CPL-01 for Postoperative Pain

Overseen By Erol Onel

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Cali Pharmaceuticals LLC

Must not be taking: Opioids

Disqualifiers: Concurrent painful condition, Liver impairment, Renal impairment, others

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

Duration: 72 hours

574 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Erol Onel

Principal Investigator

Cali Biosciences

Eligibility Criteria

This trial is for adults with bunions requiring surgery who can consent to the study. They must have a BMI ≤ 39, not be pregnant or planning pregnancy, and if male, use birth control. Excluded are those with other painful conditions, significant health issues that could affect participation, liver or kidney impairments, recent cancer history, past bunionectomy or daily opioid use within six months.

Inclusion Criteria

I am willing and able to follow the study's procedures.

I am a man who is either sterile or using reliable birth control.

I am not pregnant nor planning to become pregnant during the study.

Exclusion Criteria

I have a painful condition that might affect pain assessments in the study.

I do not have any major health or mental issues that could affect my participation in the study.

I have a history of malignant hyperthermia or G6PD deficiency.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the study drug during unilateral distal bunionectomy with osteotomy and remain at the hospital for 72 hours for pain and rescue medication assessment

72 hours

In-hospital stay

Follow-up

Participants are monitored for pain and opioid use at 7 and 30 days post-treatment

30 days

2 visits (in-person)

Treatment Details

Interventions

• CPL-01

Trial Overview The trial tests CPL-01's effectiveness in managing postoperative pain after bunion surgery compared to Naropin and placebo. The goal is to see if CPL-01 reduces pain and opioid consumption more effectively than the controls following surgery.

Participant Groups

Group I: CPL-01 Experimental Treatment 1 Intervention

Local infiltration of study drug

Group II: Ropivacaine HCl Active Control 1 Intervention

Local infiltration of study drug

Group III: Placebo Placebo Group 1 Intervention

Local infiltration of study drug

Who Is Running the Clinical Trial?

Cali Pharmaceuticals LLC

Lead Sponsor

Trials

5

Recruited

1,300+