Post-Operative Pain and Opioid Reduction Trial After Bunionectomy (MERIT-2)

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

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.

Study Overview

• Status: Completed
• Conditions: Hallux Valgus and Bunion
• Intervention / Treatment: Drug: Analgesic Non Narcotic

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 Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Arizona Research Center
  • California
    • Bakersfield, California, United States, 93301
      • Trovare Clinical Research
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Jean Brown Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CPL-01; Low dose of CPL-01	Drug: Analgesic Non Narcotic; Injection of protocol-specified volume of local analgesic; Other Names: Infiltration of local analgesic
Active Comparator: Ropivacaine HCl; Low dose of Ropivacaine HCl	Drug: Analgesic Non Narcotic; Injection of protocol-specified volume of local analgesic; Other Names: Infiltration of local analgesic
Placebo Comparator: Placebo; Low volume of placebo	Drug: Analgesic Non Narcotic; Injection of protocol-specified volume of local analgesic; Other Names: Infiltration of local analgesic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC72	Pain score through 72 hours post-operative	72 hours post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid use (MME)	Opioid use through 72 hours post-operative	72 hours post-operative

Collaborators and Investigators

• Sponsor: Cali Pharmaceuticals LLC
• Investigators: Study Chair: Erol Onel, Cali Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2022
• Primary Completion (Actual): September 26, 2022
• Study Completion (Actual): November 7, 2022

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Foot Deformities; Hallux Valgus; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics; Analgesics, Non-Narcotic
• Other Study ID Numbers: CPL-01-202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No