Post-Operative Pain and Opioid Reduction Trial After Bunionectomy — MERIT-2  

Hallux Valgus and Bunion Clinical Trial

Official title: Randomized, Double-Blind, Placebo- and Active-Controlled, Dose Escalation and Optional Dose Expansion Study to Evaluate Safety, Efficacy, and PK of CPL-01 in Post-Op Pain After Unilateral Distal First Metatarsal Bunionectomy + Osteotomy

Status Completed

Clinical Trial Summary

This is a Phase 2b, randomized, double blind, placebo and active controlled study with an Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing bunionectomy.

Clinical Trial Description

Near the completion of surgery, a single dose of study drug (CPL-01, saline placebo, or ropivacaine HCl) will be infiltrated. Subjects will remain in the hospital/research facility for a minimum of 72 hours after the start of study drug administration to undergo postoperative assessments. Subjects will return to the study site on Day 7 to complete follow up assessments, on Day 28 for follow-up assessments including an X-Ray, and on Day 42 for the end-of-study (EOS) visit. ;

Related Conditions & MeSH terms

• Hallux Valgus
• Hallux Valgus and Bunion

• NCT number: NCT05411861
• Study type: Interventional
• Source: Cali Pharmaceuticals LLC
• Status: Completed
• Phase: Phase 2
• Start date: June 14, 2022
• Completion date: November 7, 2022