NCT04358120已完成不适用
A Multicentre Clinical Investigation to Assess Efficacy and Safety of Intra-articular Injections of a New Viscosupplement Based on Hyaluronic Acid Combined With Chondroitin Sulfate in Patients With Knee Osteoarthritis
Fidia Farmaceutici s.p.a.5 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2017年11月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 5
- 主要终点
- Change in pain score measured by Visual Analogue Scale (VAS)
研究概览
简要总结
This is a multicentre, prospective, sponsor initiated clinical investigation that aims to evaluate safety and efficacy of Hyaluronic Acid Combined With Chondroitin Sulfate in symptomatic patients with OA of the knee.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At Screening
- •Male or female between the ages of 40 and 80
- •Body Mass Index (BMI) ≤ 30;
- •Mean knee pain score at rest over the last 24 hours evaluated on VAS (0-100) ≥
- •The most painful knee is considered the target knee;
- •OA of the Knee radiologically and clinically confirmed responding to criteria of American College of Rheumatology (ACR): pain of the knee and crepitus on active motion or morning stiffness less than 30 minutes or age >50 years
- •Symptomatic knee pain for more than 6 months;
- •Radiological Kellgren and Lawrence grade II or III confirmed by an X-ray not older than 12 months;
- •Willing to discontinue any systemic analgesic/NSAID therapy, opioids, systemic corticosteroids, skeletal muscle relaxants, and any other medication that would interfere with the study assessments, except for the rescue medication, with no intention to resume them during the clinical investigation (see Appendix 5 for wash out period);
- •Patient able to comply with the instructions of the clinical investigation and to maintain a Rescue Medication Diary during the study;
- •Having signed the study informed consent.
- •at Baseline
- •Patient does not have chondromatosis or villonodular synovitis of the knee evaluated by Ultrasound;
- •Patient has complied with the requirements for rescue medication (no more than 6 tablets or 3 grams of paracetamol per day up to 4 days per week and paracetamol discontinued 24 hours before first IA injection);
- •Mean knee pain score at rest over the last 24 hours evaluated on VAS (0 - 100) ≥ 40 (with a washout period for Paracetamol of 24 hours);
- •Patient has discontinued prior to Baseline the use of all prohibited medications in accordance with the washout period defined in Appendix 5;
- •Patient continues to meet all Screening inclusion/
排除标准
- •at the Baseline visit.
- •Exclusion Criteria:
- •Related to the OA pathology
- •Recent trauma (< 1 month) of the target knee responsible for the symptomatic knee pain;
- •Articular disease resulting from articular dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, haemophilia, hemochromatosis;
- •Inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, gout and infectious arthritis, acute calcium pyrophosphate arthritis);
- •Pathologies interfering with the evaluation of OA. Related to treatments
- •Corticosteroids injection in the target knee in the last 3 months before first intra-articular (IA) injection;
- •Hyaluronan injection in the target knee in the last 6 months before first IA injection;
- •Arthroscopy and surgery in the target knee in the last 3 months before first IA injection;
- •Oral corticosteroid therapy ≥ 5mg/day (in Prednisone equivalent) in the last 3 months before first IA injection;
- •OA treatments based on curcuma extract in the last 3 months before first IA injection;
- •Change in the dosage of symptomatic slow-acting drugs (SYSADOA) e.g., chondroitin, glucosamine, diacerein or avocado-soya unsaponifiables in the last 3 months before first IA injection;
- •Contraindications to 4% GAG: hypersensitivity to the product components;
- •Infections or skin diseases in the area of the injection site;
- •Change in the dosage of ongoing non-pharmacologic therapy for the lower extremities (including physical therapy) initiated in the month before first injection;
- •Anticoagulant (coumarinic compound) and heparin. Related to associated diseases
- •Severe diseases (e.g., liver or renal failure, lung/heart disease, tumour, HIV);
- •Severe alteration of mobility interfering with the functional evaluation;
- •High risk of haemorrhage;
- •Patient with known allergy to paracetamol;
- •Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee.
- •Related to study subjects
- •Participation to a therapeutic clinical trial in the last 3 months before first injection;
- •Pregnancy, breastfeeding, planned conception and premenopausal women without contraception, tubal ligation or hysterectomy
结局指标
主要结局
Change in pain score measured by Visual Analogue Scale (VAS)
时间窗: at week 6, 14 and 26
Change in pain perception from baseline in patient with knee osteoarthritis after three intra-articular 2% Chondroitin Sulfate + 2% hyaluronic Acid injections assessed by Visual Analogue Scale (VAS) (From 0 to 100) at weeks 6, 14 and 26
次要结局
- Change from baseline up to 26 weeks after first treatment on knee functional disability on Clinical Observer Global Assessment (COGA)(at weeks 6, 14 and 26)
- Number of patients Responder to treatment(Weeks 6, 14 and 26)
- Change from baseline in popliteal cyst at 6 weeks(at week 6)
- Change from baseline in knee pain and function up to 26 weeks(at weeks 6, 14 and 26)
- Change in Patient's Global Assessment(at weeks 6, 14 and 26)
- Change from baseline in Synovitis at 6 weeks(at week 6)
- Change from baseline in Synovial hypertrophy at 6 weeks(at week 6)
- Change in Synovial Power Doppler signal at week 6(at week 6)
- Change from baseline in knee Effusion at 6 weeks(at week 6)
- Safety of the treatment. Number of patient with treatment related adverse events(through study completion)
研究者
研究点 (5)
Loading locations...
相似试验
尚未招募
不适用
Evaluation of the Diagnostic Sensitivity and Specificity of the Determine™ Syphilis Advanced Test.Syphilis InfectionNCT06584214Abbott Rapid Dx400
已完成
不适用
Coronary Crossing System in Patients With Coronary Chronic Total OcclusionsChronic Total Occlusion of Coronary ArteryNCT05813704Shanghai MicroPort Rhythm MedTech Co., Ltd.159
已完成
不适用
Coronary Intravascular Lithotripsy System in Patients With Coronary Artery Calcification (VIGOUR)Coronary Artery CalcificationNCT05818098Shanghai MicroPort Rhythm MedTech Co., Ltd.189
已完成
不适用
Safety and Effectiveness Study of the Solysafe Septal Occluder in Patients With Atrial Septum Defect and Patent Foramen OvaleAtrial Septal DefectPatent Foramen OvaleNCT00207376Carag AG
撤回
不适用
Efficacy of the Aspen Spinous Process System in Anterior Lumbar Interbody Fusion (ALIF)Degenerative Disc DiseaseNCT01016314Zimmer Biomet