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Preliminary Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair

Sponsor
Concentric Analgesics (Industry)
Overall Status
Completed
CT.gov ID
NCT04774328
Collaborator
(none)
34
Enrollment
1
Location
2
Arms
4.1
Actual Duration (Months)
8.3
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: CA-008 (vocacapsaicin)
  • Drug: Placebo
 Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 10, 2021
Actual Primary Completion Date :
Jun 15, 2021
Actual Study Completion Date :
Jun 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: CA-008 (vocacapsaicin)

Single administration

Drug: CA-008 (vocacapsaicin)
Single administration of CA-008 (vocacapsaicin) versus placebo
Placebo Comparator: Placebo

Single administration

Drug: Placebo
Single administration of CA-008 (vocacapsaicin) versus placebo

Outcome Measures

Primary Outcome Measures

  1. Pain Intensity Scores [Up through 96 hours]

    None in Parts A and B; In Part C, 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 the first 96 hours for CA-008

Secondary Outcome Measures

  1. Opioid Consumption [Up through 96 hours]

    None in Parts A and B; In Part C, total opioid consumption converted to an oral morphine equivalent dose over 96 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 First Surgical Hospital Houston Texas United States 77004

Sponsors and Collaborators

  • Concentric Analgesics

Investigators

  • Principal Investigator: Daneshvari Solanki, MD, First Surgical Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Concentric Analgesics
ClinicalTrials.gov Identifier:
NCT04774328
Other Study ID Numbers:
  • CA-PS-209
First Posted:
Mar 1, 2021
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hernia, Ventral
Pain, Postoperative

Study Results

No Results Posted as of Mar 25, 2022