EUCTR2009-010921-38-NL进行中（未招募）不适用
Chemopreventive effects of 5-ASA and UDCA in Ulcerative Colitis:A Double-blind, Randomized Placebo-controlled Pilot Study - CRC chemoprevention in UC
MC Utrecht0 个研究点开始时间: 2009年3月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Clinical activity index = 4
- •Long-standing extensive or left-sided ulcerative colitis for more than 8 years
- •Age 18-65 years
- •Using 6-mercaptopurine or azathioprine to maintain remission
- •For women only: sufficient anti-conception
- •Signed informed consent
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Dysplasia or colorectal cancer before study entry
- •- Coexistent liver disease (Primary Sclerosing Cholangitis (PSC), chronic hepatitis B or C infection)
- •- Colectomy
- •- Family history of colorectal cancer
- •- Symptomatic cholelithiasis
- •- Cholecystitis
- •- Coagulation disorder or use anticoagulants that can not be temporarily discontinued, precluding the taking of biopsies
- •- Chronic renal impairment/failure
- •- Diabetes mellitus (higher risk for developing renal disease)
- •- Hypertension (higher risk for developing renal disease)
- •- Allergy to 5-ASA or UDCA
- •- Vertricular/gastric or duodenal ulcera
- •- For women only: Pregnancy, lactation or childbearing potential without adequate contraception
- •- Galactose-intolerance, Lapp lactasedeficience or glucose-galactose malabsorption
- •- Treatment with antacids containing hydroxide, hypolipidemics, high-dose calcium supplements (= 1200 mg/day), or any other medication disturbing the enterohepatic circulation
- •- Treatment with methotrexate, riphampicine, lactulose, glucocorticosteroids
- •- Unwillingness to be informed about accidental diagnostic findings
研究者
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