NCT01209208已完成3 期
Double-blind, Double-dummy, Randomised, Placebo-controlled, Multi-centre Phase III Study on the Efficacy and Tolerability of a 8-week Treatment With Budesonide vs. Mesalazine vs. Placebo in Patients With Lymphocytic Colitis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Rate of clinical remission
研究概览
简要总结
The purpose of this study is to determine whether budesonide or mesalazine is more active 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Symptoms and signs of indication of lymphocytic colitis
排除标准
- •Infectious diarrhoea,
- •Diarrhoea as a result of the presence of other symptomatic organic disease(s) of the gastrointestinal tract or endoscopic-histological findings Celiac disease
- •Pregnancy or breast-feeding,
- •Participation in an other clinical trial
研究组 & 干预措施
A
Experimental
Budesonide
干预措施: Budesonide (Drug)
B
Experimental
Mesalazine
干预措施: Mesalamine (Drug)
C
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Rate of clinical remission
时间窗: 8 weeks
次要结局
- Proportion of patients with histological improvement(8 weeks)
研究者
研究点 (1)
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