DRKS00030313已完成未知
Pilot study - Evaluation and correlation of different measurement methods for tablet swallowability and palatability in test persons aged = 12 years for the development of a standardised procedure - EkoMeSS
Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf0 个研究点目标入组 280 人开始时间: 2022年9月28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
- 280
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
- 12 Years 至 one（—）
- 性别
- All
入选标准
- •Five different age groups or groups of test persons are included
- •- 12 - 17 years
- •- 18 - 30 years
- •- 31 - 65 years healthy tablet inexperienced (= 1 tablet per week)
- •- 31 - 65 years multimorbid tablet-experienced (daily intake of = 3 tablets)
- •- 66 years and older
- •Half female and half male
- •All participants will be screened using a standardised adult examination form to ensure that their ability to swallow is not impaired and that they are actually able to swallow.
- •4. Compliance
- •Subjects and, if applicable, guardians understand and are willing and able to comply with the screening procedures and restrictions.
- •5. Consent
- •The subject(s) and/or legal guardian(s) are able to understand the study procedures, obligations, risks and benefits of participation in this study and have provided written informed consent. In the adolescent group, the legal guardians have also given their informed consent.
排除标准
- •1. Diseases
- •Diseases that may involve a diagnosable impairment of swallowing solids or solid oral dosage forms.
- •a) CNS disease (e.g. dementia, Parkinson's disease)
- •b) acute illness (e.g. sepsis, respiratory distress, gastroenteritis, respiratory infection)
- •c) Dysphagia / Presbyphagia
- •2. Intolerance
- •Lactose intolerance
- •3. Chronic or acute drug intake
- •Any drug that can cause nausea, fatigue, dry mouth or paralysis as a side effect.
- •4. Interventions
- •Invasive therapeutic interventions have been performed on the subjects prior to the study or are planned after the study.
- •Subjects have eaten food at least 1 hour before the study and experience nausea. The intake of fluids is permitted.
- •6. Pacemaker
- •Subjects wearing a pacemaker are excluded from the study.
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