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