EUCTR2015-001138-10-PL进行中（未招募）1 期
Efficacy of diosmectite (Smecta®) in the symptomatic treatment of acute diarrhoea in adults. A multicentre, randomised, double-blind, placebo-controlled, parallel groups study - ADIASE
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相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 854
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
入选标准
- •(1) Provision of written informed consent prior to any study related
- •procedures,
- •(2) male or female subject (outpatient) legally considered as an adult
- •(age of majority). In Czech Republic the upper limit of age will be 70
- •years inclusive.
- •(3) subject has a diagnosis of acute diarrhoea presumed of infectious
- •origin, defined as:
- •- the passage of 3 or more unformed loose or watery stools (rated
- •according to the Bristol scale) per day without associated alarm
- •- having started within 48 hours before Visit 1 (first study drug intake
- •(4) subject has, usually, normal bowel habits, (Rome III criteria) ** ,
- •i.e. at least 3 stools per week and no more than 3 stools per day, (5)
- •subject must be willing and able to comply with study restrictions and
- •willing to return to the clinic for the follow up evaluation(s) as specified
- •in the protocol.
- •*Symptoms considered as alarm symptoms are identified in the
- •exclusion criteria (1)
- •**Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F,
- •Spiller RC. Functional Bowel Disorders. Gastroenterology 2006;
- •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 754
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Exclusion criteria related to the acute diarrhoea episode:
- •(1) At least one of the following alarm symptoms*
- •bloody diarrhoea*,
- •pus in the stools*,
- •fever =38.0°C*,
- •moderate or severe dehydration according to World Health
- •Organisation (WHO) definition, requiring intravenous (IV) rehydration*,
- •repeated vomiting*
- •persistent abdominal pain*
- •*These symptoms are considered as alarm symptoms
- •(2) other episode of acute watery diarrhoea within the previous 30 days,
- •(3) persistent diarrhoea, defined as acutely starting episode of diarrhoea
- •lasting more than 14 days,
- •(4) history of chronic diarrhoea (Rome III criteria); i.e. 3 or more loose
- •or watery stools per day for at least 12 weeks, consecutive or not, in the
- •preceding 12 months,
- •(5) traveller's diarrhoea defined as a diarrhoeal episode due to
- •contamination experienced by subjects having travelled in at risk
- •countries, or coming from abroad and experiencing locally an acute
- •diarrhoea episode, occurring usually within the first 2 weeks of the stay
- •in a foreign environment.
- •Exclusion criteria related to drugs:
- •(6) Diarrhoea suspected to be induced by drug for example:
- •antibiotic therapy, including Clostridium difficile-induced diarrhoea,
- •within 1 week before entry in the study,
- •laxative agent
- •thyroid hormone (at a nonstabilised dosing),
- •colchicine intake, etc.
- •(7) anti-diarrhoeal agent intake during the last month,
- •(8) any subject requiring repeated intake of a drug with a narrow
- •therapeutic margin (for example, digoxin, theophylline, etc.),
- •(9) history of hypersensitivity to diosmectite or its excipients or placebo
- •components,
- •(10) subject likely to require treatment during the study with drugs that
- •are not permitted by the study protocol (for example, antibiotic agent,
- •anti-diarrhoeal agent, antiemetic drug, antispasmodic drug),
- •(11) use of any investigational medication within the last 30 days before
- •entering this study,
- •(12) subject who previously entered in a clinical study within the past 30
- •Other digestive exclusion criteria:
- •(13) History of gastric or intestinal resection, vagotomy,
- •(14) known digestive malabsorption disease, including coeliac disease
- •(15) known lactose intolerance,
- •(16) any suspicion of abdominal surgery need,
- •(17) known inflammatory bowel disease.
- •Other exclusion criteria:
- •(18) Known Human immunodeficiency virus (HIV) positive status,
- •(19) known or suspected immunosuppression,
- •(20) known severe renal or hepatic insufficiency,
- •(21) known endocrine disease or insulin-dependent diabetes,
- 另有 2 项未显示
研究者
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