Preliminary Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair
Primary Purpose
Postsurgical Pain
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CA-008 (vocacapsaicin)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postsurgical Pain
Eligibility Criteria
Inclusion Criteria:
- Scheduled elective, primary, open laparotomy with VHR, with retromuscular, preperitoneal mesh placement, with midline fascial reconstruction
- ASA physical class 1, 2, or 3
- BMI </= 40 kg/m2
- Aged 18-80 years old
Exclusion Criteria:
- Concurrent condition requiring analgesic treatment during study period
- Opioid tolerant
- Known allergy to capsaicin or other study medication
- Use of prohibited medications
Sites / Locations
- First Surgical Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
CA-008 (vocacapsaicin)
Placebo
Arm Description
Single administration
Single administration
Outcomes
Primary Outcome Measures
Pain at Rest - Part B
Pain at rest measured by a Numeric Rating Scale (NRS) from time 0 to 96 hours (AUC 0-96). NRS pain scores at rest were collected at 1, 2, 4, 6, 8, 12, 16, 20, 24 and every 4 hours there after post the time of entry into the PACU (while the patient is awake), until discharge from the inpatient until at 96 hour. NRS area under the curve (AUC) is the weighted sum of current pain intensity assessments for a specified time interval. The NRS ranks pain from 0-10; zero being no pain present and 10 being the worst possible pain. Other than 0 and 10, no other pain ratings (2-9) were labeled.
Secondary Outcome Measures
Evoked NRS - Part B
Evoked NRS pain scores (three maneuvers: coughing, sitting up, walking) from time 0-96 hours. Evoked NRS scores were obtained twice daily in the morning at 10:00AM (± 1h) and in the afternoon at 4:00PM (±1 h).
NRS area under the curve (AUC) is the weighted sum of current pain intensity assessments for a specified time interval. The NRS ranks pain from 0-10; zero being no pain present and 10 being the worst possible pain. Other than 0 and 10, no other pain ratings (2-9) were labeled.
Opioid Consumption - Part B
Total opioid consumption (OC) converted to an oral morphine equivalent (OME) dose from 0 to 96 hours (OC 0-T96) and 0 to Day 8 (OC 0-D8).
Full Information
NCT ID
NCT04774328
First Posted
February 24, 2021
Last Updated
August 19, 2022
Sponsor
Concentric Analgesics
1. Study Identification
Unique Protocol Identification Number
NCT04774328
Brief Title
Preliminary Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair
Official Title
A Three-Part, Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Adaptive Safety, Pharmacokinetics, and Preliminary Efficacy Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
June 15, 2021 (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
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Three-Part, Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Adaptive Safety, Pharmacokinetics, and Preliminary Efficacy Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postsurgical Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CA-008 (vocacapsaicin)
Arm Type
Active Comparator
Arm Description
Single administration
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single administration
Intervention Type
Drug
Intervention Name(s)
CA-008 (vocacapsaicin)
Intervention Description
Single administration of CA-008 (vocacapsaicin) versus placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single administration of CA-008 (vocacapsaicin) versus placebo
Primary Outcome Measure Information:
Title
Pain at Rest - Part B
Description
Pain at rest measured by a Numeric Rating Scale (NRS) from time 0 to 96 hours (AUC 0-96). NRS pain scores at rest were collected at 1, 2, 4, 6, 8, 12, 16, 20, 24 and every 4 hours there after post the time of entry into the PACU (while the patient is awake), until discharge from the inpatient until at 96 hour. NRS area under the curve (AUC) is the weighted sum of current pain intensity assessments for a specified time interval. The NRS ranks pain from 0-10; zero being no pain present and 10 being the worst possible pain. Other than 0 and 10, no other pain ratings (2-9) were labeled.
Time Frame
Up to 96 hours
Secondary Outcome Measure Information:
Title
Evoked NRS - Part B
Description
Evoked NRS pain scores (three maneuvers: coughing, sitting up, walking) from time 0-96 hours. Evoked NRS scores were obtained twice daily in the morning at 10:00AM (± 1h) and in the afternoon at 4:00PM (±1 h).
NRS area under the curve (AUC) is the weighted sum of current pain intensity assessments for a specified time interval. The NRS ranks pain from 0-10; zero being no pain present and 10 being the worst possible pain. Other than 0 and 10, no other pain ratings (2-9) were labeled.
Time Frame
Up to 96 hours
Title
Opioid Consumption - Part B
Description
Total opioid consumption (OC) converted to an oral morphine equivalent (OME) dose from 0 to 96 hours (OC 0-T96) and 0 to Day 8 (OC 0-D8).
Time Frame
Up to Day 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Scheduled elective, primary, open laparotomy with VHR, with retromuscular, preperitoneal mesh placement, with midline fascial reconstruction
ASA physical class 1, 2, or 3
BMI </= 40 kg/m2
Aged 18-80 years old
Exclusion Criteria:
Concurrent condition requiring analgesic treatment during study period
Opioid tolerant
Known allergy to capsaicin or other study medication
Use of prohibited medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daneshvari Solanki, MD
Organizational Affiliation
First Surgical Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Surgical Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Preliminary Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair
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