NCT04860635暂停2 期
An Open Label Safety Study of a Single Administration of F14 in Patients Undergoing Unilateral Total Knee Replacement
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Incidence and severity of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
Open-label single-arm study in which all subjects receive F14 as part of a scheduled TKR and multimodal analgesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
- •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
研究组 & 干预措施
F14 (sustained release celecoxib)
Experimental
Intra-articular F14 administration immediately following TKR surgery, and concurrent with multimodal standard of care analgesia
干预措施: F14 (sustained release celecoxib) (Drug)
结局指标
主要结局
Incidence and severity of treatment-emergent adverse events (TEAEs)
时间窗: From Day 0 to 12 months
次要结局
未报告次要终点
研究者
研究点 (4)
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