Skip to main content
OpenTrials
Completed

NCT Number: NCT01682109

Palatability Testing of a New Paediatric Formulation of Valacyclovir

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Varicella Zoster Virus Infection DNA Virus Infections Herpes Simplex Herpes Simplex Virus Infection Herpes Zoster Herpesviridae Infections Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Virus Diseases

Age range

4 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Radboud University Medical Center

Nijmegen, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Valacyclovir

Drug

Other names: valacyclovir solution

Primary outcomes

  1. Selection of oral solution with best taste

    Time frame: Day 1

    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 outcomes

  1. Taste assessment

    Time frame: Day 1

    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.

  2. Predictability of palatability preference of the child by parents.

    Time frame: Day 1

    To determine whether parents can predict the palatability preference of their child.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

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

Acronym: VALID-0

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 10, 2012
Registry last updated
Dec 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.