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This is a cross-sectional study investigating the palatability of an oral dispersible tablet with no pharmacologically active agent (carrier tablet) in children without underlying acute or chronic disease aged 2 to 10 years of age.
Oral dispersible tablets (ODTs) are a monolithic solid formulation potentially appropriate for a wide range of paediatric age groups. They also have a number of advantages over more frequently used formulation types, such as suspensions. Currently few Commercial products are available as ODTs for administration to children. Investigators aimed to investigate the palatability of an oral dispersible tablet with no pharmacologically active agent (carrier tablet) by assessing overall parent-reported, observer-reported and, where appropriate, child-reported acceptance of the formulation. In addition, investigators assessed the in situ disintegration behaviour of the carrier tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral dispersible tablet | Other | 5 mm calcium carbonate based ODT will be administered by placing it in the buccal pouch (children aged 2-5 years) or on the tongue (children aged 6-10 years). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral dispersible tablet | Other | Administration of a 5 mm calcium carbonate based ODT placed in the buccal pouch (children aged 2-5 years) or on the tongue (children aged 6-10 years). |
| Measure | Description | Time Frame |
|---|---|---|
| Parent-reported palatability assessed by interview | 5-point Likert scale, 1 "completely acceptable" to 5 "completely unacceptable" | Day 1 |
| Child-reported palatability (children aged 6-10 years only) assessed by interview | 6-point Facial Hedonic Scale (0 "no discomfort on taking tablet" to 10 "maximum discomfort on taking tablet" | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Observer-reported palatability assessed by questionnaire | 4-point Likert scale (0 "child refuses to take tablet" to 4 "child proactively takes tablet") | Day 1 |
| In-situ disintegration behaviour of carrier tablet |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Bielicki, MD | University of Basel Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UKBB | Basel | Switzerland |
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Staff-observed disintegration of the tablet at 20, 40 and 60 seconds of placement
| Day 1 |