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Palatability Testing of a New Paediatric Formulation of Valacyclovir (VALID-0)

Primary Purpose

Varicella Zoster Virus Infection, Herpes Simplex Virus Infection

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Valacyclovir
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Varicella Zoster Virus Infection focused on measuring prophylaxis, herpes zoster, herpes simplex, valacyclovir, palatability, paediatric

Eligibility Criteria

4 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Sites / Locations

  • Radboud University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

new paediatric valacyclovir formulation

reference valacyclovir formulation

Arm Description

Newly developed formulation

Formulation derived from FDA label information

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Taste assessment
Children will score the taste of 3 different oral valacyclovir solutions. A 100 mm facial hedonic scale will be employed to indicate the palatability of each formulation.
Predictability of palatability preference of the child by parents.
To determine whether parents can predict the palatability preference of their child.

Full Information

First Posted
September 5, 2012
Last Updated
December 4, 2020
Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01682109
Brief Title
Palatability Testing of a New Paediatric Formulation of Valacyclovir
Acronym
VALID-0
Official Title
Palatability Testing of a New Paediatric Formulation of Valacyclovir for the Prophylaxis and Treatment of VZV and HSV Infections in Children
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicella Zoster Virus Infection, Herpes Simplex Virus Infection
Keywords
prophylaxis, herpes zoster, herpes simplex, valacyclovir, palatability, paediatric

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
new paediatric valacyclovir formulation
Arm Type
Experimental
Arm Description
Newly developed formulation
Arm Title
reference valacyclovir formulation
Arm Type
Active Comparator
Arm Description
Formulation derived from FDA label information
Intervention Type
Drug
Intervention Name(s)
Valacyclovir
Other Intervention Name(s)
valacyclovir solution
Primary Outcome Measure Information:
Title
Selection of oral solution with best taste
Description
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.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Taste assessment
Description
Children will score the taste of 3 different oral valacyclovir solutions. A 100 mm facial hedonic scale will be employed to indicate the palatability of each formulation.
Time Frame
Day 1
Title
Predictability of palatability preference of the child by parents.
Description
To determine whether parents can predict the palatability preference of their child.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Burger
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radboud University Medical Center
City
Nijmegen
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
28800385
Citation
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.
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Palatability Testing of a New Paediatric Formulation of Valacyclovir

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