NCT02323451Unknown4 期
A Multicentre, Randomized, Double-blinded, Parallel-controlled, Non-inferiority Clinical Study Of Safety and Efficacy Of Medical Chitosan for Knee Osteoarthritis Compared With Sodium Hyaluronate Injection
Shanghai Qisheng Biological Preparation Co., Ltd.1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2014年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale for knee pain
研究概览
简要总结
This study evaluates the safety and efficacy of investigational products in the treatment of knee Osteoarthritis. Half of participants will receive medical chitosan, while the other half will receive sodium hyaluronate.
详细描述
Medical chitosan and sodium hyaluronate each form the reticular layer to cover the joint surface, alleviate the joint friction and pain. For medical chitosan, its half-life is longer than sodium hyaluronate, so the interval time of intra-articular injection is longer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females at the age of 40-75 years old
- •Conforming to the diagnosis standard of the American College of Rheumatology in 2009： knee pain and osteophyte determined with X-ray, and at least one of the following items：
- •above 50 years old
- •morning stiffness less than 30 minutes
- •knee joint with fricative when moving
- •The studying knee has score of 40-90 mm on a 100 mm measured VAS and the other side was less than 40mm when walking on flat ground.
- •The studying knee has score of 1, 2 or 3 determined by radiological Kellgren-Lawrence grading scale.
- •Patients who have treatment requirements and can obey the therapeutic schedule
- •Body mass index(BMI) ≤35kg/m2。
- •Able to follow the clinical observation and follow up.
- •The subjects are able to understand and sign the informed consent after fully understand this study, the disease, investigational drugs, the therapeutic schedule and the potential risks.
排除标准
- •Positive signs of swelling or floating patella test，and there are obvious effusion of knee joint in clinical.
- •Other inflammatory pain diseases of knee joint, such as rheumatism/ rheumatoid arthritis, psoriatic arthritis, gout, hemophilic arthritis, etc.
- •Pain diseases of knee joint, except for osteoarthritis, such as intra-articular tumor, villonodular synovitis, joint trauma, etc.
- •Pregnant or lactating females.
- •Participants who suffer from serious cardiovascular disease (Sudden cerebral infarction with sequela or myocardial infarction within recent 6 months), hepatic disease, kidney disease；Participants whose ALT and AST are twice or more than twice than that of the upper limit of normal value；Participants whose serum creatinine exceed the upper limit of normal value；Participants who suffer from dysfunction of blood coagulation (thrombocytopenia, bleeder disease, etc.)
- •Participants who have systemic infection or infectious disease.
- •Participants who suffer from serious skin defect or ulcer around the studying knee joint.
- •Participants who suffer from typical varus or valgus deformities or lack of articular cavity.
- •Participants with diabetes and have to inject insulin or who are not good enough to control the blood glucose (FBG ( fasting blood-glucose) ≥10mmol/L.)
- •Participants who suffer from cancer (within 5 years) or Alzheimer's disease.
- •Participants with score 0 or 4 of the studying knee joint evaluated by radiological Kellgren-Lawrence grading scale.
- •Participants who have hormone drugs within 2 weeks or analgesic drugs within 1 week before this trial or take part in other clinical trials.
- •Participants whose studying knee receives articular cavity therapy within 3 months, containing intra articular administration, articular irrigation and arthroscopic surgery
- •Participants with an allergy to the experimental drugs.
- •Participants who are not suitable for this trial judged by the researchers.
研究组 & 干预措施
Medical Chitosan
Experimental
Medical Chitosan, 2ml/vial (12mg/ml), intra-articular injection with a volume less than 2ml every two weeks, a total of 3 times
干预措施: Medical Chitosan (Device)
Sodium Hyaluronate Injection
Active Comparator
Sodium Hyaluronate Injection, 2ml/vial (10mg/ml), intra-articular injection with a volume less than 2ml every one weeks, a total of 5 times.
干预措施: Sodium Hyaluronate Injection (Drug)
结局指标
主要结局
Visual Analogue Scale for knee pain
时间窗: six weeks of the initial injection
The investigator and the subject both evaluate the pain intensity per VAS before injection. VAS ranges from o to 10, 0=no pain, 10=pain as bad as can be.
次要结局
- WOMAC for knee pain(six weeks of the initial injection)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
E1K Intra Articular(IA) Treatment for Knee OsteoarthritisOsteoarthrosisNCT05697952Ensol Bioscience120
Unknown
3 期
A Phase 3 Study to Assess the Efficacy and Safety of PK101 in Patients With Knee OsteoarthritisKnee OsteoarthritisNCT04858659PMG Pharm Co., Ltd354
已完成
2 期
Osteoarthritis of the Knee, Inflammation, and the Effect of Adalimumab (OKINADA)Osteoarthritis, KneeNCT02471118CARE ARTHRITIS LTD.62
已完成
不适用
Observational Study on the Treatment of Knee Osteochondral Lesions of Grade III-IVDegenerative Lesion of Articular Cartilage of KneeNCT01554878Ettore Sansavini Health Science Foundation20
已完成
1 期
Multiple Ascending Doses (MAD) of Anti-A Disintegrin and Metalloproteinase With Thrombospondin Motifs-5 (Anti-ADAMTS-5) Nanobody in Participants With Knee Osteoarthritis (OA)Osteoarthritis, KneeNCT03583346Merck KGaA, Darmstadt, Germany32