Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients

Phase 2

Completed

• Conditions: Post-surgical Pain
• Interventions: Drug: CA-008; Drug: Placebo; Drug: Ketorolac; Drug: Acetaminophen; Drug: Oxycodone; Drug: Bupivacaine Hydrochloride

• Registration Number: NCT03599089
• Lead Sponsor: Concentric Analgesics

Brief Summary

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).

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 Timeline

• Study First Submitted: 2018-06-27
• Study Start: 2018-07-09
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-26
• Primary Completion: 2018-10-10
• Study Completion: 2018-10-23
• Disposition First Submitted: 2020-05-27
• Results First Submitted: 2021-06-25
• Status Verified: 2021-07
• Results First Submitted QC: 2021-07-19
• Disposition First Submitted QC: 2021-07-19
• Last Update Submitted: 2021-07-19
• Results First Posted: 2021-08-11
• Disposition First Posted: 2021-08-11
• Last Update Posted: 2021-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration)	CA-008	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.
CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration)	CA-008	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.
CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration)	CA-008	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.
Placebo	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.
CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration)	Ketorolac	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.
CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration)	Acetaminophen	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.
CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration)	Oxycodone	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.
CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration)	Bupivacaine Hydrochloride	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.
CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration)	Acetaminophen	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.
CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration)	Ketorolac	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.
CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration)	Oxycodone	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.
CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration)	Bupivacaine Hydrochloride	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.
CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration)	Oxycodone	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.
CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration)	Bupivacaine Hydrochloride	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.
CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration)	Ketorolac	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.
Placebo	Oxycodone	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.
CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration)	Acetaminophen	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.
Placebo	Ketorolac	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.
Placebo	Acetaminophen	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.
Placebo	Bupivacaine Hydrochloride	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.

Primary Outcome Measures

Name	Time	Method
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)	[time frame: 96 hours]	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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Lotus Clinical Research, LLC; 🇺🇸 Pasadena, California, United States

Chesapeake Research Group; 🇺🇸 Pasadena, Maryland, United States

HD Research Corp; 🇺🇸 Houston, Texas, United States