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NCT Number: NCT07490496

Phase 3 Bunionectomy Study

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

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Key information

Conditions

Postoperative Pain Bunion Foot Deformities Foot Deformities, Acquired Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

About this study

After signing an informed consent and then appropriate screening and meeting the inclusion and exclusion criteria, patients will have their bunion repaired under regional anesthesia. They will then stay in the facility for 72 hours while pain, rescue medication, and other criteria are assessed. A follow-up visit will occur at 7 days and 30 days after.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Bunion

Exclusion criteria

  • Concomitant conditions

Treatment and study plan

CPL-01

Drug

Administration by the Surgeon during the operation

Saline placebo

Drug

Administration by the Surgeon during the operation

Primary outcomes

  1. Postoperative Pain with activity

    Time frame: 24 hours

    AUC NRS-A wWOCF (Area Under the Curve of the Numeric Rating Scale sore for pain with Activity where 0 is no pain and 10 is worst pain imaginable)

Secondary outcomes

  1. Postoperative Pain with rest

    Time frame: 24 hours, 72 hours

    AUC NRS-R wWOCF (Area Under the Curve of the Numeric Rating Scale sore for pain at Rest where 0 is no pain and 10 is worst pain imaginable)

  2. Postoperative rescue medication use

    Time frame: 24 hours, 72 hours

    Opioid and non-opioid pain control medicines needed

Study contacts

Contact information is provided by the study sponsor or research team.

Erol Onel, MD

CONTACT

[email protected]

203-837-6500

Sponsors and collaborators

Lead sponsor

Cali Pharmaceuticals LLC

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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