CPL-01 for Inguinal Hernia Repair

No longer recruiting at 4 trial locations

Overseen By Lee Chen, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cali Pharmaceuticals LLC

Must not be taking: Antidepressants, Benzodiazepines, Antiarrhythmics, others

Disqualifiers: Herniorrhaphy history, Liver impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 72 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to manage pain after open inguinal hernia repair, a common surgery for hernias in the lower abdomen. The study compares different doses of an experimental treatment, CPL-01, with a standard pain medication, Naropin, and a placebo (a substance with no active drug). People planning to undergo this type of hernia surgery and who are generally healthy might be suitable for this trial. Participants should not have had previous hernia surgery or major health issues that could affect their participation. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as specific pain medications and supplements, before and during the study. However, if you are taking medications for non-pain reasons and the dose has been stable for at least 30 days, you may continue them. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found CPL-01 to be safe and well-tolerated, with no major safety concerns reported. The treatment consistently released its effects, showing promise for managing post-surgical pain.

Naropin has been used safely for a long time. Similar to other pain-numbing drugs, it is generally well-tolerated. Some side effects, akin to those seen with similar drugs, might occur, but patients have generally handled it well in clinical settings.

Both CPL-01 and Naropin have demonstrated good safety records, suggesting they are likely safe options for managing pain after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about CPL-01 for postoperative pain management because it offers a new approach with its dose escalation strategy, allowing for personalized pain relief by adjusting doses from 200mg to 600mg. Unlike standard treatments like Naropin (ropivacaine), which mainly focus on blocking nerve signals, CPL-01 may provide longer-lasting pain relief by potentially targeting pain pathways more effectively. This could mean fewer doses and less reliance on additional medications, making recovery smoother for patients after surgeries like inguinal hernia repairs.

What evidence suggests that this trial's treatments could be effective for inguinal herniorrhaphy?

This trial will compare CPL-01 and Naropin, both forms of ropivacaine, in managing post-surgical pain. Studies have shown that CPL-01, a long-lasting form of ropivacaine, effectively manages pain and reduces the need for opioids, which are strong painkillers with potential side effects. Research indicates that CPL-01's pain control depends on the dose, with higher doses providing better relief. Naropin, another treatment option in this trial, has already proven effective for managing post-surgical pain. It has been safely used in surgeries to reduce pain and improve patient comfort. Both treatments have a history of aiding patients in managing post-surgical pain. ^{2 3 4 6 7}

Who Is on the Research Team?

Erol Onel, MD

Principal Investigator

Cali Biosciences

Are You a Good Fit for This Trial?

Inclusion Criteria

Be willing and able to sign the informed consent form (ICF) prior to study participation.

Plan to undergo an elective open inguinal herniorrhaphy with mesh under general anesthesia without collateral procedures or additional surgeries. Endotracheal intubation is not required.

Have a body mass index ≤ 39 kg/m2.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive CPL-01 or placebo or Naropin for postoperative pain management

72 hours

Inpatient stay for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Dose Expansion (optional)

Optional phase to further evaluate safety and efficacy at expanded doses

What Are the Treatments Tested in This Trial?

Interventions

• CPL-01
• Naropin 150 MG Per 20 ML Injection
• Placebo

How Is the Trial Designed?

Group I: Placebo Experimental Treatment 1 Intervention

30mL normal saline (0.9%)

Group II: Naropin Experimental Treatment 1 Intervention

150mg

Group III: CPL-01 Experimental Treatment 1 Intervention

CPL-01 200mg, 400mg, 600mg

Who Is Running the Clinical Trial?

Cali Pharmaceuticals LLC

Lead Sponsor

Trials

5

Recruited

1,300+

Published Research Related to This Trial

In a study of 142 children who accidentally received injections of trimedoxime (TMB4) and atropine, only a small percentage experienced mild side effects, such as dilated pupils and dryness of mucous membranes, indicating a relatively safe profile even with higher-than-recommended doses.

Children who received doses exceeding the recommended amount were more likely to show symptoms, but overall, the lack of severe side effects suggests that unintentional injections of these medications may not pose significant health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric poisoning from trimedoxime (TMB4) and atropine automatic injectors. Kozer, E., Mordel, A., Haim, SB., et al.[2013]

In a study of 84 children aged 30 months to 15 years taking oxybutynin chloride (Ditropan), 52 experienced atropinic symptoms, indicating a high incidence of side effects, particularly in younger patients.

The frequency of side effects was found to be four times higher in children compared to adults, suggesting that dosage and metabolic differences may contribute to this increased risk, leading to new recommendations for its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse effects of oxybutynin chloride (Ditropan) in pediatrics]. Jonville, AP., Dutertre, JP., Barbellion, M., et al.[2013]

Citations

1.

pmc.ncbi.nlm.nih.gov

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

CPL-01, an investigational long-acting ropivacaine ...

CPL-01, an investigational long-acting ropivacaine, demonstrates safety and efficacy in open inguinal hernia repair · Background. Effective ...

2.

jfas.org

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

Efficacy, safety, and pharmacokinetics of CPL-01, an ...

CPL-01 (ropivacaine extended-release injection) is formulated to safely provide postoperative analgesia and reduce opioid use.

3.

pubmed.ncbi.nlm.nih.gov

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

Efficacy, safety, and pharmacokinetics of CPL-01, an ...

CPL-01 (ropivacaine extended-release injection) is formulated to safely provide postoperative analgesia and reduce opioid use.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S002235652416956X

CPL-01, A Novel Extended-Release Ropivacaine ...

Superior Capsular Reconstruction Using Dermal Allograft Is a Safe and Effective Treatment for Massive Irreparable Rotator Cuff Tears: 2-Year Clinical Outcomes.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05831449

Study Details | NCT05831449 | CPL-01 in the Management ...

There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial information ...

6.

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.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S1067251624002230

Efficacy, safety, and pharmacokinetics of CPL-01, an ...

CPL-01 (ropivacaine extended-release injection) is formulated to safely provide postoperative analgesia and reduce opioid use.