NCT00528073已完成2 期
A Phase II, Multicentre, Double-blind, Randomised, Dose Range Finding Placebo Controlled Study of Rifaximin-EIR Tablet: Clinical Effectiveness and Tolerability in the Treatment of Moderate, Active Crohn's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 410
- 试验地点
- 57
- 主要终点
- Clinical remission (Crohn's Disease Activity Index < 150 points)
研究概览
简要总结
This study aims to determine which of 3 doses of a non-absorbable antibiotic Rifaximin is most effective in treating active moderate Crohn's disease. Rifaximin tablets are already marketed in some European countries and the USA to treat traveller's diarrhoea. A new gastro-resistant form of Rifaximin called Rifaximin-Extended Intestinal Release (EIR) will be used in this study. These tablets dissolve in the stomach,releasing gastro-resistant granules which pass into the intestines and deliver Rifaximin directly to the site of the disease. Rifaximin is not absorbed, making it more effective and greatly reducing the frequency of side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
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.
研究组 & 干预措施
A
Experimental
Rifaximin-EIR tablet 1x400 mg + Placebo 2 tablets bid
干预措施: Rifaximin-EIR (Drug)
B
Experimental
Rifaximin-EIR tablet 2x400 mg + Placebo 1 tablet bid
干预措施: Rifaximin-EIR (Drug)
C
Experimental
Rifaximin-EIR tablet 3x400 mg bid
干预措施: Rifaximin-EIR (Drug)
D
Placebo Comparator
Placebo 3 tablets bid
干预措施: Rifaximin-EIR (Drug)
结局指标
主要结局
Clinical remission (Crohn's Disease Activity Index < 150 points)
时间窗: After 12 weeks of treatment
次要结局
- Time to obtain clinical response and remission(During the 12 weeks of treatment)
- Maintenance of clinical remission(12 weeks after the end of the 12 weeks of treatment)
- Number of treatment failures(During the 12 weeks of treatment)
- Clinical response (reduction of baseline CDAI score by 100 points or more)(Any time during the 12 weeks of treament)
- Clinical response (reduction of baseline CDAI by 70 points or more)(At any time during the 12 weeks of treatment)
- Definition of therapeutic dose to be used in subsequent phase III trials.(After statistical analysis of the results)
- Adverse events(Throughout the study)
研究者
研究点 (57)
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