A Phase 2, Randomized, Double-Blind, Dose Escalation Study in Postoperative Pain Open Inguinal Herniorrhaphy

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

105 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Naropin in the clinical trial?

Research shows that Naropin, when used in small doses for continuous epidural infusion, is highly effective in reducing pain after surgery, with most patients experiencing little to no pain. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

The treatment, which includes atropine, has been studied for safety in various contexts. Atropine can cause side effects similar to an overdose, especially in children, with symptoms mainly affecting the nervous system and eyes. Adjusting the dose for children is important to avoid these side effects. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial tests a new medication called CPL-01 to help manage pain in patients having open inguinal hernia repair surgery. Different doses are being tried to find the safest and most effective one.

Research Team

Erol Onel, MD

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 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

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

Treatment Details

Interventions

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

Participant Groups

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+

Findings from Research

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]

References

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

Effect of methylprednisolone on naloxone's hemodynamic response in canine hypovolemic shock. [2019]

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

Late administration of methylprednisolone does not enhance naloxone effect in hypovolemic shock. [2013]

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

Treatment of acute spinal cord injury with methylprednisolone: results of a multicenter, randomized clinical trial. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Effects of pethidine and its antagonists on the newborn. [2019]

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

[Continuous epidural infusion of ropivacaine hydrochloride (naropin) during postoperative analgesia in cardiosurgical patients]. [2018]

6. Slovakia pubmed.ncbi.nlm.nih.gov

Protective efficacy of 2-PAMCl, atropine and curcumin against dichlorvos induced toxicity in rats. [2021]

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

Clinical and bioavailability studies of sublingually administered atropine sulfate. [2013]

8. France pubmed.ncbi.nlm.nih.gov

[Adverse effects of oxybutynin chloride (Ditropan). Evaluation of the official survey of Regional Pharmacovigilance Centers]. [2013]

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

Pediatric poisoning from trimedoxime (TMB4) and atropine automatic injectors. [2013]

10. France pubmed.ncbi.nlm.nih.gov

[Adverse effects of oxybutynin chloride (Ditropan) in pediatrics]. [2013]