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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Postsurgical Pain

In brief

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

Key facts

Study ID

NCT04774328

Run by

Concentric Analgesics

People needed

34

Starts

2020-09-09

Expected to finish

2021-06-15

Last updated by the study team

2022-09-14

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• First Surgical Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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