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

Phase 1

Completed

• Conditions: Postsurgical Pain
• Interventions: Drug: Placebo; Drug: CA-008 (vocacapsaicin)

• Registration Number: NCT04774328
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-09
• Study First Submitted: 2021-02-24
• Study First Submitted QC: 2021-02-24
• Study First Posted: 2021-03-01
• Primary Completion: 2021-06-15
• Study Completion: 2021-06-15
• Results First Submitted: 2022-06-10
• Status Verified: 2022-08
• Results First Submitted QC: 2022-08-19
• Last Update Submitted: 2022-08-19
• Results First Posted: 2022-09-14
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Single administration
CA-008 (vocacapsaicin)	CA-008 (vocacapsaicin)	Single administration

Primary Outcome Measures

Name	Time	Method
Pain at Rest - Part B	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

Name	Time	Method
Evoked NRS - Part B	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.
Opioid Consumption - Part B	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).

Trial Locations

Locations (1)

First Surgical Hospital; 🇺🇸 Houston, Texas, United States