No specific medical condition is required to participate in the study, as a placebo will be administered to assess the acceptability of the capsules.
Conditions
Interventions
Group 1: Sequence A:
1 Capsule size 0, single dose administration:
Evaluation of swallowability, palatabilty and ease of administration
2 Capsules size 1, single dose administration:
Evaluation of
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: -Age: Adolescents aged 12 - <18 years -Sex: Male or female -Disease and severity: Acutely or chronically ill adolescents -Previous therapy: Not applicable - Other specific requirements: Willingness and capability of participants to read and understand German language and comply with examination procedures -Informed consent: Written informed consent from both parents or legal representatives, and Assent where possible
Exclusion criteria
Exclusion criteria: -Disease/illness: Any impairment of swallowing solids 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, patients on intensive care unit wards - Intolerance: History of hypersensitivity to any of the ingredients present in the capsules -Pre- and concomitant medication: Any drug that causes nausea, fatigue, or palsy -Intervention: Adolescents in the post-operative period who have yet to commence regular oral feeding -Nutrition: Adolescents who have eaten 1 h before examination and who afterwards feel sick because of the food
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acceptability derived as composite endpoint from palatability (as rated by the participant) and swallowability (as rated by the investigator) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Ease of administration of each capsule regimen assessed by a 10-point scoring scale - Preference concerning the two capsule regimens - Swallowing problems | — |
Countries
Germany
Contacts
Public ContactViviane Klingmann
Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie
Outcome results
None listed