EUCTR2015-001138-10-CZ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
适应症
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 symptoms*
- •- having started within 48 hours before Visit 1 (first study drug intake time).
- •(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; 131:1480–91.
- •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 days.
- •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) uncontrolled diabetes of all types and non insulin dependant diabetes during first 6 months of medical treatment and other known endocrine disease,
- •(22) history of, or known current, problems with alcohol abuse and/or known drug addiction (cocaine, heroin, hashish…),
- •(23) previous enrolment in this study,
- •(24) any mental condition rendering the subject unable to understand the nature,
研究者
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