DRKS00010395已完成未知
Randomized, open-label, cross-over study to investigate small children's acceptability and capability to swallow multiple coated placebo granules
ovartis Pharma Arzneimittel GmbH0 个研究点目标入组 50 人开始时间: 2016年4月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 1 Years 至 5 Years（—）
- 性别
- All
入选标准
- •1. Written informed consent must be obtained before any assessment is performed
- •2. Informed consent provided by parents and assent provided by the child where age appropriate
- •3. Male or female, 1 to < 6 years of age
- •4. Participant and/or participant's parents are capable of understanding the examination procedures, participant obligations, as well as risks of participation in this study
- •5. Children who are patients (inpatient, outpatient) for any medical condition at the study site. They have to be in generally good medical condition and able to comply with the study requirements.
排除标准
- •1.Any impairment of swallowing either solids or glucose-syrup as a consequence of:
- •Chronic illness (e.g. cerebral palsy)
- •Acute illness (e.g. gastroenteritis, respiratory tract infection)
- •Oral deformation
- •Lactose-Intolerance
- •2.Pre- and concomitant medication that causes nausea, fatigue or palsy.
- •3.For children having had any surgical intervention, the study assessments may only occur following return to regular diet
- •4.Children, who have eaten one hour before study assessments and/or who after the meal feels sick.
研究者
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