Safety of F14 Following Total Knee Replacement

Analgesia Clinical Trial

Official title:

An Open Label Safety Study of a Single Administration of F14 in Patients Undergoing Unilateral Total Knee Replacement

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04860635
• Other study ID #: 100-CIP03-P
• Status: Suspended
• Phase: Phase 2/Phase 3
• Start date: September 2024
• Est. completion date: September 2025

Study information

• Verified date: February 2023
• Source: Arthritis Innovation Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male and/or females indicated for primary, unilateral TKR

2. Between 45-80 years of age

3. Capable of giving signed informed consent

4. Body Mass Index (BMI) = 40 kg/m2

5. 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

6. Absence of fixed flexion deformity exceeding 15deg

7. Absence of varus or valgus deformity exceeding 15deg

8. Minimum pre-operative flexion arc of 100deg

9. American Society of Anesthesiologists Physical Status Classification System (ASA-PSC) score = 3

10. 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

11. Has undergone successful total knee replacement surgery, which in the opinion of the Investigator, will not affect the subject's study follow-up

Exclusion Criteria:

1. 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

2. 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

3. Total or partial knee arthroplasty in the contralateral knee < 6 months prior to study surgery

4. Participation or scheduled participation in another clinical study involving an investigational drug or device within 30 days before screening or during study follow-up

5. Active or past infection in the index knee

6. Documented osteonecrosis of the index knee within previous 12 months

7. Other planned major surgery within 12 months of study surgery

8. 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

9. Diagnosis of skin disorders including psoriasis, vascular insufficiency ulcers, and chronic venous stasis

10. History of coronary or vascular stent placed within 3 months

11. 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

12. Current medical diagnosis or subject-reported seizure disorder

13. Current peripheral neuropathy

14. History of complex regional pain syndrome (CRPS)

15. Diagnosis of clinically significant liver hepatic and/or renal abnormalities within previous 2 years

16. Diagnosis of diabetes with HbA1c =7%

17. 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

18. Treatment with immunosuppressants, antipsychotics, anticholinergics, or anticonvulsants within 1 month of intervention (antipsychotic stable dosage established for >30 days will be allowed)

19. Current or historical evidence of any clinically significant disease or condition, especially cardiovascular, pulmonary, or neurological

20. Participation in active or pending personal injury or workers' compensation litigation

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• F14 (sustained release celecoxib)
Celecoxib in BEPO® drug delivery system

Locations

Country	Name	City	State
United States	Panorama Orthopedics & Spine Center	Denver	Colorado
United States	Endeavor Clinical Trials	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Arthritis Innovation Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	NRS pain intensity	Numerical rating scale (NRS); 11-point scale ranges from '0' representing "no pain" to '10' representing "worst imaginable pain"	From Day 1 to 3 months
Other	Duration of need for walking aids		From Day 1 to 3 months
Other	Proportion of subjects using concomitant analgesics at any timepoint		From Day 1 to 3 months
Other	Celecoxib concentration in plasma	PK sub-study in 15 participants	At specified timepoints up to 3 months
Primary	Incidence and severity of treatment-emergent adverse events (TEAEs)		From Day 0 to 12 months