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

Completed · Phase 3

Conditions studied: Post Operative Pain

In brief

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.

Key facts

Study ID

NCT05603832

Run by

Arthritis Innovation Corporation

People needed

151

Starts

2022-11-17

Expected to finish

2024-08-23

Last updated by the study team

2025-12-18

Who can join

Age: 45 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Females of childbearing potential with a negative serum pregnancy test at screening, or males that have a partner who is a woman of child-bearing potential (WOCBP), who agree to employ adequate birth control measures for the full duration of the study.

You may not qualify if…

• 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
• Prior or current presence of hardware in index knee other than screws from previous ligament repair that do not require manipulation or removal for TKR surgery
• Other planned major surgery within 12 months of study surgery
• Concurrent painful physical condition that is unrelated to the study knee (e.g., back, shoulder or contralateral knee pain) that will require analgesic treatment, such as NSAIDs or opioids, during study follow-up
• Current NRS pain intensity in the contralateral knee with a severity ≥ 4
• Current or historical evidence of any clinically significant disease or condition, especially cardiovascular, pulmonary or neurological, that, in the opinion of the Investigator, may increase the risk of surgery or complicate or affect the subject's study follow-up
• Suspected opioid abuse in the last 12 months with a score exceeding 5 on the DAST-10 questionnaire, and/or taking opioids ≥ 46 of the previous 90 days, and currently taking >90 mg in morphine milligram equivalents (MME) at least 5 days per week in the month prior to screening.
• History of alcohol abuse within previous 12 months (score of 4 on CAGE questionnaire)
• Anxiety Sensitivity Index (ASI) score >40
• Fear of Pain Score (FPQ-III) score >120
• Uncontrolled depression, mood or anxiety disorder (score exceeding 14 on PHQ-9 questionnaire)
• Participation or scheduled participation in another clinical study involving an investigational drug or device within one calendar month before screening or during study follow-up
• Current medical diagnosis or patient-reported seizure disorder
• Current peripheral neuropathy
• History of complex regional pain syndrome (CRPS)
• Diagnosis of clinically significant liver and/or renal abnormalities within previous 2 years

Where it is running

• 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

Full record on ClinicalTrials.gov

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