NCT05411861

Post-Operative Pain and Opioid Reduction Trial After Bunionectomy

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Cali Pharmaceuticals LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hallux Valgus and Bunion

Interventions

Type	Name	Description
DRUG	Analgesic Non Narcotic	Injection of protocol-specified volume of local analgesic

Timeline

• Start date: 2022-06-14
• Primary completion: 2022-09-26
• Completion: 2022-11-07
• First posted: 2022-06-09
• Last updated: 2023-01-11

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study