NL-OMON45182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 - BUG-3/MIC
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 (MCi) defined as the following findings in at least two segments of the colon:
- •* increased lymphoplasmacellular infiltrate in the lamina propria and
- •* thickened subepithelial collagenous band > 5 *m and < 10 *m and/or
- •* abnormal intraepithelial lymphocytes > 5 and < 20 per 100 epithelial cells,
- •4. History of chronic non-bloody, watery diarrhoea for at least 4 weeks,
- •5. Clinically active disease (defined as a mean of * 3 stools/day, thereof a mean of * 1 watery stool/day during the week prior to randomisation),
- •6. Women of child-bearing potential have to apply during the entire duration of the study a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, some IUDs, sexual abstinence or vasectomised
- •partner. The investigator is responsible for determining whether the patient uses adequate birth control for study participation.
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,
- •6. Radiation therapy of the abdominal or pelvic region,
- •7. Positive antibody titres for celiac disease (tGT IgA + serum IgA),
- •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, and spasmolytics 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.
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