Palatability of an Oral Dispersible Tablet (ODT) Formulation in Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Investigation of Palatability of an Oral Dispersible Tablet (ODT) Formulation in Children Aged 2 to 10 Years

Conditions
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Healthy

Intervention / Treatment
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* Other: Oral dispersible tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Oral dispersible tablet<br>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). | Other: Oral dispersible tablet<br>* 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).<br>* Other names: Oral dispersible tablet (carrier tablet - no active pharmacological ingredient);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Staff-observed disintegration of the tablet at 20, 40 and 60 seconds of placement | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child