Status:

COMPLETED

CPL-01 in the Management of Postoperative Pain After Bunionectomy

Lead Sponsor:

Cali Pharmaceuticals LLC

Conditions:

Bunion

Eligibility:

All Genders

18-75 years

Phase:

PHASE3

Brief Summary

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 ...

Detailed Description

After signing informed consent, subjects will be randomly assigned to receive study drug (either Investigational product, positive control, or negative control) during unilateral distal bunionectomy w...

Eligibility Criteria

Inclusion 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

Exclusion Criteria:

  • 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

Key Trial Info

Start Date :

May 22 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 6 2025

Estimated Enrollment :

616 Patients enrolled

Trial Details

Trial ID

NCT05831449

Start Date

May 22 2023

End Date

October 6 2025

Last Update

March 18 2026

Active Locations (1)

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1

Todd Bertoch

Salt Lake City, Utah, United States, 84101