NCT05831449

CPL-01 in the Management of Postoperative Pain After Bunionectomy

A Phase 3, Randomized, Double-Blind, Placebo- and Active-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: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 616 (actual)
• Sponsor: Cali Pharmaceuticals LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Subjects receive study drug during bunionectomy and are followed for pain and opioid use, with the hypothesis that those who receive CPL-01 will have less pain and less opioid use than either control arm.

Detailed description

After signing informed consent, subjects will be randomly assigned to receive study drug (either Investigational product, positive control, or negative control) during unilateral distal bunionectomy with osteotomy. Subjects will then remain at the hospital for 72-hours where pain and rescue medication usage will be assessed. Follow-up will then occur at 7 and 30 days afterwards. The hypothesis is that subjects who receive CPL-01 will have less pain and require fewer opioids than subjects in the other two arms.

Conditions

• Bunion

Interventions

Type	Name	Description
DRUG	Local anesthetic injection of CPL-01	Local anesthetic injection (either IP, positive control \[Naropin\], or negative control \[saline placebo\])
DRUG	Naropin, 0.5% Injectable Solution	Local anesthetic injection (either IP, positive control \[Naropin\], or negative control \[saline placebo\])
DRUG	Placebo	Local anesthetic injection (either IP, positive control \[Naropin\], or negative control \[saline placebo\])

Timeline

• Start date: 2023-05-22
• Primary completion: 2025-09-25
• Completion: 2025-10-06
• First posted: 2023-04-26
• Last updated: 2026-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study