NCT02183129已完成4 期
Open Label Study to Assess the Efficacy and Safety of Meloxicam 7.5mg vs. Diclofenac 100mg SR 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
- 91
- 主要终点
- Change from baseline in pain on active movement assessed by a 100 mm visual analogue Scale (VAS)
研究概览
简要总结
To assess the efficacy and safety of meloxicam 7.5mg once daily compared with diclofenac 100mg SR once daily over a treatment period of 8 weeks
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（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)
Diclofenac
Active Comparator
干预措施: Diclofenac (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 (VAS)
时间窗: Baseline, 8 weeks after first drug administration
次要结局
- Number of patients with Adverse Events(Up to 8 weeks after first drug administration)
- Number of patients with significant changes from baseline in physical examinations(Baseline, 8 weeks after first drug administration)
- Change from baseline in Lequesne index(Baseline, 8 weeks after first drug administration)
- Change from baseline in global assessment by the patient and doctor on a 3-point scale(Baseline, 8 weeks after first drug administration)
- Number of patients with significant changes from baseline in Laboratory values(Baseline, 8 weeks after first drug administration)
研究者
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