Open-Label CA-008 (Vocacapsaicin) in Bunionectomy

An Open-Label Study of Intraoperative CA-008 Administration in Subjects Undergoing Bunionectomy

A Phase 2, open-label study of CA-008 to evaluate post-surgical pain control with CA-008.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: CA-008; Drug: Ketorolac; Drug: Acetaminophen IV; Drug: Fentanyl; Drug: Bupivacaine Hydrochloride; Drug: Lidocaine HCl; Drug: Celecoxib; Drug: Acetaminophen Oral; Drug: Lidocaine Hydrochloride; Drug: Exparel

Detailed Description

This is a Phase 2, single-center, open-label study evaluating a single dose of CA-008 4.2 mg administered with different standard-of-care anesthetic regimens during an elective unilateral transpositional first metatarsal osteotomy for the correction of hallux valgus deformity (bunionectomy).

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91105
      • Lotus Clinical Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adult aged 18 - 65 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 ≤ 36 kg/m2

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 study medications.
4. Have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values
5. Have positive results on the alcohol test (breath or saliva) or urine drug screen.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CA-008 Cohort 1; CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block followed by a sciatic (popliteal) nerve block.	Drug: CA-008; Drug: CA-008 4.2 mg reconstituted in saline; Other Names: Vocacapsaicin; Drug: Ketorolac; 30 mg IV at the onset of anesthesia; Drug: Acetaminophen IV; 1 g at the onset of anesthesia; Drug: Fentanyl; 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery; Drug: Bupivacaine Hydrochloride; 0.25% 30 mL (75 mg) prior to surgery; Drug: Lidocaine HCl; 1.5% 12 mL at the end of surgery; Drug: Celecoxib; 200 mg PO bid each day postoperative; Drug: Acetaminophen Oral; 1 g postoperative
Experimental: CA-008 Cohort 2; CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block.	Drug: CA-008; Drug: CA-008 4.2 mg reconstituted in saline; Other Names: Vocacapsaicin; Drug: Ketorolac; 30 mg IV at the onset of anesthesia; Drug: Acetaminophen IV; 1 g at the onset of anesthesia; Drug: Fentanyl; 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery; Drug: Bupivacaine Hydrochloride; 0.25% 30 mL (75 mg) prior to surgery; Drug: Celecoxib; 200 mg PO bid each day postoperative; Drug: Acetaminophen Oral; 1 g postoperative; Drug: Lidocaine Hydrochloride; 2% 15 mL at the end of surgery
Experimental: CA-008 Cohort 3; CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block.	Drug: CA-008; Drug: CA-008 4.2 mg reconstituted in saline; Other Names: Vocacapsaicin; Drug: Ketorolac; 30 mg IV at the onset of anesthesia; Drug: Acetaminophen IV; 1 g at the onset of anesthesia; Drug: Fentanyl; 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery; Drug: Bupivacaine Hydrochloride; 0.25% 30 mL (75 mg) prior to surgery; Drug: Lidocaine Hydrochloride; 2% 15 mL at the end of surgery
Active Comparator: Exparel; 106 mg [8 mL of the 133 mg/10 mL suspension] only All subjects received monitored anesthesia care (MAC) and a Mayo block.	Drug: Ketorolac; 30 mg IV at the onset of anesthesia; Drug: Acetaminophen IV; 1 g at the onset of anesthesia; Drug: Fentanyl; 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery; Drug: Bupivacaine Hydrochloride; 0.25% 30 mL (75 mg) prior to surgery; Drug: Lidocaine Hydrochloride; 2% 15 mL at the end of surgery; Drug: Exparel; Bupivacaine liposome injection suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve (AUC) of Numerical Rating Scale (NRS) Scores (at Rest) Over 72h	Area Under the Curve of pain intensity scores (using a Numeric Rating Scale of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable) over 72 hours	0-72 hours
Pain Intensity Scores at 24 Hours at Rest Using Numerical Rating Scale (NRS)	Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 24 hours	24 hours
Pain Intensity Scores at 48 Hours at Rest Using Numerical Rating Scale (NRS)	Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 48 hours	48 hours
Pain Intensity Scores at 72 Hours at Rest Using Numerical Rating Scale (NRS)	Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 72 hours	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption	Summary of opioid consumption in oral morphine equivalents	0-72 hours

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2019
• Primary Completion (Actual): July 2, 2019
• Study Completion (Actual): October 22, 2019

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): October 27, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Adjuvants, Anesthesia; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Cyclooxygenase 2 Inhibitors; Fentanyl; Lidocaine; Ketorolac; Celecoxib; Acetaminophen; Bupivacaine
• Other Study ID Numbers: CA-PS-205

Drug and device information, study documents

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