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

University Hospital Basel

Status: Completed

Conditions: Healthy

Treatments: Other: Oral dispersible tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03581799

2017-01367

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Oral dispersible tablet

Other group

Description:

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).

Treatment:

Other: Oral dispersible tablet