Randomized, Double-Blind, Placebo- and Active-Controlled, Dose Escalation and Optional Dose Expansion Study to Evaluate Safety, Efficacy, and PK of CPL-01 in Post-Op Pain After Unilateral Distal First Metatarsal Bunionectomy + Osteotomy
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Cali Pharmaceuticals LLC
- Enrollment
- 73
- Locations
- 3
- Primary Endpoint
- AUC72
Study Overview
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 hours after the start of study drug administration to undergo postoperative assessments. Subjects will return to the study site on Day 7 to complete follow up assessments, on Day 28 for follow-up assessments including an X-Ray, and on Day 42 for the end-of-study (EOS) visit.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Separate blinded and unblinded study teams
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
CPL-01
Low dose of CPL-01
Intervention: Analgesic Non Narcotic (Drug)
Ropivacaine HCl
Low dose of Ropivacaine HCl
Intervention: Analgesic Non Narcotic (Drug)
Placebo
Low volume of placebo
Intervention: Analgesic Non Narcotic (Drug)
Outcomes
Primary Outcomes
AUC72
Time Frame: 72 hours post-operative
Pain score through 72 hours post-operative
Secondary Outcomes
- Opioid use (MME)(72 hours post-operative)