NCT01257399已完成3 期
Comparative Efficacy and Safety Study in Patients With Ulcerative Colitis in Remission Phase
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
- Rate of non-emergence of bloody stool
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 (rate of non-emergence of bloody stool), in patients with Ulcerative Colitis in remission, treated for 48 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 in remission who are defined to show an Ulcerative Colitis-Disease Activity Index (UC-DAI) score of 2 or less and a bloody stool score of 0.
排除标准
- •Patients who take adrenal corticosteroid (oral formulation, enemas, suppository, agents for hemorrhoidal disease, injectable solution) within 14 days before start of administration of clinical study drug.
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
Rate of non-emergence of bloody stool
时间窗: Week 48
次要结局
- 1) Period of non-emergence of bloody stool, 2) Rate of non-recurrence, 3) Period of non-recurrence, 4) Reduction of UC-DAI score(Week 48)
研究者
研究点 (1)
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