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

Postsurgical Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04774328
• Other study ID #: CA-PS-209
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 9, 2020
• Est. completion date: June 15, 2021

Study information

• Verified date: August 2022
• Source: Concentric Analgesics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia, Ventral
• Pain, Postoperative
• Postsurgical Pain

Intervention

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

Locations

Country	Name	City	State
United States	First Surgical Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Concentric Analgesics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 96 hours
Secondary	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.	Up to 96 hours
Secondary	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).	Up to Day 8