A Phase 3, Multicenter, Randomized, Double-Blind, Parallel Group Study of the Efficacy and Safety of a Single Administration of F14 for Postoperative Analgesia in Patients Undergoing Unilateral Total Knee Replacement

Arthritis Innovation Corporation7 sites in 1 country151 target enrollmentNovember 17, 2022

ConditionsPost Operative Pain

InterventionsF14 0.25 % Bupivacaine HCl Acetaminophen Methocarbamol

DrugsF14 0.25 % Bupivacaine HCl Acetaminophen Methocarbamol

Overview

Phase: Phase 3
Intervention: F14
Conditions: Post Operative Pain
Sponsor: Arthritis Innovation Corporation
Enrollment: 151
Locations: 7
Primary Endpoint: Time-weighted Area Under the Curve (AUC) of numeric rating scale (NRS) pain scores
Status: Completed
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase 3, randomized, double blind, multicenter study to evaluate the analgesic efficacy and safety of a single intra-articular dose of F14 (625 mg sustained release celecoxib) administered concurrent with multimodal analgesia in patients undergoing total knee replacement surgery, compared to multimodal analgesia alone.

Registry

clinicaltrials.gov

Start Date

November 17, 2022

End Date

August 23, 2024

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Arthritis Innovation Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and/or females indicated for primary, unilateral total knee replacement (TKR)
•Between 45-80 years of age inclusive at the time of signing the informed consent
•Capable of giving signed informed consent and complying with requirements and restrictions listed in the informed consent form (ICF) and in this protocol
•Body Mass Index (BMI) ≤ 40 kg/m2
•Medically stable as determined by the Investigator, based on physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG) findings, as well as medical history from patient and pre-study source documents from other care providers
•Absence of moderate to severe fixed flexion deformity
•Absence of moderate to severe varus or valgus deformity
•Minimum pre-operative flexion arc of 100 degrees
•Absence of steroid, hyaluronic acid, platelet rich plasma, or any other type of therapeutic injection(s) in the index knee within 3 months before scheduled surgery
•American Society of Anesthesiologists Physical Status Classification System (ASA-PSC) score ≤ 3

Exclusion Criteria

•Known allergy or hypersensitivity to active ingredient celecoxib, OR known allergy or hypersensitivity to sulfonamide antibiotics or sulfa containing drugs when an allergy to celecoxib is unknown
•Unwilling or unable to discontinue use of nonsteroidal anti-inflammatory drugs (NSAIDs) at least 7 days before study surgery and for 6 weeks following study surgery
•Unwilling or unable to discontinue use of medical or recreational marijuana or cannabidiol (CBD) at least 10 days before study surgery and for 3 months following study surgery
•Unwilling or unable to discontinue use of pregabalin, gabapentin or other drugs for neuropathic pain at least 7 days prior to study surgery and for 3 months following study surgery
•Unwilling or unable to discontinue opioid analgesics at least 7 days prior to surgery
•Has an allergy or contraindication to opioids or NSAIDs or acetaminophen
•Active or past infection in the index knee
•Total or partial knee arthroplasty in the contralateral knee \< 6 months prior to study surgery
•Knee surgery (including cruciate ligament, cartilage or osteotomy) other than simple arthroscopy in either knee in the last 12 months (excluding contralateral total or partial knee replacement)
•Documented osteonecrosis within previous 12 months