Post-Operative Pain and Opioid Reduction Trial After Bunionectomy

Completed · Phase 2 · Has a placebo group

Conditions studied: Hallux Valgus and Bunion

In brief

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.

Key facts

Study ID

NCT05411861

Run by

Cali Pharmaceuticals LLC

People needed

73

Starts

2022-06-14

Expected to finish

2022-11-07

Last updated by the study team

2023-01-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arizona Research Center — Phoenix, Arizona, United States
• Trovare Clinical Research — Bakersfield, California, United States
• Jean Brown Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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