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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03581799
Other study ID # 2017-01367
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 29, 2018
Est. completion date March 12, 2018

Study information

Verified date July 2018
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date March 12, 2018
Est. primary completion date March 12, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 10 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
Switzerland UKBB Basel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Parent-reported palatability assessed by interview 5-point Likert scale, 1 "completely acceptable" to 5 "completely unacceptable" Day 1
Primary 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 Observer-reported palatability assessed by questionnaire 4-point Likert scale (0 "child refuses to take tablet" to 4 "child proactively takes tablet") Day 1
Secondary In-situ disintegration behaviour of carrier tablet Staff-observed disintegration of the tablet at 20, 40 and 60 seconds of placement Day 1
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