ArticleFrontiers in pharmacology2024
Validating a composite endpoint for acceptability evaluation of oral drug formulations in the pediatric population: a randomized, open-label, single dose, cross-over study.
Article in Frontiers in pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
4 citing papers in PubMed.
- Article
- How Children with Kawasaki Disease Take Acetylsalicylic Acid Mini-Tablets at Home for the Prescribed Period.Journal of clinical medicine · 2025Article
- Article
- Acceptability of minitablets in soft food. A randomised cross-over study in children.Frontiers in pharmacology · 2025Article
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objective: This study aimed to validate the newly developed composite acceptability endpoint to investigate acceptability of oral pediatric drug formulations that integrates swallowability and palatability assessments. Methods: In this open-label study acceptability of oral formulations was tested in three age groups (1-<6 months, 6-<12 years, and 12-<18 years) with a 2-way cross-over design in children aged 1-<6 months (syrup and mini-tablets), and with an incomplete block design of four sequences with three out of four formulations (syrup, mini-tablets, oblong tablet, and round tablet) each in children aged 6-<18 years. The primary endpoint was acceptability derived from the composite acceptability endpoint. Secondary endpoints were palatability and acceptability derived from swallowability. Results: A total of 320 children were stratified into three age groups (80 children aged 1-<6 months, 120 children aged 6-<12 years, and 120 children aged 12-<18 years). All participants completed the study. Age-specific differences were observed in acceptability derived from the composite acceptability endpoint. Mini-tablets had the highest acceptability in participants aged 1-<6 months and 6-<12 years while the oblong tablet was leading in adolescent participants (12-<18 years). Conclusion: This study demonstrated that the composite acceptability endpoint method integrating both swallowability and palatability assessments is a sensitive method to assess acceptability of drug formulations in children of different age. Clinical Trial Registration: https://drks.de/search/de, identifier DRKS00027948.
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