NCT01257386已完成3 期
Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis
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
- 251
- 试验地点
- 1
- 主要终点
- Reduction degree of UC-DAI
研究概览
简要总结
To demonstrate that import Mesalazine (Asacol®) is non-inferior to the reference drug, marketed Mesalazine, regarding the primary endpoint (reduction of UC-DAI score)in patients with active ulcerative colitis (UC) treated for 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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Ulcerative Colitis (UC) at active phase who are defined to show Ulcerative Colitis-Disease Activitiy Index (UC-DAI) score of 3 or higher but 8 or less, and bloody stool score of 1 or higher
排除标准
- •Patients with serious or higher according to diagnostic critera of seriousness and patients with chronic persistent type and with acute serious type in the classification by clinical course
研究组 & 干预措施
Asacol®
Experimental
Import Mesalazine
干预措施: Asacol® (Drug)
Mesalazine
Active Comparator
Marketed Mesalazine
干预措施: Mesalazine (Drug)
结局指标
主要结局
Reduction degree of UC-DAI
时间窗: Week 8
次要结局
- 1) Reduction degree of score of each UC-DAI item 2) Remission rate 3) Effective rate(Week 8)
研究者
研究点 (1)
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