DRKS00030313
Completed
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 sites280 target enrollmentSeptember 28, 2022
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- o specific disease required for study participation, as placebo is taken for investigation of swallowing.
- Sponsor
- Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf
- Enrollment
- 280
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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