NCT02183168已完成3 期
A Randomized, Open Label, 3-arm Evaluation of Efficacy and Safety of Meloxicam Suppository (15mg Daily) and Tablet (15 mg Daily) Compared to Indomethacin Suppository (50 mg Daily) in Patients With Ankylosing Spondylitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 192
- 主要终点
- Overall assessment of disease activity by the patient on VAS
研究概览
简要总结
Study to assess the efficacy and safety of meloxicam suppository 15 mg once daily, meloxicam tablet 15 mg once daily compared with Indomethacin suppository (50 mg daily) in patients with ankylosing spondylitis
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
- •Active ankylosing spondylitis (pain rated >= 40 mm on a VAS and increased of at least 30% after nonsteroidal anti-inflammatory drugs (NSAIDs) wash-out)), without peripheral arthritis and inflammatory bowel disease
排除标准
- 未提供
研究组 & 干预措施
Meloxicam suppository
Experimental
干预措施: Meloxicam suppository (Drug)
Meloxicam tablet
Experimental
干预措施: Meloxicam tablet (Drug)
Indomethacin suppository
Active Comparator
干预措施: Indomethacin (Drug)
结局指标
主要结局
Overall assessment of disease activity by the patient on VAS
时间窗: 6 weeks
Functional Index of ankylosing spondylitis of Dougados
时间窗: 6 weeks
Overall pain during the previous 48 hours assessed on a Visual Analogue Scale (VAS)
时间窗: 6 weeks
次要结局
- Global efficacy assessed by the investigator (verbal rating scale)(6 weeks)
- Assessment of Chest expansion(6 weeks)
- Assessment of Fingers - to - floor test(6 weeks)
- Duration of morning stiffness(6 weeks)
- Global efficacy assessed by the patient (verbal rating scale)(6 weeks)
- Number of study withdrawals due to lack of efficacy(6 weeks)
- Assessment of Paracetamol consumption(6 weeks)
- Assessment of Patient status with regard to disease condition(6 weeks)
- Overall assessment of disease activity by the investigator on a VAS(6 weeks)
- Evaluation of spinal pain by the investigator (verbal rating scale)(6 weeks)
- Assessment of Schober test(6 weeks)
- Assessment of Night pain (verbal rating scale)(6 weeks)
- Total number of study withdrawals(6 weeks)
研究者
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