Status:
COMPLETED
Preliminary Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair
Lead Sponsor:
Concentric Analgesics
Conditions:
Postsurgical Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- Concurrent condition requiring analgesic treatment during study period
- Opioid tolerant
- Known allergy to capsaicin or other study medication
- Use of prohibited medications
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04774328
Start Date
September 9 2020
End Date
June 15 2021
Last Update
September 14 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
First Surgical Hospital
Houston, Texas, United States, 77004