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

NCT04774328 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CA-PS-209
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Postsurgical Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evoked NRS - Part B

  Up to 96 hours

• Opioid Consumption - Part B

  Up to Day 8

Study Arms (2)

CA-008 (vocacapsaicin)

ACTIVE COMPARATOR

Single administration

Drug: CA-008 (vocacapsaicin)

Placebo

PLACEBO COMPARATOR

Single administration

Drug: Placebo

Interventions

CA-008 (vocacapsaicin) DRUG

Single administration of CA-008 (vocacapsaicin) versus placebo

CA-008 (vocacapsaicin)

Placebo DRUG

Single administration of CA-008 (vocacapsaicin) versus placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Concurrent condition requiring analgesic treatment during study period
• Opioid tolerant
• Known allergy to capsaicin or other study medication
• Use of prohibited medications

Sponsors & Collaborators

• Concentric Analgesics: lead

Study Sites (1)

First Surgical Hospital

Houston, Texas, 77004, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Carrie Khouri, Associate Director of Clinical Operations
• Organization: Concentric Analgesics

ckhouri@concentricanalgesics.com

1-415-484-7921

Study Officials

• Daneshvari Solanki, MD

  First Surgical Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 1, 2021
• Study Start: September 9, 2020
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: September 14, 2022
• Results First Posted: September 14, 2022

Record last verified: 2022-08

Locations

US (1)