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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Oral dispersible tablet

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland
    • UKBB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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).	Other: Oral 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).; Other Names: Oral dispersible tablet (carrier tablet - no active pharmacological ingredient)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Julia Bielicki, MD, University of Basel Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2018
• Primary Completion (Actual): March 12, 2018
• Study Completion (Actual): March 12, 2018

Study Registration Dates

• First Submitted: June 21, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (Actual): July 10, 2018

Study Record Updates

• Last Update Posted (Actual): July 12, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Child
• Other Study ID Numbers: 2017-01367

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No