Analgesic for Pain After Bunion Correction

(MERIT-2 Trial)

No longer recruiting at 2 trial locations

Overseen By Erol Onel

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cali Pharmaceuticals LLC

Disqualifiers: Concurrent painful condition, Impaired liver, Renal function, others

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

Compensation: Varies

Number of Visits: 75

Duration: 72 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new non-narcotic pain reliever to reduce post-surgery pain after bunion surgery. Researchers aim to determine if this new treatment, CPL-01, can manage pain effectively without opioids, which carry addiction risks. Participants will receive either a placebo (a harmless pill with no active drug), a dose of Ropivacaine HCl (a standard pain medication), or the experimental drug CPL-01 (an analgesic non-narcotic). This trial suits those planning straightforward bunion surgery who are generally healthy, without other painful conditions or planned additional surgeries. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

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

Research has shown that both Ropivacaine HCl and CPL-01 have been safe in previous studies.

Ropivacaine HCl is already used in medical practice. It is generally safe, but some risks exist, such as potential heart issues if it accidentally enters a vein, along with side effects like dizziness and nausea.

CPL-01, a long-acting version of Ropivacaine, has also been tested and found safe, with no major safety concerns. It provides longer-lasting pain relief, which may reduce the need for strong pain medications like opioids after surgery.

Overall, both treatments have demonstrated safety, but awareness of potential side effects is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about CPL-01 because it offers a non-narcotic alternative for managing post-operative pain after a bunionectomy. Unlike traditional opioid treatments, which can have addictive properties and unpleasant side effects, CPL-01 is designed to provide effective pain relief without these risks. This experimental drug targets pain through a unique mechanism that doesn't involve the opioid pathways, potentially leading to safer pain management options. Additionally, CPL-01's non-narcotic nature could significantly reduce the reliance on opioids, addressing a critical need in pain management today.

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

Studies have shown that Ropivacaine HCl, one of the treatments in this trial, serves as an effective anesthetic for surgery and helps manage postoperative pain. It reduces the need for opioids by providing effective pain relief. CPL-01, another treatment option in this trial, is a new, long-lasting version of ropivacaine. Research indicates that CPL-01 controls pain well after surgery, with many patients not requiring opioids for the first three days. CPL-01 releases the drug more steadily over time, simplifying pain management. Both treatments show promise for managing pain after bunion surgery. ^{1 2 4 6 7}

Who Is on the Research Team?

Erol Onel

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 primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries

Have a BMI ≤ 39 kg/m2

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

A single dose of study drug (CPL-01, saline placebo, or ropivacaine HCl) is administered near the completion of surgery, followed by a minimum 72-hour hospital stay for postoperative assessments

72 hours

In-hospital stay for 72 hours

Follow-up

Participants return for follow-up assessments on Day 7, Day 28 (including an X-Ray), and Day 42 for the end-of-study visit

42 days

3 visits (in-person)

Optional Dose Expansion

An optional phase for dose expansion to further evaluate safety and efficacy

What Are the Treatments Tested in This Trial?

Interventions

• Analgesic Non Narcotic

How Is the Trial Designed?

Group I: CPL-01 Experimental Treatment 1 Intervention

Low dose of CPL-01

Group II: Ropivacaine HCl Active Control 1 Intervention

Low dose of Ropivacaine HCl

Group III: Placebo Placebo Group 1 Intervention

Low volume of placebo

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 Medicare beneficiaries averaging 80 years old, opioids were found to have a significantly higher risk of cardiovascular events and all-cause mortality compared to nonselective NSAIDs (nsNSAIDs).

Coxibs showed a reduced risk of gastrointestinal bleeding compared to nsNSAIDs, but both coxibs and nsNSAIDs had similar fracture risks, while opioids were associated with a much higher fracture risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The comparative safety of analgesics in older adults with arthritis. Solomon, DH., Rassen, JA., Glynn, RJ., et al.[2022]

A systematic review of adverse event (AE) reporting in clinical trials of intravenous and invasive pain treatments revealed no significant improvement in reporting quality since the 2004 CONSORT guidelines, with only 5 out of 10 reporting standards met on average.

Overall, 8% of the articles reviewed did not report any AE information, highlighting a critical need for better transparency and adherence to reporting standards in clinical trials to fully understand the risks associated with pain treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Event Reporting in Clinical Trials of Intravenous and Invasive Pain Treatments: An ACTTION Systematic Review. Williams, MR., McKeown, A., Pressman, Z., et al.[2018]

A systematic review of 80 randomized controlled trials (RCTs) on noninvasive analgesic treatments revealed that adverse event (AE) reporting was often incomplete, with over 40% of trials not reporting any serious adverse events.

The review highlighted that trials involving participants with pain conditions and those sponsored by industry provided better AE data, indicating a need for improved consistency and thoroughness in AE reporting across all analgesic RCTs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations. Smith, SM., Wang, AT., Katz, NP., et al.[2023]

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. 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.

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

CPL-01, A Novel Extended-Release Ropivacaine ... Conclusions: Consistent median Tmax values across surgical models with CPL-01 indicates a more predictable release of ropivacaine over time across multiple ...

5. biospace.com biospace.com/cali-biosciences-announces-successful-results-in-phase-iib-study-of-long-acting-ropivacaine-cpl-01-for-non-opioid-treatment-of-post-operative-pain

Cali Biosciences Announces Successful Results in Phase ... In fact, approximately 2/3 of the CPL-01 subjects (9/14) required no opioids at all after the first 72 hours after the operation, compared to ...

6. 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.

7. 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, ...