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Completed

NCT Number: NCT03581799

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

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.

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Key information

Conditions

Healthy

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UKBB

Basel, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Oral dispersible tablet (carrier tablet - no active pharmacological ingredient)

Primary outcomes

  1. Parent-reported palatability assessed by interview

    Time frame: Day 1

    5-point Likert scale, 1 "completely acceptable" to 5 "completely unacceptable"

  2. Child-reported palatability (children aged 6-10 years only) assessed by interview

    Time frame: Day 1

    6-point Facial Hedonic Scale (0 "no discomfort on taking tablet" to 10 "maximum discomfort on taking tablet"

Secondary outcomes

  1. Observer-reported palatability assessed by questionnaire

    Time frame: Day 1

    4-point Likert scale (0 "child refuses to take tablet" to 4 "child proactively takes tablet")

  2. In-situ disintegration behaviour of carrier tablet

    Time frame: Day 1

    Staff-observed disintegration of the tablet at 20, 40 and 60 seconds of placement

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 10, 2018
Registry last updated
Jul 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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