NCT07490496

Phase 3 Bunionectomy Study

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Cali Pharmaceuticals LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Patients with a bunion will have that repaired and then pain and rescue medicine use will be evaluated.

Detailed 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.

Conditions

• Postoperative Pain
• Bunion

Interventions

Type	Name	Description
DRUG	CPL-01	Administration by the Surgeon during the operation
DRUG	saline placebo	Administration by the Surgeon during the operation

Timeline

• Start date: 2026-07-01
• Primary completion: 2026-10-30
• Completion: 2026-11-28
• First posted: 2026-03-24
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study