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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Oral dispersible tablet

• Registration Number: NCT03581799
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Study Timeline

• Study Start: 2018-01-29
• Primary Completion: 2018-03-12
• Study Completion: 2018-03-12
• Study First Submitted: 2018-06-21
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-09
• Study First Posted: 2018-07-10
• Last Update Submitted: 2018-07-10
• Last Update Posted: 2018-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oral dispersible tablet	Oral dispersible tablet	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UKBB; 🇨🇭 Basel, Switzerland