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

Primary Purpose

Postsurgical Pain

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

CA-008

Placebo

About this trial

This is an interventional treatment trial for Postsurgical Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

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.

Key Exclusion Criteria:

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.
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:
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.
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.

Sites / Locations

HD Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

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

Placebo - Cohort 1

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

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

Placebo - Cohorts 2 and 3

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

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).

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

Secondary Outcome Measures

Percentage of Subjects Who do Not Require Opioids

Key Secondary Efficacy Endpoints for Stage 2. For each CA-008 dose vs. placebo comparison, percentage of subjects who do not require opioids.

Total Opioid Consumption (in Daily Oral Morphine Equivalents)

Key Secondary Efficacy Endpoints for Stage 2. Mean total postoperative opioid consumption (in daily oral morphine equivalents) for CA-008 compared to placebo

Full Information

NCT ID

NCT03731364

First Posted

October 24, 2018

Last Updated

January 25, 2022

Sponsor

Concentric Analgesics

1. Study Identification

Unique Protocol Identification Number

NCT03731364

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

October 29, 2018 (Actual)

Primary Completion Date

April 30, 2019 (Actual)

Study Completion Date

May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Concentric Analgesics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postsurgical Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo - Cohort 1

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Arm Title

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

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo - Cohorts 2 and 3

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

CA-008

Other Intervention Name(s)

vocacapsaicin

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

Placebo

Primary Outcome Measure Information:

Title

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

Description

Time Frame

At 96 hours

Title

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

Description

Time Frame

From 0 hours to 96 hours

Secondary Outcome Measure Information:

Title

Percentage of Subjects Who do Not Require Opioids

Description

Key Secondary Efficacy Endpoints for Stage 2. For each CA-008 dose vs. placebo comparison, percentage of subjects who do not require opioids.

Time Frame

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

Title

Total Opioid Consumption (in Daily Oral Morphine Equivalents)

Description

Key Secondary Efficacy Endpoints for Stage 2. Mean total postoperative opioid consumption (in daily oral morphine equivalents) for CA-008 compared to placebo

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: 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. Key Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daneshvari Solanki, MD

Organizational Affiliation

First Surgical Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

HD Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77402

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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