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

Concentric Analgesics

Status and phase: Completed; Phase 2; Phase 1

Conditions: Postsurgical Pain

Treatments: Drug: CA-008 (vocacapsaicin); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04774328

CA-PS-209

Details and patient eligibility

About

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

Enrollment: 34 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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34 participants in 2 patient groups, including a placebo group

CA-008 (vocacapsaicin)

Active Comparator group

Description:

Single administration

Treatment:

Drug: CA-008 (vocacapsaicin)

Placebo

Placebo Comparator group

Description:

Single administration

Treatment:

Drug: Placebo