Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (Vocacapsaicin)

A Two-Part, Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Adaptive Safety, Pharmacokinetics and Preliminary Efficacy Study of CA-008 in Patients Undergoing Total Knee Arthroplasy

In the pilot (Part A) of this study, multiple doses of CA-008 (vocacapsaicin) were evaluated for safety, tolerability, and PK. Doses were then selected for the expanded part (Part B) of the study, where CA-008 was compared to placebo. Patients had serial assessments of safety, PK, and drug effect.

Study Overview

• Status: Completed
• Conditions: Postsurgical Pain
• Intervention / Treatment: Drug: CA-008; Drug: Placebo

Detailed Description

Not provided

• Study Type: Interventional
• Enrollment (Actual): 193
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91105
      • Lotus Clinical Reserach, LLC
  • Texas
    • Carrollton, Texas, United States, 75006
      • Legent Orthopedic Hospital
    • Houston, Texas, United States, 77401
      • First Surgical Hospital
    • Plano, Texas, United States, 75093
      • Plano Surgical Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Scheduled elective Total Knee Arthroplasty (TKA) under spinal anesthesia
• Aged 18-80 years old
• ASA physical class 1, 2, or 3
• BMI </= 42 kg/m2
• Generally healthy

Exclusion Criteria:

• Concurrent condition requiring analgesic treatment during study period
• Opioid tolerant
• Known allergy to capsaicin or other study medication
• Use of prohibited medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CA-008 36 mg; Single administration (0.3 mg/mL concentration)	Drug: CA-008; Local administration during surgery; Other Names: vocacapsaicin
Active Comparator: CA-008 60 mg; Single administration (0.5 mg/mL concentration)	Drug: CA-008; Local administration during surgery; Other Names: vocacapsaicin
Active Comparator: CA-008 90 mg; Single administration (0.75 mg/mL concentration)	Drug: CA-008; Local administration during surgery; Other Names: vocacapsaicin
Placebo Comparator: Placebo; Single administration	Drug: Placebo; Local administration during surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Intensity Scores	Mean area under the curve (AUC) of the Numeric Rating Scale (NRS) weighted sum of pain intensity scores (at rest) from 0-10 where 0 is no pain and 10 is the worst pain imaginable for CA-008 compared to placebo. AUC is calculated using the standard trapezoidal rule from serial measures of NRS taken every 4 hours from 0-96 hours following surgery and twice daily from 96h to Day 15	0 to 192 hours post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Opioid Consumption	CA-008 versus placebo comparison, total opioid consumption in oral morphine equivalents	0 to Day 15 post dose

Collaborators and Investigators

• Sponsor: Concentric Analgesics
• Investigators: Principal Investigator: Daneshvari Solanki, MD, HD Research

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2019
• Primary Completion (Actual): October 26, 2020
• Study Completion (Actual): October 26, 2020

Study Registration Dates

• First Submitted: December 16, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: December 17, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: CA-PS-208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No