Herniorrhaphy for Postoperative Pain

A Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of CPL-01 in the Management of Postoperative Pain After Open Inguinal Herniorrhaphy

Subjects receive either CPL-01, positive control, or negative control after herniorrhaphy and are then followed.

Study Overview

• Status: Recruiting
• Conditions: Hernia, Inguinal
• Intervention / Treatment: Drug: local anaesthetic injection

• Study Type: Interventional
• Enrollment (Estimated): 504
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Erol Onel; Phone Number: 2038376500; Email: e.onel@calibiosciences.com

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84101
      • Recruiting
      • Todd Bertoch
      • Contact: Todd Bertoch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Able to sign Informed Consent
• Scheduled to have inguinal hernia repair
• Be a reasonably healthy adult 18 - 75 years of age
• Body mass index ≤ 39 kg/m2
• If biologically female, not pregnant or planning to become pregnant
• If biologically male, using acceptable birth control
• Be willing and able to complete study procedures

Exclusion Criteria:

• Previously inguinal herniorrhaphy
• Concurrent painful condition that may require analgesic treatment
• History or clinical manifestation of significant medical, neuropsychiatric, or other condition, significant abnormal clinical laboratory test value, or known bleeding abnormality that could preclude or impair study participation
• Clinically significant existing arrhythmia, bundle branch block or abnormal ECG, myocardial infarction, or coronary arterial bypass graft surgery within the prior 12 months
• History of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency.
• Impaired liver function (e.g., alanine aminotransferase [ALT] > 3 × upper limit of normal [ULN] or total bilirubin > 2 × ULN), active hepatic disease, or cirrhosis.
• Impaired renal function (e.g., creatinine > 1.5 × ULN).
• Malignancy in the past year
• Known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CPL-01; Local infiltration of CPL-01	Drug: local anaesthetic injection; Local infiltration of study drug
Active Comparator: Ropivacaine HCl; Local infiltration of Naropin	Drug: local anaesthetic injection; Local infiltration of study drug
Placebo Comparator: Placebo; Local infiltration of Saline Placebo	Drug: local anaesthetic injection; Local infiltration of study drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain control	Area under the curve of the numeric rating score for pain with activity, where 0 is no pain and 10 is worst pain imaginable	72 hours

Collaborators and Investigators

• Sponsor: Cali Pharmaceuticals LLC
• Investigators: Study Director: Erol Onel, Cali Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 14, 2023

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Pain, Postoperative; Hernia, Inguinal; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: CPL-01-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No