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CPL-01 in the Management of Postoperative Pain After Bunionectomy

NCT05831449 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 616

Last updated 2026-04-30

No results posted yet for this study

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.

Conditions

  • Bunion
  • Post-operative Pain

Interventions

DRUG

Local anesthetic injection of CPL-01

Local anesthetic injection (CPL-01)

DRUG

Naropin, 0.5% Injectable Solution

Local anesthetic injection (positive control \[Naropin\])

DRUG

Placebo

Local anesthetic injection (negative control \[saline placebo\])

DRUG

Morphine rescue medication

Rescue opioid (IV morphine) allowed if requested

DRUG

Acetaminophen rescue medication

Rescue non-opioid (oral acetaminophen) allowed if requested

DRUG

Oxycodone rescue medication

Rescue opioid (PO oxycodone) allowed if requested

PROCEDURE

Bunionectomy

Operative bunion repair

Sponsors & Collaborators

  • Cali Pharmaceuticals LLC

    lead INDUSTRY

Principal Investigators

  • Erol Onel · Cali Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-22
Primary Completion
2025-09-25
Completion
2025-10-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05831449 on ClinicalTrials.gov