Study detail
RecruitingPhase 3
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of CPL-01 in the Management of Postoperative Pain After Unilateral Distal First Metatarsal Bunionectomy With Osteotomy
Cali Pharmaceuticals LLC
Summary
Patients with a bunion will have that repaired and then pain and rescue medicine use will be evaluated.
Description
After signing an informed consent and then appropriate screening and meeting the inclusion and exclusion criteria, patients will have their bunion repaired under regional anesthesia. They will then stay in the facility for 72 hours while pain, rescue medication, and other criteria are assessed. A follow-up visit will occur at 7 days and 30 days after.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Detailed criteria
Inclusion Criteria: * Bunion Exclusion Criteria: * Concomitant conditions
Interventions
- DrugCPL-01
Administration by the Surgeon during the operation
- Drugsaline placebo
Administration by the Surgeon during the operation
Location
- CenExelSalt Lake City, Utah