DRKS00027948已完成未知
Randomized, open, single dose, cross-over study to validate a composite endpoint for acceptability evaluation of oral drug formulations in the paediatric population - Validation of composite endpoint
Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf0 个研究点目标入组 320 人开始时间: 2022年7月21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
- 320
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 Months 至 17 Years（—）
- 性别
- All
入选标准
- •Age: Children aged from 1 - <6 months and from 6 - <18 years
- •Sex: Male and female
- •Health: Participants suffering from illness must be able to swallow the oral formulations and to accept the study procedures. This conclusion is based on medical history, physical examination, and all other appropriate diagnostic procedures.
- •Compliance: Participants and participants’ parents understand and are willing, able, and likely to comply with examination procedures and restrictions.
- •Consent: Participant and/or participant’s parents are capable of understanding the examination procedures, participant obligations as well as risks and benefits of participation in this study and have given written informed consent and assent where possible.
排除标准
- •Disease/Illness: Any impairment of swallowing solids and liquids as a consequence of chronic illness (e.g. cerebral palsy), acute illness (e.g. sepsis, respiratory distress, gastroenteritis, respiratory tract infection), or oral deformation, as assessed by the investigator
- •Intolerance: Lactose intolerance
- •Pre- and Concomitant Medication: Any drug that causes nausea, fatigue, or palsy
- •Intervention: Children in the post-operative period who have yet to commence regular oral feeding
- •Nutrition: Children, who have eaten 1 hour before examination and who afterwards feel sick because of the food
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