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CPL-01 for Inguinal Hernia Repair

Phase 2
Waitlist Available
Research Sponsored by Cali Pharmaceuticals LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 - 72 hours
Awards & highlights

Summary

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.

Eligible Conditions
  • Inguinal Hernia Repair

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 - 72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 - 72 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AUC of the NRS-A for pain (Primary Endpoint)

Side effects data

From 2020 Phase 2 trial • 20 Patients • NCT04182880
27%
Constipation
20%
Nausea
7%
Feeling Hot
7%
Hypoaesthesia
7%
Dizziness
7%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
CPL-01

Trial Design

3Treatment groups
Experimental Treatment
Group I: PlaceboExperimental Treatment1 Intervention
30mL normal saline (0.9%)
Group II: NaropinExperimental Treatment1 Intervention
150mg
Group III: CPL-01Experimental Treatment1 Intervention
CPL-01 200mg, 400mg, 600mg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CPL-01
2020
Completed Phase 2
~130
Naropin 150 MG Per 20 ML Injection
2021
Completed Phase 2
~110
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Cali Pharmaceuticals LLCLead Sponsor
4 Previous Clinical Trials
1,171 Total Patients Enrolled
Erol Onel, MDStudy ChairCali Biosciences
5 Previous Clinical Trials
620 Total Patients Enrolled
~26 spots leftby Sep 2025
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