Status:
COMPLETED
Post-Operative Pain and Opioid Reduction Trial After Bunionectomy
Lead Sponsor:
Cali Pharmaceuticals LLC
Conditions:
Hallux Valgus and Bunion
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This is a Phase 2b, randomized, double blind, placebo and active controlled study with an Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing bunionectomy.
Detailed Description
Near the completion of surgery, a single dose of study drug (CPL-01, saline placebo, or ropivacaine HCl) will be infiltrated. Subjects will remain in the hospital/research facility for a minimum of 72...
Eligibility Criteria
Inclusion
- Be willing and able to sign the informed consent form (ICF) prior to study participation
- In the medical judgment of the Investigator, be a reasonably healthy adult 18 - 75 years of age, inclusive, and ASA Class I or II at the time of randomization
- Plan to undergo an elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries
- Have a BMI ≤ 39 kg/m2
Exclusion
- Previous unilateral simple bunionectomy
- Has a planned concurrent surgical procedure that may impact pain scores, rescue medication use, or ability to fulfill the requirements of the protocol
- Concurrent painful condition
- Active skin disease or other clinically significant abnormality at the anticipated surgical site that could interfere with the planned surgery
- Known hypersensitivity or known allergy, as determined by the Investigator, to the ingredients (i.e., excipients) of the study drug or any peri- or postoperative medications used in this study
- History or clinical manifestation of significant medical, neuropsychiatric, or other condition that could preclude or impair study participation or interfere with study assessments
- History of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency
- History or evidence of impaired liver function (e.g., ALT \> 3 × upper limit of normal \[ULN\] or total bilirubin \> 2 × ULN), active hepatic disease, or cirrhosis
- History or evidence of impaired renal function (e.g., creatinine \> 1.5 × ULN)
- History of malignancy in the past year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized in situ carcinoma of the cervix
- Has or has had active COVID-19 infection within 3 months prior to surgery
Key Trial Info
Start Date :
June 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2022
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT05411861
Start Date
June 14 2022
End Date
November 7 2022
Last Update
January 11 2023
Active Locations (3)
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1
Arizona Research Center
Phoenix, Arizona, United States, 85053
2
Trovare Clinical Research
Bakersfield, California, United States, 93301
3
Jean Brown Research
Salt Lake City, Utah, United States, 84107