CAMEO

• Research type

  Research Study

• Full title

  A study to assess children’s acceptability of placebo minitablets when mixed with soft food.

• IRAS ID

  324507

• Contact name

  Louise Bracken

• Contact email

  Louise.Bracken@alderhey.nhs.uk

• Sponsor organisation

  Alder Hey Children's NHS Foundation Trust

• Duration of Study in the UK

  0 years, 10 months, 5 days

• Research summary

  Traditionally, liquid medicines have been considered the most acceptable oral formulation for use in children, as they are easy to swallow and required 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 patient compliance and adherence to oral treatment regimens.

  Research studies have shown that many children do not like the taste of oral liquid medicines. To solve this problem, minitablets could be a suitable alternative, particularly for young children under 4 years of age, who may be unable to swallow conventional sized tablets.

  Recently, the use of oral solid formulations for children such as minitablets is gaining increasing support from regulatory authorities; based on their better stability profile, ease of transport, lower number of (potentially ‘non-child friendly’) ingredients compared to oral liquid medicines. Such formulations also allow the use of alternative administration methods such as mixing with food/drink to aid administration for those with swallowing difficulties such as very young children, or even the elderly.

  This study will investigate whether 2.3mm sized placebo minitablets are acceptable to children aged 6 months to 7 years. It will determine if participants can swallow a set number of minitablets, based on their age, when mixed with a soft food of their choice (apple sauce/smooth yoghurt).

  It will also investigate if the amount of soft food has any effect on the suitability of minitablets as a dosage form for children. Participants (1 year and over) will attempt to swallow two samples of minitablets, mixed with two different volumes (high and low amount) of a soft food of their choice. We want to understand which of the samples, if any, children find more acceptable and the easiest to swallow.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  23/SC/0238

• Date of REC Opinion

  7 Jul 2023

• REC opinion

  Favourable Opinion