NCT00451360已完成3 期
Evaluation of the CHOndromodulating Effect of DIAcerein in Osteoarthritis of the Hip. ECHODIAH.
Laboratoires NEGMA49 个研究点 分布在 1 个国家目标入组 500 人开始时间: 1993年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 49
- 主要终点
- Joint space measurement
研究概览
简要总结
We carried out a 3 years, randomized, double-blind, placebo-controlled, multicenter clinical trial in patients with hip osteoarthritis in order to:
- evaluate the ability of diacerein, an interleukin-1β inhibitor, to slow the progressive decrease in joint space width observed in patients with hip osteoarthritis
- to investigate the potential structure-modifying effect of diacerein in patients with hip osteoarthritis
This study compare also after ten years the percentage of patients in each treatment group who require a hip replacement surgery
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
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients fulfilling the American College of Rheumatology criteria for the diagnosis of hip osteoarthritis.
- •Lequesne algofunctional index of at list 3 points.
- •Radiographic criterion for inclusion: joint space width (JSW) between 1 mm and 3 mm. If the JSW exceeded 3 mm, it had to be at least 0.5 mm thinner than JSW of the contra lateral hip, measured at its narrowest point.
排除标准
- •Intraarticular injection or arthroscopy of the hip during the three months prior to inclusion in the study.
- •Any systemic or intraarticular corticosteroid as well as other potential symptom-modifying drugs for osteoarthritis were not allowed during the study.
结局指标
主要结局
Joint space measurement
次要结局
- Requirement of hip replacement surgery after ten years
- Tolerability
研究者
研究点 (49)
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