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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04774328
Recruitment Status : Completed
First Posted : March 1, 2021
Results First Posted : September 14, 2022
Last Update Posted : September 14, 2022
Sponsor:
Information provided by (Responsible Party):
Concentric Analgesics

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
Postsurgical Pain Drug: CA-008 (vocacapsaicin) Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
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 : September 9, 2020
Actual Primary Completion Date : June 15, 2021
Actual Study Completion Date : June 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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




Primary Outcome Measures :
  1. Pain at Rest - Part B [ Time Frame: Up to 96 hours ]
    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 :
  1. Evoked NRS - Part B [ Time Frame: Up to 96 hours ]

    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.


  2. Opioid Consumption - Part B [ Time Frame: Up to Day 8 ]
    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).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT04774328


Locations
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United States, Texas
First Surgical Hospital
Houston, Texas, United States, 77004
Sponsors and Collaborators
Concentric Analgesics
Investigators
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Principal Investigator: Daneshvari Solanki, MD First Surgical Hospital
  Study Documents (Full-Text)

Documents provided by Concentric Analgesics:
Study Protocol  [PDF] March 15, 2021
Statistical Analysis Plan  [PDF] May 14, 2021

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Responsible Party: Concentric Analgesics
ClinicalTrials.gov Identifier: NCT04774328    
Other Study ID Numbers: CA-PS-209
First Posted: March 1, 2021    Key Record Dates
Results First Posted: September 14, 2022
Last Update Posted: September 14, 2022
Last Verified: August 2022

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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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Hernia, Ventral
Pain, Postoperative
Hernia
Pathological Conditions, Anatomical
Hernia, Abdominal
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations