RECRUITING

Herniorrhaphy for Postoperative Pain

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-04-18

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05813847

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Erol Onel

CONTACT

2038376500

e.onel@calibiosciences.com

Principal Investigator

Erol Onel

STUDY_DIRECTOR

Cali Biosciences

Study Locations (Sites)

Todd Bertoch

Salt Lake City, Utah, 84101

United States

Collaborators and Investigators

Sponsor: Cali Pharmaceuticals LLC

Erol Onel, STUDY_DIRECTOR, Cali Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-18

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-04-18

Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

Hernia, Inguinal