CPL-01 in the Management of Postoperative Pain After Bunionectomy

Cali Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Bunion

Treatments: Drug: Placebo; Drug: Local anesthetic injection of CPL-01; Drug: Naropin, 0.5% Injectable Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT05831449

CPL-01-302

Details and patient eligibility

About

Subjects receive study drug during bunionectomy and are followed for pain and opioid use, with the hypothesis that those who receive CPL-01 will have less pain and less opioid use than either control arm.

Full description

After signing informed consent, subjects will be randomly assigned to receive study drug (either Investigational product, positive control, or negative control) during unilateral distal bunionectomy with osteotomy. Subjects will then remain at the hospital for 72-hours where pain and rescue medication usage will be assessed. Follow-up will then occur at 7 and 30 days afterwards.

The hypothesis is that subjects who receive CPL-01 will have less pain and require fewer opioids than subjects in the other two arms.

Enrollment: 574 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ability to sign ICF
• Bunion for elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries
• BMI ≤ 39 kg/m2
• If biologically female, not pregnant or planning to become pregnant over the study
• If biologically male, either sterile or using acceptable form of birth control
• Be willing and able to complete study procedures

Exclusion criteria

• Has previously undergone unilateral simple bunionectomy.
• Has a planned concurrent surgical procedure
• Has a concurrent painful condition that may require analgesic treatment during the study period or may confound postsurgical pain assessments
• Has a history or clinical manifestation of significant medical, neuropsychiatric, or other condition that could preclude or impair study participation or interfere with study assessments.
• Has a history of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency.
• Has history or evidence of impaired liver function (e.g., alanine aminotransferase [ALT] > 3 × upper limit of normal [ULN] or total bilirubin > 2 × ULN), active hepatic disease, or cirrhosis.
• Has history or evidence of impaired renal function (e.g., creatinine > 1.5 × ULN).
• Has a history of malignancy in the past year
• Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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574 participants in 3 patient groups, including a placebo group

CPL-01

Experimental group

Description:

Local infiltration of study drug

Treatment:

Drug: Local anesthetic injection of CPL-01

Ropivacaine HCl

Active Comparator group

Description:

Local infiltration of study drug

Treatment:

Drug: Naropin, 0.5% Injectable Solution

Placebo

Placebo Comparator group

Description:

Local infiltration of study drug

Treatment:

Drug: Placebo