NCT00450086已完成3 期
Double-blind, Double-dummy, Randomised, Placebo-controlled, Multi-centre Phase III Clinical Study on the Efficacy and Tolerability of Budesonide Capsules vs. Mesalazine Granules vs. Placebo for Patients With Collagenous Colitis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Rate of clinical remission (<= 3 stools per day) after 8 weeks
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 collagenous colitis.
详细描述
This study will check the reproducibility of the results reported in trials with budesonide in patients with collagenous colitis. Efficacy of mesalazine was never tested in collagenous colitis by placebo-controlled trials. This trial will check the superiority of mesalazine over placebo using the common clinical symptom of collagenous colitis, which is chronic or recurrent non-bloody, watery diarrhea.
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 80 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
- •Evidence of infectious diarrhea
- •Celiac disease
- •Endoscopic-histologic findings, which may have caused diarrhea
- •History of partial colonic resection
- •Diarrhea as a result of the presence of other symptomatic organic disease of the gastrointestinal tract
- •Active colorectal cancer or a history of colorectal cancer
- •Severe co-morbidity substantially reducing life expectancy
- •Abnormal hepatic function or liver cirrhosis (ALT, AST or AP >= 2 x ULN)
- •Abnormal renal function (Cystatin C > ULN)
- •Active peptic ulcer disease, local intestinal infection
- •Asthma, diabetes mellitus, infection, osteoporosis, glaucoma, cataract, or cardiovascular disease if careful medical monitoring is not ensured
- •Hemorrhagic diathesis
研究组 & 干预措施
A
Experimental
干预措施: Budesonide (Drug)
B
Experimental
干预措施: Mesalazine (Drug)
C
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Rate of clinical remission (<= 3 stools per day) after 8 weeks
时间窗: 8 weeks
次要结局
- Rate of clinical remission (<= 3 stools per day) after 2 weeks(2 weeks)
- Time to remission
- Impact on stool consistency (watery/soft/solid)(8 weeks)
- Impact on abdominal pain(8 weeks)
- Impact on patient's general well-being(8 weeks)
- Effect on histopathology(8 weeks)
- Severity of diarrhea(8 weeks)
- QoL(8 weeks)
- PGA(8 weeks)
研究者
研究点 (1)
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