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NCT03581799

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

Data source: WHO (Imported from 13.12.2024)
Changed: Dec 20, 2020, 1:05 AM
Disease category:

Health conditions (Data source: WHO)

Healthy

Interventions (Data source: WHO)

Other: Oral dispersible tablet

Inclusion/Exclusion Criteria (Data source: WHO)


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

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT03581799

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT03581799
Further information on trial

Date trial registered

Jun 21, 2018

Incorporation of the first participant

Jan 29, 2018

Recruitment status

Completed

Academic title (Data source: WHO)

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

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).

Phase (Data source: WHO)

N/A

Primary end point (Data source: WHO)

Parent-reported palatability assessed by interview;Child-reported palatability (children aged 6-10 years only) assessed by interview

Secundary end point (Data source: WHO)

Observer-reported palatability assessed by questionnaire;In-situ disintegration behaviour of carrier tablet

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

No

Trial sites

Countries (Data source: WHO)

Switzerland

Contact for further information on the trial

Contact for general information (Data source: WHO)

Julia Bielicki, MD
University of Basel Children's Hospital

Contact for scientific information (Data source: WHO)

Julia Bielicki, MD
University of Basel Children's Hospital

Further trial identification numbers

Secondary ID (Data source: WHO)

2017-01367
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