Phase 2b Randomized, Double-Blind, Placebo- and Active-Controlled Bunionectomy Trial

• Status: Not yet recruiting
• Trial end date: 2023-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cali Pharmaceuticals LLC
• Treatments: Analgesics; Analgesics, Non-Narcotic

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