Take it EZ
Research type
Research Study
Full title
A study to assess the swallowability of placebo tablets (with or without film coating systems) in children and young people.
IRAS ID
281611
Contact name
Jennifer Duncan
Contact email
Sponsor organisation
Alder Hey Children's NHS Foundation Trust
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Developing better medicines for children is currently a “hot” topic in the pharmaceutical industry as there are very few age-appropriate and acceptable medicines for this population.
Liquid medicines have been traditionally considered the most commonly used oral formulation for children, as they are easy to swallow by the patient and doses can be measured at the point of use. However, the taste of a paediatric medicine is one of the most important formulation factors to be considered as it has the potential to influence adherence and compliance to treatment regimens. Research studies have shown that many children do not like the taste of oral liquid medicines. To solve this problem, tablets could be a better option for children. More recently, oral solid formulations such as tablets are gaining support from regulatory authorities; based on their better stability profile, lower number of (potentially non-approved) ingredients and their suitability for taste-masking and more appealing appearance via film coating systems.
We want to improve medicines available for children. This study will investigate the ability of children and young people (CYP) to swallow 8mm sized placebo tablets and determine if a tablet coating(s) has any effect on this. Participants will be asked to attempt to swallow three placebo tablets (these samples do not contain any medicine) of identical size/shape. One tablet will be uncoated and the other two tablets will have a different film coating system (one becomes slippery in the mouth) applied to each of them. We want to understand which of the tablets, if any; children find the easiest to swallow.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
20/YH/0238
Date of REC Opinion
16 Sep 2020
REC opinion
Favourable Opinion