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NOT YET RECRUITING

NCT07490496

PHASE3

Phase 3 Bunionectomy Study

Sponsor: Cali Pharmaceuticals LLC

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

112

Start Date

2026-07-01

Completion Date

2026-11-28

Last Updated

2026-03-27

Healthy Volunteers

Conditions

Postoperative Pain Bunion

Interventions

DRUG

CPL-01

Administration by the Surgeon during the operation

DRUG

saline placebo

Administration by the Surgeon during the operation

Locations (1)

CenExel

Salt Lake City, Utah, United States