Palatability Testing of a New Paediatric Formulation of Valacyclovir
VALID-0
1 other identifier
interventional
41
1 country
1
Brief Summary
Palatability testing of a new paediatric formulation of valacyclovir in children 4-12 years of age and at least one of their parents. Children will be included, who received (val)acyclovir prophylaxis in the past, or will probably need it in the future i.e. children with primary immune deficiency or cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2012
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 5, 2012
CompletedFirst Posted
Study publicly available on registry
September 10, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedDecember 7, 2020
December 1, 2020
3.5 years
September 5, 2012
December 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Selection of oral solution with best taste
Patients (children) will assess the taste of 3 different oral solutions. A questionnaire has to be completed to order the palatability of the three formulations.
Day 1
Secondary Outcomes (2)
Taste assessment
Day 1
Predictability of palatability preference of the child by parents.
Day 1
Study Arms (2)
new paediatric valacyclovir formulation
EXPERIMENTALNewly developed formulation
reference valacyclovir formulation
ACTIVE COMPARATORFormulation derived from FDA label information
Interventions
Eligibility Criteria
You may qualify if:
- Subject is at least 4 years of age.
- 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.
You may not qualify if:
- Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radboud University Medical Center
Nijmegen, Netherlands
Related Publications (1)
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.
PMID: 28800385RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Burger
Radboud University Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2012
First Posted
September 10, 2012
Study Start
September 1, 2012
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
December 7, 2020
Record last verified: 2020-12