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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CPL-01, a potential drug, to determine if it can reduce pain and the need for opioids after bunion surgery. Participants will divide into three groups: one receiving CPL-01, another receiving standard pain treatment (ropivacaine), and a third receiving a placebo (inactive substance). The trial aims to determine if CPL-01 can manage pain more effectively than the other options. This trial may suit individuals scheduled for bunion surgery who will not need additional procedures and are free from other painful conditions. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in pain management.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a painful condition that requires treatment, it might affect your eligibility.

Is there any evidence suggesting that CPL-01 is likely to be safe for humans?

Research has shown that CPL-01 is safe and generally well-tolerated. In earlier studies, CPL-01 did not raise any serious safety issues. Patients experienced no increase in unwanted side effects, and the treatment did not interfere with wound healing. Additionally, the extended-release feature of CPL-01 effectively manages pain. This suggests that CPL-01 could be a reliable option for controlling pain after surgery. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for postoperative pain?

Researchers are excited about CPL-01 for postoperative pain because it offers a potentially more effective and targeted approach than existing treatments like local anesthetics and opioid medications. Unlike standard options that generally work by numbing the area or affecting the entire nervous system, CPL-01 is designed for local infiltration at the surgical site, potentially reducing systemic side effects and offering longer-lasting relief. This targeted delivery method aims to provide more consistent pain control and a quicker recovery, which is why it stands out among current postoperative pain management strategies.

What evidence suggests that CPL-01 might be an effective treatment for postoperative pain?

Research has shown that CPL-01, a new long-lasting form of the pain reliever ropivacaine, effectively controls pain after surgery. In this trial, participants may receive CPL-01, which has been found to provide better pain relief than a placebo or other treatments. CPL-01 is safe and well-tolerated, with no increase in side effects. Its special design allows the drug to release steadily over time, leading to better pain control and potentially reducing the need for opioids after surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Erol Onel

Principal Investigator

Cali Biosciences

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11297089/

CPL-01, an investigational long-acting ropivacaine ... Overall, results demonstrated that CPL-01 controlled postoperative pain in a dose-dependent manner, compared to placebo and the active control ...

2. jfas.org jfas.org/article/S1067-2516(24)00223-0/fulltext

Efficacy, safety, and pharmacokinetics of CPL-01, an ... CPL-01 was safe and well-tolerated, with no evidence of increased AEs in one group versus another. Infiltration of CPL-01 had no impact on wound ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05831449

Study Details | NCT05831449 | CPL-01 in the Management ... The hypothesis is that subjects who receive CPL-01 will have less pain and require fewer opioids than subjects in the other two arms. Official Title. A Phase 3, ...

4. link.springer.com link.springer.com/article/10.1007/s40261-025-01419-w

CPL-01, a Novel Extended-Release Ropivacaine ... CPL-01 demonstrates a more predictable and consistent release of ropivacaine over time, in contrast to LB's erratic and biphasic release of bupivacaine.

5. labiotech.eu labiotech.eu/trends-news/cali-biosciences-publishes-ropivacaine-results/

Cali Biosciences publishes ropivacaine results Cali Biosciences Co., Ltd. has announced two milestones for CPL-01, its long-acting ropivacaine for post-operative analgesia and opioid elimination/reduction.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39303759/

Efficacy, safety, and pharmacokinetics of CPL-01, an ... CPL-01 was safe and well-tolerated, with no evidence of increased AEs in one group versus another. Infiltration of CPL-01 had no impact on wound ...