Overview
Preliminary Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2022-05-01
2022-05-01
Target enrollment:
0
0
Participant gender:
All
All
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 RepairPhase:
Phase 1/Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Concentric Analgesics
Criteria
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
- 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