Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients

A Phase 2, Randomized, Double-blind, Placebo-controlled Safety, Pharmacokinetics and Efficacy Study of CA-008 in Subjects Undergoing Bunionectomy

This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study evaluating a single dose of one of three CA-008 dose levels vs. placebo injected during an elective bunionectomy Bunionectomy to assess post-surgical pain management and the need for rescue medication (oxycodone).

Study Overview

• Status: Completed
• Conditions: Post-surgical Pain
• Intervention / Treatment: Drug: CA-008; Drug: Ketorolac; Drug: Acetaminophen; Drug: Oxycodone; Drug: Bupivacaine Hydrochloride; Drug: Placebo

Detailed Description

Primary Objective:

To evaluate the efficacy of a single intraoperative administration of CA- 008 vs placebo in subjects undergoing an elective Bunionectomy .

Secondary Objectives

• To evaluate the safety and tolerability of a single intraoperative administration of CA-008 vs. placebo in subjects undergoing an elective Bunionectomy.
• To evaluate the PK profile of a single intraoperative administration of CA-008 vs. placebo in subjects undergoing an elective Bunionectomy .
• To explore the efficacy of various doses of CA-008 administered intraoperatively in subjects undergoing an elective Bunionectomy .

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91105
      • Lotus Clinical Research, LLC
  • Maryland
    • Pasadena, Maryland, United States, 21122
      • Chesapeake Research Group
  • Texas
    • Houston, Texas, United States, 77004
      • HD Research Corp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adult aged 18 - 75 years old
2. American Society of Anesthesiology (ASA) physical Class 1, 2 or 3
3. Planning elective Bunionectomy repair
4. For both males and females: using an acceptable method of birth control
5. If a female: not pregnant or breastfeeding
6. Have a body mass index ≤ 40 kg/m2.
7. Be willing and able to sign the informed consent form (ICF)
8. Be able to complete study procedures and pain scales and to communicate meaningfully in English
9. Be willing to undergo 17 blood draws for pharmacokinetic (PK )assessments over 24 hours

Exclusion Criteria:

1. Have another painful condition, other than bunion-related pain, that may require pain treatment during the study period
2. Have active skin disease or another abnormality at the anticipated site of surgery that could interfere with the planned surgery.
3. Have a known allergy to chili peppers, capsaicin or the components of CA-008, bupivacaine HCl, ketorolac, acetaminophen or oxycodone.
4. Have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values
5. Be on any medication not allowed per the protocol
6. Within the past year have a history of illicit drug use or prescription medicine or alcohol abuse
7. Have positive results on the alcohol test (breath or saliva) or urine drug screen
8. Have previously participated in a clinical study with CA-008.
9. Have participated in another clinical trial or used an investigational product within 30 days or five half-lives (whichever is longer)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration); Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.	Drug: CA-008; single-dose wound infiltration prior to surgical incision closure; Other Names: Vocacapsaicin; Drug: Ketorolac; 30mg IV administered intraoperatively; Drug: Acetaminophen; 1000mg IV administered intraoperatively; Drug: Oxycodone; 5mg PO prn post-surgery; Drug: Bupivacaine Hydrochloride; 0.5% infiltration pre-surgery
Active Comparator: CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration); Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.	Drug: CA-008; single-dose wound infiltration prior to surgical incision closure; Other Names: Vocacapsaicin; Drug: Ketorolac; 30mg IV administered intraoperatively; Drug: Acetaminophen; 1000mg IV administered intraoperatively; Drug: Oxycodone; 5mg PO prn post-surgery; Drug: Bupivacaine Hydrochloride; 0.5% infiltration pre-surgery
Active Comparator: CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration); Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.	Drug: CA-008; single-dose wound infiltration prior to surgical incision closure; Other Names: Vocacapsaicin; Drug: Ketorolac; 30mg IV administered intraoperatively; Drug: Acetaminophen; 1000mg IV administered intraoperatively; Drug: Oxycodone; 5mg PO prn post-surgery; Drug: Bupivacaine Hydrochloride; 0.5% infiltration pre-surgery
Placebo Comparator: Placebo; Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.	Drug: Ketorolac; 30mg IV administered intraoperatively; Drug: Acetaminophen; 1000mg IV administered intraoperatively; Drug: Oxycodone; 5mg PO prn post-surgery; Drug: Bupivacaine Hydrochloride; 0.5% infiltration pre-surgery; Drug: Placebo; single-dose wound infiltration prior to surgical incision closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Postsurgical Pain Based on the Weighted Sum of Pain Intensity (SPI) Assessments Over 96 Hours of the NRS Scores = Area Under the Curve (AUC)	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. The time was collected 0 to 96 hours post-dose	[time frame: 96 hours]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Opioid Free	Percentage of subjects who are opioid-free for CA-008 compared to placebo.	[time frame: 96 hours]
Total Opioid Consumption (in Daily Morphine Equivalents)	Mean total postoperative opioid consumption (in daily oral morphine equivalents) for CA-008 compared to placebo	[time frame: 96 hours]

Collaborators and Investigators

• Sponsor: Concentric Analgesics
• Investigators: Study Director: Nancy Wu, Concentric Analgesics

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2018
• Primary Completion (Actual): October 10, 2018
• Study Completion (Actual): October 23, 2018

Study Registration Dates

• First Submitted: June 27, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Ketorolac; Acetaminophen; Bupivacaine; Oxycodone
• Other Study ID Numbers: CA-PS-201

Drug and device information, study documents

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