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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-09

Study Completion Date

2021-06-15

Brief Summary

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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

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Detailed Description

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Conditions

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Postsurgical Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CA-008 (vocacapsaicin)

Single administration

Group Type ACTIVE_COMPARATOR

CA-008 (vocacapsaicin)

Intervention Type DRUG

Single administration of CA-008 (vocacapsaicin) versus placebo

Placebo

Single administration

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Single administration of CA-008 (vocacapsaicin) versus placebo

Interventions

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CA-008 (vocacapsaicin)

Single administration of CA-008 (vocacapsaicin) versus placebo

Intervention Type DRUG

Placebo

Single administration of CA-008 (vocacapsaicin) versus placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No