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

NCT03581799 | Completed

• 1 other identifier: 2017-01367
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Child

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Observer-reported palatability assessed by questionnaire

  Day 1

• In-situ disintegration behaviour of carrier tablet

  Day 1

Study Arms (1)

Oral dispersible tablet

OTHER

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

Interventions

Oral dispersible tablet 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).

Also known as: Oral dispersible tablet (carrier tablet - no active pharmacological ingredient)

Oral dispersible tablet

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

UKBB

Basel, Switzerland

Location

Study Officials

• Julia Bielicki, MD

  University of Basel Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 10, 2018
• Study Start: January 29, 2018
• Primary Completion: March 12, 2018
• Study Completion: March 12, 2018
• Last Updated: July 12, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)