Palatability Testing of a New Paediatric Formulation of Valacyclovir
NCT ID: NCT01682109
Last Updated: 2020-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
41 participants
INTERVENTIONAL
2012-09-30
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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new paediatric valacyclovir formulation
Newly developed formulation
Valacyclovir
reference valacyclovir formulation
Formulation derived from FDA label information
Valacyclovir
Interventions
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Valacyclovir
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject weighs at least 15kg.
* Subject is capable of performing the taste assessment, according to the investigator's judgement.
* The child and parent(s) are willing to participate in the taste assessment.
* Signed informed consent by the legal guardian for participation of the child and if the parent also wants to participate: signed informed consent for their own participation, prior to start of the study.
Exclusion Criteria
* Presence of any condition that influences taste sensation (such as upper respiratory infection, febrile illness within 3 days before the first dose, mucositis or use of medication that influences taste perception, as described in the label information).
4 Years
ALL
Yes
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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David Burger
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Radboud University Medical Center
Nijmegen, , Netherlands
Countries
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References
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Bastiaans DET, Immohr LI, Zeinstra GG, Strik-Albers R, Pein-Hackelbusch M, van der Flier M, de Haan AFJ, Boelens JJ, Lankester AC, Burger DM, Warris A. In vivo and in vitro palatability testing of a new paediatric formulation of valaciclovir. Br J Clin Pharmacol. 2017 Dec;83(12):2789-2797. doi: 10.1111/bcp.13396. Epub 2017 Sep 20.
Other Identifiers
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UMCN-AKF 11.05
Identifier Type: -
Identifier Source: org_study_id