NCT07490496

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P25-P50 for phase_3 postoperative-pain

Timeline
5mo left

Started Jul 2026

Shorter than P25 for phase_3 postoperative-pain

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2026

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

4 months

First QC Date

March 16, 2026

Last Update Submit

March 23, 2026

Conditions

Postoperative PainBunion

Keywords

bunionectomybunionosteotomy

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain with activity

    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)

    24 hours

Secondary Outcomes (2)

  • Postoperative Pain with rest

    24 hours, 72 hours

  • Postoperative rescue medication use

    24 hours, 72 hours

Study Arms (2)

CPL-01

EXPERIMENTAL

Intra-operative local administration

Drug: CPL-01

Saline placebo

PLACEBO COMPARATOR

Intra-operative local administration

Drug: saline placebo

Interventions

CPL-01DRUG

Administration by the Surgeon during the operation

CPL-01
saline placeboDRUG

Administration by the Surgeon during the operation

Saline placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bunion

You may not qualify if:

  • Concomitant conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CenExel

Salt Lake City, Utah, 84107, United States

Location

Related Publications (1)

  • Xu HT, Zimmerman J, Bertoch T, Chen L, Chen PJ, Onel E. Efficacy, safety, and pharmacokinetics of CPL-01, an investigational long-acting ropivacaine, in bunionectomy: Results of a phase 2b study. J Foot Ankle Surg. 2025 Mar-Apr;64(2):150-156. doi: 10.1053/j.jfas.2024.09.007. Epub 2024 Sep 19.

    PMID: 39303759BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeBunion

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal Diseases

Study Officials

  • Todd Bertoch, MD

    CenExel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Erol Onel, MD

CONTACT

203-837-6500e.onel@calibiosciences.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Bunionectomy
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 24, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

November 28, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

All IPD necessary for results

Shared Documents
STUDY PROTOCOL
Time Frame
After approval
Access Criteria
As necessary

Locations

US(1)