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Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients

Primary Purpose

Post-surgical Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CA-008
Placebo
Ketorolac
Acetaminophen
Oxycodone
Bupivacaine Hydrochloride
Sponsored by
Concentric Analgesics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-surgical Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Lotus Clinical Research, LLC
  • Chesapeake Research Group
  • HD Research Corp

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration)

CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration)

CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration)

Placebo

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of Subjects Opioid Free
Percentage of subjects who are opioid-free for CA-008 compared to placebo.
Total Opioid Consumption (in Daily Morphine Equivalents)
Mean total postoperative opioid consumption (in daily oral morphine equivalents) for CA-008 compared to placebo

Full Information

First Posted
June 27, 2018
Last Updated
July 19, 2021
Sponsor
Concentric Analgesics
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1. Study Identification

Unique Protocol Identification Number
NCT03599089
Brief Title
Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients
Official Title
A Phase 2, Randomized, Double-blind, Placebo-controlled Safety, Pharmacokinetics and Efficacy Study of CA-008 in Subjects Undergoing Bunionectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 9, 2018 (Actual)
Primary Completion Date
October 10, 2018 (Actual)
Study Completion Date
October 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Concentric Analgesics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-surgical Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CA-008
Other Intervention Name(s)
Vocacapsaicin
Intervention Description
single-dose wound infiltration prior to surgical incision closure
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
single-dose wound infiltration prior to surgical incision closure
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
30mg IV administered intraoperatively
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
1000mg IV administered intraoperatively
Intervention Type
Drug
Intervention Name(s)
Oxycodone
Intervention Description
5mg PO prn post-surgery
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Intervention Description
0.5% infiltration pre-surgery
Primary Outcome Measure Information:
Title
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)
Description
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
[time frame: 96 hours]
Secondary Outcome Measure Information:
Title
Percentage of Subjects Opioid Free
Description
Percentage of subjects who are opioid-free for CA-008 compared to placebo.
Time Frame
[time frame: 96 hours]
Title
Total Opioid Consumption (in Daily Morphine Equivalents)
Description
Mean total postoperative opioid consumption (in daily oral morphine equivalents) for CA-008 compared to placebo
Time Frame
[time frame: 96 hours]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy adult aged 18 - 75 years old American Society of Anesthesiology (ASA) physical Class 1, 2 or 3 Planning elective Bunionectomy repair For both males and females: using an acceptable method of birth control If a female: not pregnant or breastfeeding Have a body mass index ≤ 40 kg/m2. Be willing and able to sign the informed consent form (ICF) Be able to complete study procedures and pain scales and to communicate meaningfully in English Be willing to undergo 17 blood draws for pharmacokinetic (PK )assessments over 24 hours Exclusion Criteria: Have another painful condition, other than bunion-related pain, that may require pain treatment during the study period Have active skin disease or another abnormality at the anticipated site of surgery that could interfere with the planned surgery. Have a known allergy to chili peppers, capsaicin or the components of CA-008, bupivacaine HCl, ketorolac, acetaminophen or oxycodone. Have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values Be on any medication not allowed per the protocol Within the past year have a history of illicit drug use or prescription medicine or alcohol abuse Have positive results on the alcohol test (breath or saliva) or urine drug screen Have previously participated in a clinical study with CA-008. Have participated in another clinical trial or used an investigational product within 30 days or five half-lives (whichever is longer)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Wu
Organizational Affiliation
Concentric Analgesics
Official's Role
Study Director
Facility Information:
Facility Name
Lotus Clinical Research, LLC
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Chesapeake Research Group
City
Pasadena
State/Province
Maryland
ZIP/Postal Code
21122
Country
United States
Facility Name
HD Research Corp
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States

12. IPD Sharing Statement

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Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients

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