NCT00446849已完成4 期
A Phase IV, Multi-center, Open-label Study to Assess Clinical Recurrence Related to Compliance With Treatment With MMX Mesalamine 2.4g/Day Given Once Daily for the Maintenance of Quiescent Ulcerative Colitis (UC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 290
- 试验地点
- 62
- 主要终点
- Clinical Recurrence of Ulcerative Colitis (UC) During the Maintenance Phase at 6 Months
研究概览
简要总结
To evaluate the percentage of subjects with clinical recurrence of UC at 6 months using MMX mesalamine once daily.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
MMX Mesalamine
Experimental
干预措施: MMX Mesalamine (Drug)
结局指标
主要结局
Clinical Recurrence of Ulcerative Colitis (UC) During the Maintenance Phase at 6 Months
时间窗: 6 months
Clinical recurrence is defined as 4 or more bowel movements per day above the subject's normal frequency and associated with any of the following: urgency, abdominal pain, or rectal bleeding.
次要结局
- Clinical Recurrence of UC During the Maintenance Phase Associated With Subject Compliance at 12 Months(12 months)
- Quiescent UC During the Maintenance Phase at 12 Months(12 Months)
- Clinical Recurrence of UC During the Maintenance Phase at 12 Months(12 Months)
- Endoscopic Remission of UC During the Maintenance Phase at 12 Months(12 Months)
- Clinical Recurrence of UC During the Maintenance Phase Associated With Subject Compliance at 6 Months(6 Months)
研究者
研究点 (62)
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