CPL-01 for Inguinal Hernia Repair
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.12345Why 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.23467
Who Is on the Research Team?
Erol Onel, MD
Principal Investigator
Cali Biosciences
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CPL-01 or placebo or Naropin for postoperative pain management
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cali Pharmaceuticals LLC
Lead Sponsor