placebo. The Sponsor made the decision not to proceed with the second stage.

Conditions

• Postsurgical Pain

Interventions

Type	Name	Description
DRUG	CA-008	5 mg CA-008 (0.05 mg/mL), 10 mg CA-008 (0.1 mg/mL) and 15 mg CA-008 (0.15 mg/mL)
DRUG	Placebo	Placebo

Timeline

• Start date: 2018-10-29
• Primary completion: 2019-04-30
• Completion: 2019-05-31
• First posted: 2018-11-06
• Last updated: 2022-02-15
• Results posted: 2022-02-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study