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

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ClinicalTrials.gov Identifier: NCT03581799
Recruitment Status : Completed
First Posted : July 10, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Other: Oral dispersible tablet Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Investigation of Palatability of an Oral Dispersible Tablet (ODT) Formulation in Children Aged 2 to 10 Years
Actual Study Start Date : January 29, 2018
Actual Primary Completion Date : March 12, 2018
Actual Study Completion Date : March 12, 2018
Arms and Interventions
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Arm Intervention/treatment
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 Name: Oral dispersible tablet (carrier tablet - no active pharmacological ingredient)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03581799


Locations
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Switzerland
UKBB
Basel, Switzerland
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Julia Bielicki, MD University of Basel Children's Hospital
More Information
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03581799    
Other Study ID Numbers: 2017-01367
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Basel, Switzerland:
Child