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

NCT03731364 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2022-02-15

Study results available
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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.

Conditions

  • Postsurgical Pain

Interventions

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

Sponsors & Collaborators

  • Concentric Analgesics

    lead INDUSTRY

Principal Investigators

  • Daneshvari Solanki, MD · First Surgical Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-29
Primary Completion
2019-04-30
Completion
2019-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03731364 on ClinicalTrials.gov