EUCTR2006-005946-35-SK进行中（未招募）1 期
Efficacy and safety of 3 intra-articular injections of 500 µg icatibant in a randomized, double-blind, parallel-group, placebo-controlled 13-week multi-centre study in patients with symptomatic knee osteoarthritis, continued by an observation of safety and tolerability over a further double-blind 13-week period - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 450
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
- •Male and female subjects with painful osteoarthritis of the knee
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •. Subjects with knee OA of Kellgren & Lawrence grade < II [5] (see Appendix A)
- •· Age < 18 years
- •· Diagnosis of OA < 3 months (based on the 1986 American College of Rheumatology (ACR) diagnostic criteria [3], see Appendix A)
- •· Subjects with a low chance to meet the general knee pain score eligibility criteria for randomization at baseline (= 35 = 85 units on a 100-unit VAS)
研究者
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