EUCTR2007-001014-17-DE进行中（未招募）不适用
A Phase II, multicentre, double-blind, randomized, dose range finding placebo controlled study of Rifaximin- EIR tablet: clinical effectiveness and tolerability in the treatment of moderate, active Crohn’s disease
Alfa Wassermann S.p.A.0 个研究点目标入组 424 人开始时间: 2008年3月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 424
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
- •patients of either sex;
- •patients aged between 18 and 75 years old, inclusively;
- •diagnosis of Crohn's disease localised in the ileum and/or colon, documented either radiologically or endoscopically at least 3 months previously;
- •patients with a CDAI of = 220 to = 400;
- •patients capable of and willing to conform to the study protocol;
- •patients who have provided signed and dated written 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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •patients potentially needing immediate surgery for Crohn's disease, including patients with occlusive symptoms and/or stenotic tract with dilation above;
- •patients with active perianal Crohn’s disease;
- •patients with other infectious, ischemic, or immunological diseases with gastrointestinal involvement;
- •patients with symptoms attributed to Short Bowel Syndrome or previous surgery;
- •patients with stoma;
- •patients affected by upper gastro-intestinal disease (gastro-duodenum-jejunum Crohn’s disease) alone or in combination with colitis or ileitis;
- •patients treated with:
- •- oral steroids and budesonide less than 30 days prior to screening;
- •- i.v. steroids less than 30 days prior to screening;
- •- antibiotics (such as metronidazole, tinidazole, ciprofloxacin, clarithromycin) less than 15 days prior to screening;
- •- rectal steroids less than 30 days prior to the screening visit;
- •- anti-tumour necrosis factor (anti-TNF) and other biological therapies less than 6 months prior to the screening visit;
- •pregnant women or nursing mothers;
- •females of childbearing age (unless surgically sterile) without a negative urine pregnancy test at screening and at enrolment;
- •patients with severe hepatic insufficiency (Child C);
- •patients with severe cardiac insufficiency (NYHA - New York Heart Association classes 3 – 4);
- •patients with known hypersensitivity to Rifaximin;
- •any condition or circumstance that would prevent completion of the study or interfere with analysis of study results, including a history of drug or alcohol abuse, mental illness or non-compliance with treatments or visits, with immunological (including HIV infection), haematological or neoplastic disease;
- •withdrawal of informed consent;
- •patients who have used any investigational drug (except biological therapies) within 3 months prior to screening;
- •patients who have donated 250 ml or more of blood in the last 3 months.
研究者
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