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Clinical Trials/DRKS00030313
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.

Registry
who.int
Start Date
September 28, 2022
End Date
March 9, 2023
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf

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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