Randomized, Cross-over Physiological Examination of Acceptability and Capability to Swallow Three Oral Placebo Formulations for Children of Six Different Age Groups

Phase 1

• Conditions: Children not suffering from a special disease.

• Registration Number: DRKS00000432
• Lead Sponsor: niversitätsklinik DüsseldorfKlinik für Allgemeine Pädiatrie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-01
• Study Completion: 2011-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

1. Age: Children aged from 0.5 to 5 years inclusive
2. Sex: Male and female
3. Recruiting: Recruiting will take place in the Paediatric Clinic of University Hospital Düsseldorf
(inhouse and outpatient).
4. Health: Participants suffering from illness must be able to swallow in the opinion of the
Principal Investigator based on medical history, physical examination and all other appropriate
diagnostic procedures.
5. Compliance: Participant and participant's parents understand and are willing, able and like to
comply with examination procedures and restrictions.
6. 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
physiological examination and have given written informed consent.

Exclusion Criteria

1. Disease/Illness: Any impairment of swallowing either solids or glucose-syrup as a consequence
of
a)chronic illness (e.g. cerebral palsy)
b)acute illness (e.g. gastroenteritis, respiratory tract infection)
c)oral deformation
2. Intolerance: Lactose-Intolerance
3. Pre- and Concomitant Medication: Any drug that causes nausea, fatigue or palsy.
4. Intervention: No examination shortly after surgical intervention until child is allowed to eat and
capable to follow the physiological examination-related instructions.
5. Nutrition: Children, who have eaten one hour before examination and who afterwards feel sick

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To prove that the acceptability of the uncoated minitablet is superior to the acceptability of the syrup in the group of children between 0.5 and 5 years inclusive.<br><br>These parameters are collected right after oral application by oral inspection.