As this is a placebo study, children with any condition can be included.
Conditions
Interventions
Group 1: Low number of mini-tablets (cross-over, 2 mm and 2.5 mm)
Group 2: High number of mini-tablets (cross-over, 2 mm and 2.5 mm)
Sponsors
Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf
Eligibility
Sex/Gender
All
Age
1 Months to 6 Years
Inclusion criteria
Inclusion criteria: Age 1. Children aged from 1 month to 6 years inclusive Sex 2. Male and female Health 3. Based on medical history, physical examination, and all other appropriate diagnostic procedures they are able to swallow. Participants suffering from illness must be able to swallow the mini-tablets and to accept the study procedures. This conclusion is based on medical history, physical examination, and all other appropriate diagnostic procedures as assessed by the Principal Investigator, Principal Investigator’s deputies, or sub-investigators. Compliance 4. Participants and participants’ parents understand and are willing, able, and likely to comply with examination procedures and restrictions. Consent 5. Participant and/or participant’s parents or legal guardians are capable of understanding the examination procedures, participant obligations as well as risks and benefits of participation in this study and have given written informed consent and assent where possible.
Exclusion criteria
Exclusion criteria: Disease/Illness 1. 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. Intolerance 2. Lactose-Intolerance Pre- and Concomitant Medication 3. Any drug that causes nausea, fatigue, or palsy Intervention 4. Children in the post-operative period who have yet to commence regular oral feeding Nutrition 5. Children, who have eaten one hour before examination and who afterwards feel sick because of the food
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to investigate the acceptability of a high quantity of 2 mm diameter coated mini-tablets compared to a low quantity of 2.5 mm diameter coated mini-tablets of in children aged from 1 month to 6 years accounting for the requirement of weight based dosing in different age groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To compare the swallowability of 2 mm and 2.5 mm mini-tablets in children aged from 1 month to 6 years - To compare the palatability of 2 mm and 2.5 mm mini-tablets in children aged from 1 month to 6 years - To identify any possible problem that could occur during swallowing - To identify the percentage of children who inhaled or coughed during ingestion of any of the oral formulations - To investigate the safety of the drug-free mini-tablets | — |
Countries
Germany
Contacts
Public ContactViviane Klingmann
Universitätsklinik Düsseldorf, Heinrich-Heine Universität Düsseldorf, Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie
Outcome results
None listed