AnalgesiaPhase 2/3NCT04860635
Safety of F14 Following Total Knee Replacement
A Phase 2/3 study testing F14 (sustained release celecoxib) in people with Analgesia, run by Arthritis Innovation Corporation at 2 sites in United States.
Trial summary
Open-label single-arm study in which all subjects receive F14 as part of a scheduled TKR and multimodal analgesia Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Analgesia
- What is being tested?
- F14 (sustained release celecoxib)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2027to Jul 2028
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Absence of varus or valgus deformity exceeding 15deg
- Minimum pre-operative flexion arc of 100deg
- 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 with a partner that is of childbearing potential, who agree to employ adequate birth control measures for the full duration of the study
- Has undergone successful total knee replacement surgery, which in the opinion of the Investigator, will not affect the subject's study follow-up
Who cannot join
- 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
- Total or partial knee arthroplasty in the contralateral knee < 6 months prior to study surgery
- Participation or scheduled participation in another clinical study involving an investigational drug or device within 30 days before screening or during study follow-up
- Active or past infection in the index knee
- Documented osteonecrosis of the index knee within previous 12 months
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- Other planned major surgery within 12 months of study surgery
- Had a malignancy in the last year, except for non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix
- Diagnosis of skin disorders including psoriasis, vascular insufficiency ulcers, and chronic venous stasis
- History of coronary or vascular stent placed within 3 months
- Suspected opioid abuse in the last 12 months with a score exceeding 5 on the DAST-10 questionnaire, and/or taking opioids on most days in the past three months, and currently taking >120 mg morphine equivalent dose (MED) at least 5 days per week in the month prior to screening
- Current medical diagnosis or subject-reported seizure disorder
- Current peripheral neuropathy
- History of complex regional pain syndrome (CRPS)
- Diagnosis of clinically significant liver hepatic and/or renal abnormalities within previous 2 years
- Diagnosis of diabetes with HbA1c ≥7%
- Current inflammatory arthritides (e.g., rheumatoid arthritis, lupus erythematosus, ankylosing spondylitis, psoriatic arthritis), or traumatic bone injuries within 12 months before scheduled surgery, except for clinically stable/non-active gout that does not affect the knee and does not interfere with walking
- Treatment with immunosuppressants, antipsychotics, anticholinergics, or anticonvulsants within 1 month of intervention (antipsychotic stable dosage established for >30 days will be allowed)
- Current or historical evidence of any clinically significant disease or condition, especially cardiovascular, pulmonary, or neurological
- Participation in active or pending personal injury or workers' compensation litigation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Panorama Orthopedics & Spine Center
Denver, Colorado, 80401
Endeavor Clinical Trials
San Antonio, Texas, 78229
About this study
Official title: An Open Label Safety Study of a Single Administration of F14 in Patients Undergoing Unilateral Total Knee Replacement
Open-label single-arm study in which all subjects receive F14 as part of a scheduled TKR and multimodal analgesia
- Conditions
- Analgesia
- Being tested
- F14 (sustained release celecoxib)
- Keywords
- total knee arthroplasty, postoperative pain, NSAID, multimodal analgesia
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F14 (sustained release celecoxib)Drug
Celecoxib in BEPO® drug delivery system
| Study group | Role | What they receive |
|---|---|---|
| F14 (sustained release celecoxib) | Experimental | Intra-articular F14 administration immediately following TKR surgery, and concurrent with multimodal standard of care analgesia Receives: Drug: F14 (sustained release celecoxib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs)
Measured: From Day 0 to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study startJan 2027 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Why it stopped: Study superseded by alternative Phase 3 trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arthritis Innovation Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jared Foran, MD, Principal investigator, Panorama Orthopedics & Spine Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860635
- Sponsor's protocol ID
- 100-CIP03-P
- Status last verified
- Jun 2026
- First submitted
- 20 Apr 2021
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Safety Study of a Single Administration of F14 in Patients Undergoing Unilateral Total Knee Replacement
- ClinicalTrials.gov ID
- NCT04860635
- Acronym / sponsor ID
- 100-CIP03-P
- Conditions
- Analgesia
- Keywords
- total knee arthroplasty, postoperative pain, NSAID, multimodal analgesia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study superseded by alternative Phase 3 trial
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Arthritis Innovation CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label single-arm study in which all subjects receive F14 as part of a scheduled TKR and multimodal analgesia
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label
| Arm | Type | Receives |
|---|---|---|
| F14 (sustained release celecoxib) | Experimental | Drug: F14 (sustained release celecoxib)Intra-articular F14 administration immediately following TKR surgery, and concurrent with multimodal standard of care analgesia |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (20 listed)
- 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
- Total or partial knee arthroplasty in the contralateral knee < 6 months prior to study surgery
- Participation or scheduled participation in another clinical study involving an investigational drug or device within 30 days before screening or during study follow-up
- Active or past infection in the index knee
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F14 (sustained release celecoxib)Celecoxib in BEPO® drug delivery system | Drug | F14 (sustained release celecoxib) |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: From Day 0 to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jared Foran, MD principal investigator
Panorama Orthopedics & Spine Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing F14 (sustained release celecoxib) in people with Analgesia, run by Arthritis Innovation Corporation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (TEAEs) (time frame: From Day 0 to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.