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

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ClinicalTrials.gov Identifier: NCT01682109
Recruitment Status : Completed
First Posted : September 10, 2012
Last Update Posted : May 25, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Varicella Zoster Virus Infection Herpes Simplex Virus Infection Drug: Valacyclovir Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Palatability Testing of a New Paediatric Formulation of Valacyclovir for the Prophylaxis and Treatment of VZV and HSV Infections in Children
Study Start Date : September 2012
Primary Completion Date : March 2016
Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: new paediatric valacyclovir formulation
Newly developed formulation
Drug: Valacyclovir
Other Name: valacyclovir solution
Active Comparator: reference valacyclovir formulation
Formulation derived from FDA label information
Drug: Valacyclovir
Other Name: valacyclovir solution

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Eligibility Criteria

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01682109

Radboud University Medical Center
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Principal Investigator: David Burger Radboud University
More Information

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01682109     History of Changes
Other Study ID Numbers: UMCN-AKF 11.05
First Posted: September 10, 2012    Key Record Dates
Last Update Posted: May 25, 2016
Last Verified: January 2016

Keywords provided by Radboud University:
herpes zoster
herpes simplex

Additional relevant MeSH terms:
Communicable Diseases
Virus Diseases
Herpes Simplex
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Antiviral Agents
Anti-Infective Agents