EUCTR2010-018686-36-DE进行中（未招募）不适用
Agio-Prep 3g versus Agio-Prep 6g versus Moviprep® - a prospective, randomised, controlled evaluation of bowel cleansing for colonoscopy - Bowel preparation with Agio-Prep
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
- Madaus GmbH
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
- •Gender: male/female
- •Age: =18 years
- •Scheduled for colonoscopy
- •Subjects eligible for colorectal cancer screening
- •Good state of health (no clinically significant deviations from normal clinical results and laboratory test findings)
- •The subject must give written informed consent, after having been informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the subjects participating in the study
- •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
- •Subjects scheduled for emergency colonoscopy
- •Subjects with unclear/undiagnosed abdominal pain and discomfort
- •Laboratory values out of normal range unless the deviation from normal is judged as clinically not relevant by the investigator
- •Existing severe cardiac, renal, metabolic or haematological diseases and/or pathological findings, which might interfere with the drug's safety, tolerability, and bowel preparation procedure
- •Existing gastrointestinal diseases and/or pathological findings, which might interfere with the drug's safety, tolerability, and bowel preparation procedure
- •Subjects who had previous colonic resection surgery
- •Known GI atresia or stenosis
- •Suspicion of ileus, subileus
- •Known coagulopathy
- •Instable Diabetes mellitus
- •Acute inflammatory bowel diseases (e.g. Crohn’s disease, ulcerative colitis, acute appendicitis)
- •History of renal insufficiency
- •Severe electrolyte disturbance, dehydration
- •History of severe CNS and psychiatric disorders
- •History of or current drug or alcohol abuse
- •Use of drugs during the last week prior to the intended administration that can influence bowel transit times (e.g. laxatives, stool softeners, promotility agents, products to prevent diarrhoea, purgatives and enemas)
- •Known intolerance and/or allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations (polyethylene glycol, sodium sulfate, sodium chloride, potassium chloride, sodium ascorbate, ascorbic acid, Plantago ovata seeds, Tinnevelly-senna pods, sucrose)
- •Subjects suspected or known not to follow instructions
- •Subject is, at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or increased alcohol consumption or dependence
- •Subject does not agree to abstain from alcohol for 24 hours prior to start of procedure
- •Subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study
- •Participation in a clinical trial during the last month prior to the start of the study
- •Vulnerable subjects
- •The exclusion criteria are chosen to assure that subjects with specific risks for the procedure and administration of the investigated drug are excluded.
研究者
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