EUCTR2007-004973-25-PL进行中（未招募）不适用
Prospective multicentric open clinical study comparing the efficacy and safety of piascledine 300 plus standard treatment versus standard treatment only in patients with osteoarthritis of the knee - PRAGMA-PIAS STUDY
aboratoire Expanscience0 个研究点目标入组 300 人开始时间: 2008年4月7日最近更新:
适应症
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
- 300
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
- •Female of male outpatients aged 45 years or more suffering from femoro-tibial osteoarthritis of the knee uni- or bi-compartmental, uni- or bilateral and/or femoro-patellar, ptrogressing for at least 6 months, with overall pain assessed between 25 and 50 mm (VAS) in spite of daily intake of Diclofenac 75 to 150 mg/day or equivalent for at least 10 days per month and for at least 3 months prior to inclusion
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Articular chondrocalcinosis known in advance or defined by the presence of a calcic edging on at least one femoral-tibial articular space
- •Known symptomatic hip osteoarthritis (coxarthrosis) homolateral to the osteoarthritis of the knee
- •Osteoarthritis of the knee indicating for a surgical intervention during or before the trial or
- •Treatment with SYSADOA, hyaluronic acid injections within 3 months before study start
研究者
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