SuspendedPhase 2/3

Safety of F14 Following Total Knee Replacement

Stopped: Study superseded by alternative Phase 3 trial

United States100 participantsStarted 2027-01

Plain-language summary

Open-label single-arm study in which all subjects receive F14 as part of a scheduled TKR and multimodal analgesia

Who can participate

Age range

45 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Male and/or females indicated for primary, unilateral TKR
. Between 45-80 years of age
. Capable of giving signed informed consent
. Body Mass Index (BMI) ≤ 40 kg/m2
. Medically stable as determined by the Investigator, based on physical examination, clinical laboratory tests, and 12-lead ECG findings, as well as medical history from subject and pre-study source documents from other care providers
. Absence of fixed flexion deformity exceeding 15deg
. Absence of varus or valgus deformity exceeding 15deg
. Minimum pre-operative flexion arc of 100deg

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) within 7 days of scheduled surgery, or medical marijuana or cannabidiol (CBD) within 10 days

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence and severity of treatment-emergent adverse events (TEAEs)

Timeframe: From Day 0 to 12 months

Trial details

NCT IDNCT04860635

SponsorArthritis Innovation Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-07

View on ClinicalTrials.gov More Analgesia trials