Post-Operative Pain and Opioid Reduction Trial After Bunionectomy

(MERIT-2 Trial)

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

73 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Analgesic Non Narcotic?

Research suggests that non-narcotic pain relievers can effectively reduce the need for narcotic medications and improve patient outcomes, such as faster recovery and reduced side effects, as seen in studies involving postoperative pain management and regional analgesia. ^{1 2 3 4 5}

What safety data exists for Analgesic Non Narcotic treatments?

Regulatory authorities evaluate the safety of non-narcotic analgesics before and after they are marketed, using adverse drug reaction reporting systems to monitor potential risks. However, studies show that adverse event reporting in clinical trials for analgesics is often incomplete, indicating a need for better safety data collection. ^{6 7 8 9 10}

How does the drug Analgesic Non Narcotic differ from other pain treatments?

Analgesic Non Narcotic, like oxapadol, is unique because it provides pain relief without the side effects commonly associated with narcotic painkillers, such as neurological or gastrointestinal issues. It also has anti-inflammatory and fever-reducing properties, making it a versatile option for managing pain. ^{5 11 12 13 14}

What is the purpose of this trial?

This trial tests a new pain relief drug (CPL-01) in patients having bunion surgery. The drug is injected at the end of surgery to help manage pain. Patients will stay in the hospital for a few days for monitoring and return for follow-up visits. The new drug has shown superior pain relief in bunionectomy patients compared to standard care.

Research Team

Erol Onel

Principal Investigator

Cali Biosciences

Eligibility Criteria

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

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

Treatment Details

Interventions

• Analgesic Non Narcotic

Participant Groups

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+

Findings from Research

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Regional analgesia in neonates undergoing thoracoabdominal surgeries: A pilot study. [2019]

2. Canada pubmed.ncbi.nlm.nih.gov

Simple frameshifts in minimally invasive surgery postoperative pain management significantly reduce opiate prescriptions. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Patient-controlled analgesia. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Non-opioid analgesics as adjuvants to opioid for pain management in adult patients in the ICU: A systematic review and meta-analysis. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Analgesic effectiveness of dipyrone (metamizol) for postoperative pain after herniorrhaphy: a randomized, double-blind, dose-response study. [2015]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Regulatory decisions and consumers. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

The comparative safety of analgesics in older adults with arthritis. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse Event Reporting in Clinical Trials of Intravenous and Invasive Pain Treatments: An ACTTION Systematic Review. [2018]

9. Canada pubmed.ncbi.nlm.nih.gov

Retrospective analysis of opioid medication incidents requiring administration of naloxone. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Analgesic activity of diflunisal [MK-647; 5-(2,4-difluorophenyl)salicylic acid] in rats with hyperalgesia induced by Freund's adjuvant. [2013]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Animal pharmacology of oxapadol (MD 720111), a new non-narcotic analgesic. [2019]

13. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Postoperative analgesia with nonsteroid anti-inflammatory drugs in children]. [2013]

14. England pubmed.ncbi.nlm.nih.gov

Oral narcotic analgesics. Choosing the most appropriate agent for acute pain. [2019]