For Healthcare Professionals

Herniorrhaphy for Postoperative Pain

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About the study

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

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


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

EXCLUSION CRITERIA

Exclusion Criteria:


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

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 2038376500Email iconEmail Study Center

Study Details


Contition

Hernia, Inguinal

Age

18 - 75

Phase

PHASE3

Participants Needed

504

Est. Completion Date

Dec 31, 2024

Treatment Type

INTERVENTIONAL


Sponsor

Cali Pharmaceuticals LLC

ClinicalTrials.gov NCT Identifier

NCT05813847

Study Number

CPL-01-301

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