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

NCT03731364 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CA-PS-203
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Postsurgical Pain

Outcome Measures

Primary Outcomes (2)

• Time-specific Mean Pain Intensity Scores (NRS) at Time 96 Hours for CA-008 vs. Placebo

  Primary Efficacy Endpoint for the Pilot Stage. Time-specific mean pain intensity scores at Time 96 hours for CA-008 vs. placebo based on a 10-point numerical rating scale (NRS) from 0-10 where 0 is no pain and 10 is the worst pain imaginable).

  At 96 hours

• CA-008 Dose vs. Placebo Comparison: Area Under the Curve (AUC) 0 to 96 Hours

  Primary Efficacy Endpoint for Stage 2. Area Under the Curve (AUC) of the NRS current pain intensity scores from Time 0 hours to 96 hours at rest (AUC0 to 96h) where 0 is no pain and 10 is the worst pain imaginable for CA-008 compared to placebo. • During the inpatient stay, NRS at rest beginning with the PACU admission may be assessed once the subject is awake. The maximum is an NRS score of 10 x all 96 hours = 960 NRS units\*hrs; the minimum is 0 x 96h = 0 NRS units\*hrs

  From 0 hours to 96 hours

Secondary Outcomes (2)

• Percentage of Subjects Who do Not Require Opioids

  Time 0 hours to Time 96 hours: Opioid Free 0 hours to 96 hours

• Total Opioid Consumption (in Daily Oral Morphine Equivalents)

  OC from Time 0 hours to Time 96 hours: OC 0 hours to 96 hours

Study Arms (5)

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

ACTIVE COMPARATOR

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

Drug: CA-008

Placebo - Cohort 1

PLACEBO COMPARATOR

Placebo for Cohort 1 Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active

Drug: Placebo

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

ACTIVE COMPARATOR

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

Drug: CA-008

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

ACTIVE COMPARATOR

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

Drug: CA-008

Placebo - Cohorts 2 and 3

PLACEBO COMPARATOR

Placebo - Cohorts 2 and 3 Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active

Drug: Placebo

Interventions

CA-008 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)

Also known as: vocacapsaicin

CA-008 10 mg (0.1 mg/mL) Cohort 2; CA-008 15 mg (0.15 mg/mL) Cohort 3; CA-008 5 mg (0.05 mg/mL) Cohort 1

Placebo DRUG

Placebo

Placebo - Cohort 1; Placebo - Cohorts 2 and 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Plan to undergo an elective primary unilateral total knee arthroplasty (TKA or knee replacement), without collateral procedure or additional surgeries.
• 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.
• Males and females must abstain from intercourse, use acceptable birth control methods or be sterile or otherwise incapable of having children.
• Be willing and able to sign the informed consent form (ICF)
• 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.

You may not qualify if:

• In the opinion of the Investigator,
• have a concurrent painful condition, other than pain in the knee to be replaced, that may require pain treatment during the study period.
• have active skin disease or other clinically significant abnormality at the anticipated site of surgery that could interfere with the planned surgery.
• Have a known allergy to chili peppers, capsaicin or the components of CA-008, ropivacaine, ketorolac, acetaminophen, fentanyl, hydromorphone, morphine or oxycodone.
• Have significant medical, neuropsychiatric or other condition.
• The following are considered disallowed medications:
• tolerant to opioids as defined
• capsaicin-containing products or foods.
• central nervous system active agent as an analgesic adjunct medication
• antiarrhythmics except beta-blockers, digoxin, warfarin, lithium, or aminoglycosides or other antibiotics for an infection
• parenteral or oral corticosteroids.
• 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.
• 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.

Sponsors & Collaborators

• Concentric Analgesics: lead

Study Sites (1)

HD Research

Houston, Texas, 77402, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Nancy Wu
• Organization: Concentric Analgesics

nancy@concentricanalgesics.com

(415) 484-7921

Study Officials

• Daneshvari Solanki, MD

  First Surgical Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: November 6, 2018
• Study Start: October 29, 2018
• Primary Completion: April 30, 2019
• Study Completion: May 31, 2019
• Last Updated: February 15, 2022
• Results First Posted: February 15, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)