Evidence map›Paper›PMID 28800385›Full record

Trial reportBritish journal of clinical pharmacology2017

In vivo and in vitro palatability testing of a new paediatric formulation of valaciclovir.

Diane E T Bastiaans, Laura I Immohr, Gertrude G Zeinstra, Riet Strik-Albers, Miriam Pein-Hackelbusch, Michiel van der Flier, Anton F J de Haan, Jaap Jan Boelens, Arjan C Lankester, David M Burger and 1 more

Registry-linked trialOpen access · hybridAbstract readComparative StudyEquivalence TrialMulticenter Study
In one paragraph

Trial report in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01682109 (Palatability Testing of a New Paediatric Formulation of Valacyclovir for the Prophylaxis and Treatment of VZV and HSV Infections in Children), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.0field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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.

NCT01682109 phase4completednot on this map

Palatability Testing of a New Paediatric Formulation of Valacyclovir for the Prophylaxis and Treatment of VZV and HSV Infections in Children

TypeinterventionalSponsorRadboud University Medical CenterRan2012 to 2016Enrolled41ConditionsVaricella Zoster Virus Infection, Herpes Simplex Virus InfectionArmsValacyclovir
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
  6. Examining a New Scale for Evaluating Taste in Children (TASTY).The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2020
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 4 countries.

Diane E T BastiaansDepartment of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID 0000-0001-8680-6109
Laura I ImmohrInstitute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University, Düsseldorf, Germany.
Gertrude G ZeinstraConsumer Science & Health, Wageningen UR Food & Biobased Research, Wageningen, The Netherlands.
Riet Strik-AlbersDepartment of Paediatrics and Radboud Institute Molecular Life Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.
Miriam Pein-HackelbuschLife Science Technologies, University of Applied Sciences Ostwestfalen-Lippe, Detmold, Germany.
Michiel van der FlierDepartment of Paediatrics and Radboud Institute Molecular Life Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.
Anton F J de HaanDepartment for Health Evidence, Radboud University Medical Center, Nijmegen, The Netherlands.
Jaap Jan BoelensDepartment of Paediatrics, Paediatric Blood and Marrow Transplantation Program, University Medical Center, Utrecht, The Netherlands.
Arjan C LankesterDepartment of Paediatrics, Leiden University Medical Center, Leiden, The Netherlands.
David M BurgerDepartment of Pharmacy, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID 0000-0001-7279-2818
Adilia WarrisInstitute of Medical Sciences, Infection, Immunity and Inflammation Research Group; Aberdeen Fungal Group, University of Aberdeen, UK.
Radboud University Nijmegen · NLChemisches und Veterinäruntersuchungsamt Ostwestfalen-Lippe · DEHeinrich Heine University Düsseldorf · DELeiden University Medical Center · NLUniversity Medical Center Utrecht · NLUniversity of Aberdeen · GBWageningen University & Research · NL

Funding

Medical Research Council MR/N006364/1
6 · The paper itself

Abstract

aimsThe palatability of a new paediatric formulation of valaciclovir was assessed in children and their parents: non-inferiority of the new paediatric formulation (test formulation) compared to the reference formulation was investigated.

methodsIn vivo palatability testing was performed in a randomized, two-period, multicentre, cross-over study. Children and their parents scored the liking of the new paediatric valaciclovir formulation and the reference formulation on a 100 mm visual analogue scale (VAS). To support formulation development and palatability testing, electronic tongue measurements were applied.

resultsThe electronic tongue measurement indicated taste-masking capabilities for three different formulations in the developmental phase. A glycerol-based formulation was further tested and compared to the reference formulation prepared out of crushed and suspended tablets. The mean difference (95% CI) in VAS scores between both formulations, as indicated by the children (n = 20), was 2.4 (-8.5, 13) mm, in favour of the new paediatric valaciclovir formulation. The mean (95% CI) difference in VAS scores indicated by the parents (n = 20) was -0.9 (-12, 9.8) mm.

conclusionThe palatability of the new paediatric valaciclovir formulation was considered non-inferior to the reference formulation prepared out of crushed tablets. We were able to optimize the study design and number of children to be included in the palatability testing by using electronic tongue measurements.

Indexed as

Electronic NoseTasteAcyclovirAdministration, OralAge FactorsAntiviral AgentsChildChild, PreschoolCross-Over StudiesDrug CompoundingHumansNetherlandsPatient SatisfactionPerceptual MaskingPharmaceutical SolutionsTabletsAcyclovirAntiviral AgentsPharmaceutical SolutionsTabletsValacyclovirValinedrug developmentinfectious diseasespaediatricspharmacotherapyquality use of medicines

Identifiers

PMID28800385
PMCPMC5698570
OpenAlexW2744321363

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.