NCT00180076已完成3 期
Efficacy and Safety of Budesonide in Maintenance Treatment of Collagenous 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
- 75
- 试验地点
- 2
- 主要终点
- Proportion of patients in clinical remission after 6 months
研究概览
简要总结
The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous colitis.
详细描述
The purpose of this study is to determine whether orale budesonide is effective in maintaining clinical remission in patients with collagenous 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
- •collagenous colitis
- •written informed consent
排除标准
- •infectious causes for diarrhea
- •other inflammatory bowel diseases
- •history of colonic surgery
- •celiac disease
- •malignancies
- •severe concomitant diseases
- •use of budesonide, steroids, mesalazine within the previous 2 weeks
- •known intolerance to budesonide
- •history of lack of response to budesonide
- •pregnancy,lactation
- •drug and/or alcohol abuse
- •lack of compliance
结局指标
主要结局
Proportion of patients in clinical remission after 6 months
次要结局
- time to relapse
- safety
- quality of life
- histological improvement
研究者
研究点 (2)
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