NCT00180050已完成3 期
Efficacy and Safety of Budesonide for Treatment of Lymphocytic Colitis
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Proportion of patients in clinical remission after 6 weeks
研究概览
简要总结
The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis
详细描述
The purpose of this study is to determine whether orale budesonide is effective in the treatment of lymphocytic colitis
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •lymphocytic colitis
- •effective contraception
- •written informed consent
排除标准
- •other forms if IBD
- •celiac disease
- •infectious colitis
- •history of colonic surgery
- •use of budesonide, 5-ASA, steroids within th previous 4 weeks
- •pregnancy, lactation
结局指标
主要结局
Proportion of patients in clinical remission after 6 weeks
次要结局
- safety
- quality of life
- histological improvement
研究者
研究点 (2)
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