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COMPLETEDPHASE3

A Phase 3 Study of F14 for Management of Pain Following Total Knee Replacement

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

NCT05603832•Arthritis Innovation Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

45 - 80 years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

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
+25 more criteria

Locations (7)

Woodland International Research Group

Little Rock, Arkansas, United States

Phoenix Clinical Research

Tamarac, Florida, United States

The Orthopedic Center

Tulsa, Oklahoma, United States

HD Research - First Surgical Hospital

Bellaire, Texas, United States

HD Research - Legent Orthopedic Hospital

Carrollton, Texas, United States

Endeavor Clinical Trials

San Antonio, Texas, United States

CenExel JBR

Salt Lake City, Utah, United States

Key Dates

Start Date

November 17, 2022

Primary Completion Date

November 22, 2023

Completion Date

August 23, 2024

Last Updated

December 18, 2025

Enrollment

151

ACTUAL participants

Conditions

Post Operative Pain

Interventions

F14

DRUG

0.25 % Bupivacaine HCl

DRUG

Acetaminophen

DRUG

Methocarbamol

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase 3 Study of F14 for Management of Pain Following Total Knee Replacement

Inclusion Criteria

Exclusion Criteria

Comparison Between Tranversus Abdominis Plane (TAP) Block With Only Bupivacaine and TAP Block With Bupivacaine Plus Ketamine in Reducing Postoperative Pain After Total Abdominal Hystrectomy

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Comparison Between Two Instrumentation Techniques on Postoperative Pain and Level of Neuropeptides