EUCTR2014-005329-11-EE进行中（未招募）不适用
A Double-Blind, Randomized, Single-Dose Study to Assess the Safety and Efficacy of FX006 for the Treatment of Pain in Patients with Osteoarthritis of the Knee
Flexion Therapeutics0 个研究点目标入组 450 人开始时间: 2015年1月13日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written consent to participate in the study
- •2. Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
- •3. Male or female =40 years of age
- •4. Symptoms associated with OA of the knee for = 6 months prior to Screening (patient reported is acceptable)
- •5. Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA (Altman et al, 1986) as follows:
- •Knee pain
- •at least 1 of the following:
- •o Age > 50 years
- •o Stiffness < 30 minutes
- •Osteophytes
- •6. Kellgren-Lawrence (K-L) Grade 2 or 3 in the index knee based on X-ray performed during Screening (locally read)
- •Grade 2: definite osteophytes and possible narrowing of joint space
- •Grade 3: moderate multiple osteophytes, definite narrowing of joint space and some sclerosis and possible deformity of bone ends
- •7. Index knee pain for >15 days over the last month (as reported by the patient)
- •8. Mean score of = 5 and = 9 on the 24-hr average pain score (0-10 numeric ratings scale (NRS)) using the average daily ratings for at least 5 of the 7 days prior to Day 1
- •9. No more than one 24-hr average pain score (0-10 NRS) reported as 10” during the 7 days prior to Day 1
- •10. If bilateral OA exists, pain in the contralateral knee must be less than pain in the index knee as reported by the patient
- •11. Body mass index (BMI) = 40 kg/m2
- •12. Ambulatory and in good general health
- •13. Willingness to abstain from use of protocol-specified restricted medications and non-pharmacological therapies during the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •Patients fulfilling at least one of the following criteria may not be included in the study:
- •Disease-related criteria
- •1. Any condition that could possibly confound the patient’s assessment of index knee pain in judgment of the investigator (i.e., ipsilateral hip OA, gout, radicular low back pain and hip pain that is referred to the knee that could cause misclassification, pain in any other area of the lower extremities or back that is equal to or greater than the index knee pain)
- •2. Fibromyalgia, Reiter’s syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or arthritis associated with inflammatory bowel disease
- •3. History of infection in the index knee
- •4. Clinical signs and symptoms of active knee infection or crystal disease of the index knee within 1 month of Screening
- •5. Unstable joint (such as a torn anterior cruciate ligament) within 12 months of Screening Previous or concomitant OA treatment-related criteria
- •6. IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
- •7. IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
- •8. Intramuscular (IM) or oral corticosteroids (investigational or marketed) within 1 month of Screening
- •9. Any other IA investigational drug/biologic use within 6 months of Screening
- •10. Prior use of FX006
- •11. Prior arthroscopic or open surgery of the index knee within 12 months of Screening
- •12. Planned/anticipated surgery of the index knee or any other surgery that would require use of a restricted
- •medication during the study period Patient-related criteria
- •13. Known hypersensitivity to any form of triamcinolone
- •14. History of sarcoidosis or amyloidosis
- •15. Active or history of malignancy within the last 5 years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or effectively managed cervical carcinoma
- •16. Known active or quiescent systemic fungal, bacterial (including tuberculosis), viral or parasitic infections, or ocular herpes simplex
- •17. Any infection requiring intravenous antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening
- •18. History of osteomyelitis
- •19. Known or clinically suspected infection with human immunodeficiency virus (HIV), hepatitis B or C viruses
- •20. Any clinically significant electrocardiogram (ECG) abnormality as judged by the Investigator
- •21. Patients requiring or likely to require chronic treatment with corticosteroids during the study period based on patient medical history
- •22. Uncontrolled diabetes as indicated by a hemoglobin A1c (HbA1c) of > 7.5% (> 59 mmol/mol)
- •23. Active psychiatric disorder including psychosis (e.g., schizophrenia), bipolar disorder, uncontrolled anxiety disorder and major depressive disorder
- •24. History of or active Cushing’s syndrome
- •25. Positive drug screen (amphetamines, barbiturates, benzodiazepines (indicated as a muscle relaxant), cocaine, opiates, tetrahydrocannabinol (THC))
- •26. Active substance abuse (drugs or alcohol), history of chronic substance abuse within the past year, or prior chronic substance abuse judged by the investigator as likely to recur during the study
- •27. Skin breakdown at the knee where the injection would take place
- •28. Women who are pregnant or nursing
- •29. Women of child-bearing potential (not surgically sterile or post-menopausal for at least 1 year as documented in medical history) not using a highly effective method of contraception (abstinence; oral, inje
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