CPL-01 in the Management of Postoperative Pain After Bunionectomy

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.

Conditions

Bunion

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Study Overview

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Study Details

Study overview

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.

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

CPL-01 in the Management of Postoperative Pain After Bunionectomy

Condition
Bunion
Intervention / Treatment

-

Contacts and Locations

Salt Lake City

Todd Bertoch, Salt Lake City, Utah, United States, 84101

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cali Pharmaceuticals LLC,

Erol Onel, STUDY_DIRECTOR, Cali Biosciences

Study Record Dates

2024-12-31