Post Operative PainPhase 3NCT05603832
A Phase 3 Study of F14 for Management of Pain Following Total Knee Replacement
A Phase 3 study testing F14, 0.25 % Bupivacaine HCl and Acetaminophen in people with Post Operative Pain, run by Arthritis Innovation Corporation at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- F14, 0.25 % Bupivacaine HCl and Acetaminophen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 7 sitesUnited States
- Study dates
- 17 Nov 2022to 23 Aug 2024
- Phase
- Phase 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 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
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- 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.
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) 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
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- 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
- 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 within one calendar month of intervention. Also, antipsychotics, anticholinergics, or anticonvulsants within one calendar month of intervention unless stable dosage established for > one calendar month and does not plan to change during 3 month follow up
- Diagnosis of skin disorders including psoriasis, vascular insufficiency ulcers, and chronic venous stasis
- Subjects with sleep apnea associated with a history of postoperative delirium. If symptomatic sleep apnea is currently treated with continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BIPAP), use must be continued post-operatively
- History of coronary or vascular stent placed within 3 months
- Had a malignancy in the last 12 months, except for non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix
- Positive urine drug screen for disallowed medication pre-operatively on day of study surgery
- Participation in active or pending personal injury or workers' compensation litigation related to index knee
- Any reason based on investigator clinical judgment, that subject may be non-compliant with respect to study obligations or assessments
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
HD Research - First Surgical Hospital
Bellaire, Texas, 77401
HD Research - Legent Orthopedic Hospital
Carrollton, Texas, 75006
Woodland International Research Group
Little Rock, Arkansas, 72211
CenExel JBR
Salt Lake City, Utah, 84107
Endeavor Clinical Trials
San Antonio, Texas, 78240
Phoenix Clinical Research
Tamarac, Florida, 33321
The Orthopedic Center
Tulsa, Oklahoma, 74104
About this study
Official title: 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
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.
- Conditions
- Post Operative Pain
- Being tested
- F14, 0.25 % Bupivacaine HCl, Acetaminophen, Methocarbamol
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F14Drug
625 mg intra-articular sustained-release celecoxib
0.25 % Bupivacaine HClDrug
Local anesthetic
AcetaminophenDrug
Analgesic
MethocarbamolDrug
Muscle relaxant
| Study group | Role | What they receive |
|---|---|---|
| F14 + Multimodal Analgesia | Experimental | Not described Receives: Drug: F14; Drug: 0.25 % Bupivacaine HCl; Drug: Acetaminophen; Drug: Methocarbamol |
| Multimodal Analgesia | Active comparator | Not described Receives: Drug: 0.25 % Bupivacaine HCl; Drug: Acetaminophen; Drug: Methocarbamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted Area Under the Curve (AUC) of numeric rating scale (NRS) pain scores
Measured: 2 weeks
Secondary outcomes (5)
Index knee range of motion (ROM) at 6 weeks
Measured: 6 weeks
Time-weighted AUC of NRS pain scores
Measured: 7 Days
Time-weighted AUC of NRS pain scores
Measured: 6 weeks
Proportion of subjects using opioid rescue medication at 2 weeks
Measured: 2 weeks
Time-weighted AUC of NRS pain scores
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start17 Nov 2022
- Primary completion22 Nov 2023
- Study completion23 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arthritis Innovation Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Allucent
- Responsible party
- Sponsor
- Investigators
- Matthew Shive, PhD, Study director, Arthritis Innovation Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603832
- Sponsor's protocol ID
- 100-CIP02-P
- Status last verified
- Dec 2025
- First submitted
- 28 Oct 2022
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05603832
- Acronym / sponsor ID
- 100-CIP02-P
- Conditions
- Post Operative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Arthritis Innovation CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Allucent
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 22 Nov 2023 (actual)
- Study completion
- 23 Aug 2024 (actual)
- First posted
- 3 Nov 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F14 + Multimodal Analgesia | Experimental | Drug: F14, Drug: 0.25 % Bupivacaine HCl, Drug: Acetaminophen, Drug: Methocarbamol |
| Multimodal Analgesia | Active comparator | Drug: 0.25 % Bupivacaine HCl, Drug: Acetaminophen, Drug: Methocarbamol |
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 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
Key exclusion criteria (35 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) 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
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 |
|---|---|---|
| F14625 mg intra-articular sustained-release celecoxib | Drug | F14 + Multimodal Analgesia |
| 0.25 % Bupivacaine HClLocal anesthetic | Drug | F14 + Multimodal Analgesia, Multimodal Analgesia |
| AcetaminophenAnalgesic | Drug | F14 + Multimodal Analgesia, Multimodal Analgesia |
| MethocarbamolMuscle relaxant | Drug | F14 + Multimodal Analgesia, Multimodal Analgesia |
Primary outcome
Time-weighted Area Under the Curve (AUC) of numeric rating scale (NRS) pain scores
Time frame: 2 weeks
5 secondary outcomes
Index knee range of motion (ROM) at 6 weeks
Time frame: 6 weeks
Time-weighted AUC of NRS pain scores
Time frame: 7 Days
Time-weighted AUC of NRS pain scores
Time frame: 6 weeks
Proportion of subjects using opioid rescue medication at 2 weeks
Time frame: 2 weeks
Time-weighted AUC of NRS pain scores
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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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.
Matthew Shive, PhD study director
Arthritis Innovation Corporation
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing F14, 0.25 % Bupivacaine HCl and Acetaminophen in people with Post Operative Pain, run by Arthritis Innovation Corporation at 7 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 35 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: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time-weighted Area Under the Curve (AUC) of numeric rating scale (NRS) pain scores (time frame: 2 weeks). 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 18 Dec 2025.