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

NCT ID: NCT03731364

Last Updated: 2022-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-29
• Study Completion Date: 2019-05-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CA-008 5 mg (0.05 mg/mL) Cohort 1

Cohort 1 (5 mg), was prepared at 0.05 mg/mL CA-008 (vocacapsaicin)

Group Type: ACTIVE_COMPARATOR

CA-008

Intervention Type: DRUG

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)

Placebo - Cohort 1

Placebo for Cohort 1

Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

CA-008 10 mg (0.1 mg/mL) Cohort 2

Cohort 2 (10 mg), was prepared at 0.1 mg/mL CA-008 (vocacapsaicin)

Group Type: ACTIVE_COMPARATOR

CA-008

Intervention Type: DRUG

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)

CA-008 15 mg (0.15 mg/mL) Cohort 3

Cohort 3 (15 mg), was prepared at 0.15 mg/mL CA-008 (vocacapsaicin)

Group Type: ACTIVE_COMPARATOR

CA-008

Intervention Type: DRUG

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)

Placebo - Cohorts 2 and 3

Placebo - Cohorts 2 and 3

Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

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)

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

vocacapsaicin

Eligibility Criteria

Inclusion Criteria

1. Plan to undergo an elective primary unilateral total knee arthroplasty (TKA or knee replacement), without collateral procedure or additional surgeries.

2. Be a reasonably healthy adult aged 18 - 80 years old, inclusive, with a BMI ≤ 36 kg/m2 and American Society of Anesthesiology (ASA) physical Class 1, 2 or 3 at the time of randomization.

3. Males and females must abstain from intercourse, use acceptable birth control methods or be sterile or otherwise incapable of having children.

4. Be willing and able to sign the informed consent form (ICF)

5. Be willing and able to complete study procedures and pain scales and to communicate meaningfully in English. Be able and willing to return for outpatient follow up visits as required.

Exclusion Criteria

1. In the opinion of the Investigator,

1. have a concurrent painful condition, other than pain in the knee to be replaced, that may require pain treatment during the study period.

2. have active skin disease or other clinically significant abnormality at the anticipated site of surgery that could interfere with the planned surgery.

2. Have a known allergy to chili peppers, capsaicin or the components of CA-008, ropivacaine, ketorolac, acetaminophen, fentanyl, hydromorphone, morphine or oxycodone.

3. Have significant medical, neuropsychiatric or other condition.

4. The following are considered disallowed medications:

1. tolerant to opioids as defined

2. capsaicin-containing products or foods.

3. central nervous system active agent as an analgesic adjunct medication

4. antiarrhythmics except beta-blockers, digoxin, warfarin, lithium, or aminoglycosides or other antibiotics for an infection

5. parenteral or oral corticosteroids.

6. antianginal, antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days or which is not expected to remain stable while participating in the study.

5. Have positive results on the alcohol breath/saliva test indicative of alcohol abuse or urine drug screen indicative of illicit drug use at screening, and/or prior to surgery.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Concentric Analgesics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daneshvari Solanki, MD

Role: PRINCIPAL_INVESTIGATOR

First Surgical Hospital

Locations

HD Research

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CA-PS-203

Identifier Type: -

Identifier Source: org_study_id