drugset / Trial / NCT05831449

CPL-01 in the Management of Postoperative Pain After Bunionectomy

NCT05831449

Phase 3 Completed 616 enrolled Cali Pharmaceuticals LLC
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2023-05-22
Primary completion
2025-09-25
Completion
2025-10-06

Drugs

EvaluationDrugModalityDoseRoute
Subject CPL-01 Unknown Other
Comparator Ropivacaine Other / unclassified 0.5 % Other
Background Acetaminophen Small molecule Oral
Background Morphine Other / unclassified Intravenous
Background Oxycodone Other / unclassified Oral

Indications