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2008年4月7日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Osteoarthritis of the knee
- 发起方
- aboratoire Expanscience
- 入组人数
- 300
- 状态
- 进行中（未招募）
- 最后更新
- 11年前
概览
简要总结
暂无简介。
研究者
入排标准
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
结局指标
主要结局
未指定
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