EUCTR2017-000278-13-FR进行中（未招募）1 期
Palatability testing in children of a new paediatric formulation of Racecadotril as oral suspension strawberry-flavored administered via an oral graduated syringe compared to the current formulation (apricot-flavored oral powder in sachet to be diluted).
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
- 40
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
- •-Children, boys and girls, aged from 7 to 12 years in good health
- •-Capable of performing the taste assessment, according to the investigator’s judgment
- •-Willing to participate to the taste assessment and to give his (her) assent in writing after a process of appropriate information according to his (her) capacity of understanding
- •-The informed consent of the parent or legal representative should be obtained for the participation of his(her) child
- •-Parent or legal representative, in good health, capable of performing the taste assessment and having signed the specific informed consent for his(her) own participation
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •For the 2 populations, adult and children
- •-Previous history of sensitivity or allergy to the active substance or any medicinal products or excipients
- •-Subjects with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption syndrome or saccharase-isomaltase deficiency
- •-Presence of any condition that could influence taste sensations within the 5 days before the test (upper respiratory infection, fever, buccal mucositis, aphtous ulcers)
- •-Intake within the 4 hours preceeding the test of substances that could interfere with taste sensation (highly spiced meals, mint or menthol – based products, chewing-gums)
- •Specific for children
- •-Child incapable, according the investigator’s opinion, to perform the test as planned in the protocol (to keep the product in the mouth without swallowing and then spit it out) and/or to express his (her) own taste impression
- •-Child has not given his (her) assent to participate or informed consent was not obtained from the parent
研究者
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