CPL-01 for Bunions

Overseen By Erol Onel, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Cali Pharmaceuticals LLC

Disqualifiers: Concomitant conditions

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Todd Bertoch, MD

Principal Investigator

CenExel

Are You a Good Fit for This Trial?

Inclusion Criteria

I have a bunion on my foot.

Exclusion Criteria

Concomitant conditions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Surgery and Initial Recovery

Patients undergo bunion repair surgery under regional anesthesia and stay in the facility for 72 hours for pain and rescue medication assessment

72 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits at 7 days and 30 days

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bunionectomy
• Pain and Rescue Medicine Use Evaluation

How Is the Trial Designed?

Group I: CPL-01 Experimental Treatment 1 Intervention

Intra-operative local administration

Group II: Saline placebo Placebo Group 1 Intervention

Intra-operative local administration

Who Is Running the Clinical Trial?

Cali Pharmaceuticals LLC

Lead Sponsor

Trials

5

Recruited

1,300+