Clinical trial NCT05411861: Post-Operative Pain and Opioid Reduction Trial After Bunionectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hallux Valgus and Bunion
Lead sponsor: Cali Pharmaceuticals LLC
Sponsor class: INDUSTRY
First posted: 2022-06-09
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Bunion Surgery
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: AUC72
timeFrame: 72 hours post-operative
Secondary outcomes:
measure: Opioid use (MME)
timeFrame: 72 hours post-operative
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Bakersfield
country: United States
facility: Trovare Clinical Research
state: California
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Cali Biosciences
name: Erol Onel
role: STUDY_CHAIR
References: