NCT02142634已完成3 期
Randomised, Double-blind, Placebo-controlled, Multi-centre Trial on the Efficacy and Safety of Budesonide for Induction of Remission in Incomplete Microscopic 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
- 44
- 试验地点
- 2
- 主要终点
- Rate of clinical remission
研究概览
简要总结
The purpose of this study is to demonstrate the efficacy of budesonide for the treatment of active incomplete microscopic 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically established diagnosis of incomplete microscopic colitis (MCi)
- •History of chronic non-bloody, watery diarrhoea
- •Clinically active disease
排除标准
- •Other significant abnormalities in colonoscopy
- •Infectious cause of diarrhoea
- •Clinical suspicion of drug-induced diarrhoea
- •Prior and present MC
- •History of bowel resection
- •Radiation therapy of the abdominal or pelvic region
- •Positive antibody titres for celiac disease
- •Untreated active thyroid dysfunction
- •Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder reducing life expectancy
- •Abnormal hepatic function
- •Tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured
- •History of colorectal cancer
- •History of cancer (other than colorectal) in the last 5 years
- •Therapy with immunomodulators/budesonide or other steroids/antibiotics/anti-diarrhoeal drugs
- •Current or intended pregnancy or breast-feeding
- •Doubt about the patient's cooperation, e.g. because of addiction to alcohol or drugs
- •Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
研究组 & 干预措施
A
Experimental
Budesonide granules 9 mg
干预措施: Budesonide granules 9 mg (Drug)
B
Placebo Comparator
Placebo granules
干预措施: Placebo granules (Drug)
结局指标
主要结局
Rate of clinical remission
时间窗: 8 weeks
次要结局
- Rate of clinical remission(6 weeks)
- Number of days with abdominal pain(8 weeks)
- Number of days with urgency(8 weeks)
- Rate of histological remission(8 weeks)
- Time to remission(8 weeks)
- Number of formed/soft/watery stools per week(8 weeks)
- Physician's global assessment at final visit(8 weeks)
- Quality of life(8 weeks)
研究者
研究点 (2)
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