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Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients

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ClinicalTrials.gov Identifier: NCT03599089
Recruitment Status : Completed
First Posted : July 26, 2018
Results First Posted : August 11, 2021
Last Update Posted : August 11, 2021
Sponsor:
Information provided by (Responsible Party):
Concentric Analgesics

Study Description
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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).

Condition or disease Intervention/treatment Phase
Post-surgical Pain Drug: CA-008 Drug: Placebo Drug: Ketorolac Drug: Acetaminophen Drug: Oxycodone Drug: Bupivacaine Hydrochloride Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Safety, Pharmacokinetics and Efficacy Study of CA-008 in Subjects Undergoing Bunionectomy
Actual Study Start Date : July 9, 2018
Actual Primary Completion Date : October 10, 2018
Actual Study Completion Date : October 23, 2018
Arms and Interventions
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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 Name: 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 Name: 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 Name: 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: Placebo
single-dose wound infiltration prior to surgical incision closure

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


Outcome Measures
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Primary Outcome Measures :
  1. 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: [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 :
  1. Percentage of Subjects Opioid Free [ Time Frame: [time frame: 96 hours] ]
    Percentage of subjects who are opioid-free for CA-008 compared to placebo.

  2. Total Opioid Consumption (in Daily Morphine Equivalents) [ Time Frame: [time frame: 96 hours] ]
    Mean total postoperative opioid consumption (in daily oral morphine equivalents) for CA-008 compared to placebo


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599089


Locations
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United States, California
Lotus Clinical Research, LLC
Pasadena, California, United States, 91105
United States, Maryland
Chesapeake Research Group
Pasadena, Maryland, United States, 21122
United States, Texas
HD Research Corp
Houston, Texas, United States, 77004
Sponsors and Collaborators
Concentric Analgesics
Investigators
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Study Director: Nancy Wu Concentric Analgesics
  Study Documents (Full-Text)

Documents provided by Concentric Analgesics:
Study Protocol  [PDF] June 6, 2018
Statistical Analysis Plan  [PDF] October 9, 2018

More Information
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Responsible Party: Concentric Analgesics
ClinicalTrials.gov Identifier: NCT03599089    
Other Study ID Numbers: CA-PS-201
First Posted: July 26, 2018    Key Record Dates
Results First Posted: August 11, 2021
Last Update Posted: August 11, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Acetaminophen
Ketorolac
Oxycodone
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Antipyretics
Analgesics, Opioid
Narcotics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action