NCT02183116已完成4 期
Open Study to Access the Efficacy and Safety of Meloxicam 7.5mg in Patients With Osteoarthritis of the Knee
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Change from baseline in pain on active movement assessed by a 100 mm visual analogue scale (100 mm, VAS)
研究概览
简要总结
To Access the Efficacy and Safety of Meloxicam 7.5mg once daily over a treatment period of 56 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 34 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis of the knee requiring the therapy with non-steroidal anti-inflammatory drugs (NSAIDs)
排除标准
- 未提供
研究组 & 干预措施
Meloxicam
Experimental
干预措施: Meloxicam (Drug)
结局指标
主要结局
Change from baseline in pain on active movement assessed by a 100 mm visual analogue scale (100 mm, VAS)
时间窗: Baseline, 8 weeks after first drug administration
次要结局
- Assessment of significant change from baseline in status according endoscopy(Baseline, 8 weeks after first drug administration)
- Change from baseline in Lequesne index(Baseline, 8 weeks after first drug administration)
- Change from baseline in physical examination (tenderness)(Baseline, 8 weeks after first drug administration)
- Assessment of significant change from baseline in gastrointestinal (GI) symptoms score(Baseline, 8 weeks after first drug administration)
- Assessment of significant change from baseline in laboratory values(Baseline, 8 weeks after first drug administration)
- Number of Patients with Adverse Events(Up to 8 weeks after first drug administration)
- Assessment of significant change from baseline in physical examination (swelling)(Baseline, 8 weeks after treatment)
研究者
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