Healthy
Conditions
Keywords
Child
Brief summary
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.
Detailed description
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.
Interventions
OTHEROral dispersible tablet
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).
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 2 and 10 years * Attending study site as an outpatient during the study period. * Informed consent form for study participation signed by legal guardian * Verbal assent to participation from child
Exclusion criteria
* Wearing dental braces * Injuries or inflammatory disease affecting the oral cavity or throat * Dysphagia * Olfactory impairment * Known renal impairment * Known hypercalcaemia, * Any known allergy against medications * Ongoing antibiotic treatment at the time of the study * Moderate-severe developmental delay as reported by the parents * Parents/legal guardians are unlikely to reliably complete structured questionnaire because of significant language barriers * Participation in another study with investigational drug within the 30 days preceding and during the present study, * Previous enrolment into the current study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parent-reported palatability assessed by interview | Day 1 | 5-point Likert scale, 1 completely acceptable to 5 completely unacceptable |
| Child-reported palatability (children aged 6-10 years only) assessed by interview | Day 1 | 6-point Facial Hedonic Scale (0 no discomfort on taking tablet to 10 maximum discomfort on taking tablet |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observer-reported palatability assessed by questionnaire | Day 1 | 4-point Likert scale (0 child refuses to take tablet to 4 child proactively takes tablet) |
| In-situ disintegration behaviour of carrier tablet | Day 1 | Staff-observed disintegration of the tablet at 20, 40 and 60 seconds of placement |
Countries
Switzerland
Outcome results
None listed