Acceptability and capability to swallow multiple minitablets in comparison to glucose syrup
Conditions
Interventions
Group 1: Minitablets: 16 up to 28 granules depending on age group
coated placebo minitablets
Group 2: Glucose-syrup: 3.0 up to 6.0 ml syrup depending on age group. Placebo.
Sponsors
Novartis Pharma Arzneimittel GmbH
Eligibility
Sex/Gender
All
Age
1 Years to 5 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent must be obtained before any assessment is performed 2. Informed consent provided by parents and assent provided by the child where age appropriate 3. Male or female, 1 to < 6 years of age 4. Participant and/or participant's parents are capable of understanding the examination procedures, participant obligations, as well as risks of participation in this study 5. Children who are patients (inpatient, outpatient) for any medical condition at the study site. They have to be in generally good medical condition and able to comply with the study requirements.
Exclusion criteria
Exclusion criteria: 1.Any impairment of swallowing either solids or glucose-syrup as a consequence of: •Chronic illness (e.g. cerebral palsy) •Acute illness (e.g. gastroenteritis, respiratory tract infection) •Oral deformation •Lactose-Intolerance 2.Pre- and concomitant medication that causes nausea, fatigue or palsy. 3.For children having had any surgical intervention, the study assessments may only occur following return to regular diet 4.Children, who have eaten one hour before study assessments and/or who after the meal feels sick.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the acceptability of an age-adapted predefined number of coated granules administered at once in comparison to an age-adapted amount of glucose syrup in children from 1 year to < 6 years (deglutition evaluation). Evaluation criteria for the outcome of mini-tablets and syrup administration have been predefined. There is a ranking into 5 groups, e.g. 1 = completely swallowed, 5 = refused to take. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the average number of accepted coated granules by age group (deglutition evaluation). To investigate the safety and tolerabilits of the oral placebo formulations (results from physical examination, adverse events) To identify reasons why parents are not willing to consent for their children to participate in this study (screen failure evaluation) | — |
Countries
Germany
Contacts
Public ContactHans Martin Bosse
Universitätsklinikum Düsseldorf
Outcome results
None listed