NCT01203254终止4 期
Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease
Florian Beigel6 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 34
- 试验地点
- 6
- 主要终点
- Reduction of fluid stool > 30 %
研究概览
简要总结
The purpose of this study is to assess the efficacy of cholestagel to reduce the frequency of soft and liquid stools per day in patients with CD in clinical remission with symptoms of BAM and to assess the improvement in stool consistency and quality of life in these patients and to assess the safety of cholestagel.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（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
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Cholestagel
Active Comparator
干预措施: Colesevelam (Drug)
结局指标
主要结局
Reduction of fluid stool > 30 %
时间窗: 4 weeks after baseline
次要结局
- Improvement of Stool Consistency(4 weeks after baseline)
- Improvement of Quality of Life.(4 weeks after baseline)
- Change of median liquid or soft stool frequency/per day.(4 weeks after baseline)
研究者
Florian Beigel
Dr. med.
Klinikum der Universitaet Muenchen, Grosshadern
研究点 (6)
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