EUCTR2013-001912-31-PT进行中（未招募）1 期
Randomised, double-blind, placebo-controlled, multi-centre trial on the efficacy and safety of budesonide for induction of remission in incomplete microscopic colitis - Budesonide for induction of remission in incomplete microscopic colitis
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Signed informed consent
- •2. Man or woman between 18 and 80 years of age
- •3. Histologically established diagnosis of incomplete microscopic colitis
- •4. History of chronic non-bloody, watery diarrhoea for at least 4 weeks
- •5. Clinically active disease
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •1. Other significant abnormalities in colonoscopy that may have been the cause of diarrhoea
- •2. Infectious cause of diarrhoea
- •3. Clinical suspicion of drug-induced diarrhoea
- •4. Prior and present MC
- •5. History of bowel resection
- •6. Radiation therapy of the abdominal or pelvic region
- •7. Positive antibody titres for celiac disease
- •8. History of colorectal cancer
- •9. Therapy with immunomodulators within the last 3 months
- •10. Treatment with budesonide, other steroids or antibiotics within the last 4 weeks
- •11. Treatment with anti-diarrhoeal drugs, bulking agents, and spasmolytics within the last 2 weeks
研究者
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