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

NCT ID: NCT03581799

Last Updated: 2018-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-29
• Study Completion Date: 2018-03-12

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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).

Group Type: OTHER

Oral dispersible tablet

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

Other Intervention Names

Oral dispersible tablet (carrier tablet - no active pharmacological ingredient)

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia Bielicki, MD

Role: PRINCIPAL_INVESTIGATOR

University of Basel Children's Hospital

Locations

UKBB

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

2017-01367

Identifier Type: -

Identifier Source: org_study_id