NCT00139165Unknown3 期
Long-Term Treatment of Collagenous Colitis With Budesonide. Prospective, Doubleblind Placebo-Controlled Trial.
Bonderup, Ole K., M.D.3 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2004年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Clinical symptoms
研究概览
简要总结
The aim of the trial is to examine the effect of budesonide treatment on collagenous colitis. All patients is treated for 6 weeks with budesonide and thereafter randomised to 24 weeks treatment with placebo or continued budesonide. The end poit is effect on clinical symptoms (number of daily stools)
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
- Double
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
- •Histological criteria of Collagenous colitis
- •Clinical activity (> 3 stools/day)
排除标准
- •Treatment of Collagenous colitis within the last 3 months
结局指标
主要结局
Clinical symptoms
次要结局
- Histological changes
研究者
研究点 (3)
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