Healthy Clinical Trial
Official title:
Investigation of Palatability of an Oral Dispersible Tablet (ODT) Formulation in Children Aged 2 to 10 Years
Verified date | July 2018 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | UKBB | Basel |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland |
Switzerland,
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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