NCT01781702已完成3 期
A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients
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
- 120
- 主要终点
- Changes in '100 mm pain VAS' value from baseline
研究概览
简要总结
A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males/Females aged 18~80 years
- •Patient who are taking NSAIDs for the treatment of rheumatoid arthritis
- •Patients who belong to ACR functional class 1, 2, 3
排除标准
- •Patients who belong to ACR functional class 4
- •Patients who are hypersensitive to clinical trial medicines or excipient
- •Patients who have experience of Cerebrovascular bleeding, bleeding disorder
研究组 & 干预措施
Pelubiprofen 30 mg
Experimental
Pelubiprofen 30 mg, tid
干预措施: Pelubiprofen 30 mg (Drug)
Celebrex 200 mg
Active Comparator
Celebrex 200 mg, tid
干预措施: Celebrex 200 mg (Drug)
结局指标
主要结局
Changes in '100 mm pain VAS' value from baseline
时间窗: -14, 0, 14, 28, 42 day
次要结局
未报告次要终点
研究者
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