RECRUITING

CPL-01 in the Management of Postoperative Pain After Bunionectomy

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 study drug during bunionectomy and are followed for pain and opioid use, with the hypothesis that those who receive CPL-01 will have less pain and less opioid use than either control arm.

Official Title

A Phase 3, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of CPL-01 in the Management of Postoperative Pain After Unilateral Distal First Metatarsal Bunionectomy With Osteotomy

Quick Facts

Study Start:2023-05-22

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05831449

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
* Ability to sign ICF * Bunion for elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries * BMI ≤ 39 kg/m2 * If biologically female, not pregnant or planning to become pregnant over the study * If biologically male, either sterile or using acceptable form of birth control * Be willing and able to complete study procedures	* Has previously undergone unilateral simple bunionectomy. * Has a planned concurrent surgical procedure * Has a concurrent painful condition that may require analgesic treatment during the study period or may confound postsurgical pain assessments * Has a history or clinical manifestation of significant medical, neuropsychiatric, or other condition that could preclude or impair study participation or interfere with study assessments. * Has a history of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency. * Has history or evidence of impaired liver function (e.g., alanine aminotransferase \[ALT\] \> 3 × upper limit of normal \[ULN\] or total bilirubin \> 2 × ULN), active hepatic disease, or cirrhosis. * Has history or evidence of impaired renal function (e.g., creatinine \> 1.5 × ULN). * Has a history of malignancy in the past year * Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months

Inclusion Criteria

Exclusion Criteria

* Ability to sign ICF
* Bunion for elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries
* BMI ≤ 39 kg/m2
* If biologically female, not pregnant or planning to become pregnant over the study
* If biologically male, either sterile or using acceptable form of birth control
* Be willing and able to complete study procedures

* Has previously undergone unilateral simple bunionectomy.
* Has a planned concurrent surgical procedure
* Has a concurrent painful condition that may require analgesic treatment during the study period or may confound postsurgical pain assessments
* Has a history or clinical manifestation of significant medical, neuropsychiatric, or other condition that could preclude or impair study participation or interfere with study assessments.
* Has a history of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency.
* Has history or evidence of impaired liver function (e.g., alanine aminotransferase \[ALT\] \> 3 × upper limit of normal \[ULN\] or total bilirubin \> 2 × ULN), active hepatic disease, or cirrhosis.
* Has history or evidence of impaired renal function (e.g., creatinine \> 1.5 × ULN).
* Has a history of malignancy in the past year
* Has 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 Date2023-05-22

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-05-22

Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

Bunion