NCT00604539已完成3 期
Study of the Effect of Chondroitin Sulphate on Synovial Inflammation in Patients With Osteoarthritis of the Knee
Bioiberica4 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2008年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Evaluation of the change in the severity of synovitis measured by MRI according to the modified methods of Loeuille et al. after chondroitin sulphate treatment in patients with knee OA and clinical signs of synovitis
研究概览
简要总结
The purpose of this study is to determine the effect of a chondroitin sulphate conventional treatment on the degree of severity of synovitis, as measured by magnetic resonance in patients with knee OA with clinical synovitis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary OA of the knee according to ACR with synovitis criteria (warmth, swelling or effusion);
- •OA of radiological stages 2 and 3 according to Kellgren-Lawrence;
- •Minimum joint space width ≥2 mm in the medial femorotibial compartment on standing knee X-ray;
- •VAS of pain while walking ≥40 mm.
排除标准
- •Known allergy to chondroitin sulphate;
- •Progressive or serious pathologies (cancer, AIDS,...);
- •Other bone and articular diseases (antecedents and/or current signs) such as chondrocalcinosis, Paget's disease, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, hemochromatosis, Wilson's disease, osteochondromatosis;
- •Corticosteroids (oral, injectable), indomethacin, therapeutic dose of glucosamine or chondroitin sulphate during the 12 weeks preceding inclusion;
- •Hyaluronic Acid (intra-articular pathway) during the 26 weeks preceding inclusion;
- •Radioactive synovectomy during the 12 weeks preceding inclusion;
- •If the patient is receiving NSAID at baseline (D0), it should be maintained at a stable dosage as much as possible from D0 to D
- •In the open phase of the study (D180 to D360), NSAID will also be allowed as rescue medication along with acetaminophen.
研究组 & 干预措施
1
Experimental
Chondroitin sulphate
干预措施: Chondroitin sulphate (Condrosan) (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluation of the change in the severity of synovitis measured by MRI according to the modified methods of Loeuille et al. after chondroitin sulphate treatment in patients with knee OA and clinical signs of synovitis
时间窗: One year
次要结局
- Tolerability(One year)
- Changes of cartilage volume and subchondral bone lesions(One year)
- Pain measured by VAS(One year)
- WOMAC index(One year)
- SF-36 Health Questionaire(One year)
- Assessment of joint swelling, effusion(One year)
- Use of rescue medication(One year)
- Adverse events(One year)
研究者
研究点 (4)
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