Herniorrhaphy for Postoperative Pain

Completed · Phase 3 · Has a placebo group

Conditions studied: Hernia, Inguinal, Post Operative Pain

In brief

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

Key facts

Study ID

NCT05813847

Run by

Cali Pharmaceuticals LLC

People needed

518

Starts

2023-04-18

Expected to finish

2025-10-06

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Todd Bertoch — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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