EUCTR2013-001912-31-DK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
- 106
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
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 except for colonic diverticulosis and non-dysplastic polyps < 2 cm,
- •2. Infectious cause of diarrhoea (local routine stool samples, Clostridium difficile included) or history of infectious diarrhoea within the last 3 months prior inclusion or local intestinal infection,
- •3. Clinical suspicion of drug-induced diarrhoea,
- •4. Prior and present MC (i.e., all histological criteria for collagenous colitis or lymphocytic colitis fulfilled),
- •5. History of bowel resection (except appendectomy, haemorrhoidectomy and endoscopic removal of polyps),
- •6. Radiation therapy of the abdominal or pelvic region,
- •7. Positive antibody titres for celiac disease (tGT IgA + serum IgA), or any known history of celiac disease,
- •8. Untreated active thyroid dysfunction,
- •9. Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder reducing life expectancy,
- •10. Abnormal hepatic function (ALT or ALP > 2.5 x upper limit of normal [ULN]), liver cirrhosis, or portal hypertension,
- •11. Tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer disease, glaucoma, cataract, or infection if careful medical monitoring is not ensured,
- •12. History of colorectal cancer,
- •13. History of cancer (other than colorectal) in the last 5 years,
- •14. Therapy with immunomodulators (e.g., azathioprine, 6-mercaptopurine, or methotrexate) within 3 months prior to baseline,
- •15. Treatment with budesonide or other steroids within 4 weeks prior to baseline,
- •16. Treatment with antibiotics within 4 weeks prior to baseline,
- •17. Treatment with anti-diarrhoeal drugs (e.g., loperamide, ispaghula, codeine, and opium), cholestyramine, bulking agents, spasmolytics, bismuth, and probiotics within 2 weeks prior to baseline,
- •18. Known intolerance/hypersensitivity/resistance to the trial drug or drugs of similar chemical structure or pharmacological profile,
- •19. Current or intended pregnancy or breast-feeding,
- •20. Doubt about the patient’s cooperation, e.g. because of addiction to alcohol or drugs,
- •21. Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial,
- •22. Live vaccination within the last 4 weeks before the baseline visit,
- •23. Diagnosis of chickenpox, herpes zoster or measles within the last 3 months before the baseline visit.
研究者
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