Clinical Trials Logo

Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04860635
Other study ID # 100-CIP03-P
Secondary ID
Status Suspended
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05534230 - Dexmedetomidine for Pain Reduction in CABG N/A
Recruiting NCT06275698 - HONEY for the Treatment of POst-Tonsillectomy Pain N/A
Recruiting NCT04436224 - Hydromorphone for ICU-analgesia in Patients With Non-mechanical Ventilation Phase 4
Not yet recruiting NCT04548323 - Hypoalgesic Effects of Walking and Running Imagined
Completed NCT06054945 - Clinical Impact of IPACK Block Addition to Suprainguinal Fascia Iliaca Block
Completed NCT04394481 - Extension of Analgesia by Combined Injection of Dexamethasone and Dexmedetomidine After Arthroscopic Shoulder Surgery Phase 4
Completed NCT04690647 - The Efficacy of Suprainguinal Fascia Iliaca Compartment Block for Analgesia After Elective Total Hip Replacement. N/A
Completed NCT05034601 - ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure N/A
Completed NCT03740815 - Feasibility of Serratus Plane Block Associated With Sedation in Axillary Dissection N/A
Recruiting NCT05454202 - Assessment of the Interest of ANI in the Non-communicating Patient in Palliative Care
Recruiting NCT04554186 - Serratus Anterior Plane Block Versus Thoracic Paravertebral Block. N/A
Not yet recruiting NCT06393777 - Effectiveness of Pre-administered Natural Sweet-tasting Solution (Honey) for Decreasing Pain of Needle Insertion N/A
Not yet recruiting NCT04519463 - The Effect of Local Anesthesia With Lidocaine During Insertion and Removal of Nasal Packing Early Phase 1
Completed NCT02916342 - Interscalene Block Versus Combined Supraprascapular: Axillary Nerve Blocks Phase 4
Not yet recruiting NCT02549118 - Tenoxicam for Intrapartum Analgesia Phase 2
Completed NCT03206554 - Local Infiltration Analgesia in Total Knee Arthroplasty Phase 2
Not yet recruiting NCT02190760 - Comparison Between Perineural and Systemic Effect of Dexamethasone for Interscalene Brachial Plexus Block. N/A
Completed NCT01789606 - Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet Phase 3
Completed NCT01299584 - ULTIVA Post Marketing Surveillance N/A
Completed NCT00137085 - Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation N/A