<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01682109</url>
  </required_header>
  <id_info>
    <org_study_id>UMCN-AKF 11.05</org_study_id>
    <nct_id>NCT01682109</nct_id>
  </id_info>
  <brief_title>Palatability Testing of a New Paediatric Formulation of Valacyclovir</brief_title>
  <acronym>VALID-0</acronym>
  <official_title>Palatability Testing of a New Paediatric Formulation of Valacyclovir for the Prophylaxis and Treatment of VZV and HSV Infections in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ZonMw: The Netherlands Organisation for Health Research and Development</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Palatability testing of a new paediatric formulation of valacyclovir in children 4-12 years&#xD;
      of age and at least one of their parents. Children will be included, who received&#xD;
      (val)acyclovir prophylaxis in the past, or will probably need it in the future i.e. children&#xD;
      with primary immune deficiency or cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Selection of oral solution with best taste</measure>
    <time_frame>Day 1</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Taste assessment</measure>
    <time_frame>Day 1</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Predictability of palatability preference of the child by parents.</measure>
    <time_frame>Day 1</time_frame>
    <description>To determine whether parents can predict the palatability preference of their child.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Varicella Zoster Virus Infection</condition>
  <condition>Herpes Simplex Virus Infection</condition>
  <arm_group>
    <arm_group_label>new paediatric valacyclovir formulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Newly developed formulation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>reference valacyclovir formulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Formulation derived from FDA label information</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Valacyclovir</intervention_name>
    <arm_group_label>new paediatric valacyclovir formulation</arm_group_label>
    <arm_group_label>reference valacyclovir formulation</arm_group_label>
    <other_name>valacyclovir solution</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is at least 4 years of age.&#xD;
&#xD;
          -  Subject weighs at least 15kg.&#xD;
&#xD;
          -  Subject is capable of performing the taste assessment, according to the investigator's&#xD;
             judgement.&#xD;
&#xD;
          -  The child and parent(s) are willing to participate in the taste assessment.&#xD;
&#xD;
          -  Signed informed consent by the legal guardian for participation of the child and if&#xD;
             the parent also wants to participate: signed informed consent for their own&#xD;
             participation, prior to start of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.&#xD;
&#xD;
          -  Presence of any condition that influences taste sensation (such as upper respiratory&#xD;
             infection, febrile illness within 3 days before the first dose, mucositis or use of&#xD;
             medication that influences taste perception, as described in the label information).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Burger</last_name>
    <role>Principal Investigator</role>
    <affiliation>Radboud University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Radboud University Medical Center</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <results_reference>
    <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.</citation>
    <PMID>28800385</PMID>
  </results_reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>December 4, 2020</last_update_submitted>
  <last_update_submitted_qc>December 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prophylaxis</keyword>
  <keyword>herpes zoster</keyword>
  <keyword>herpes simplex</keyword>
  <keyword>valacyclovir</keyword>
  <keyword>palatability</keyword>
  <keyword>paediatric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
    <mesh_term>Herpes Simplex</mesh_term>
    <mesh_term>Herpes Zoster</mesh_term>
    <mesh_term>Varicella Zoster Virus Infection</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Valacyclovir</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01682109
org study id: UMCN-AKF 11.05
nct id: NCT01682109
lead sponsor: 
collaborator: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Selection of oral solution with best taste
time frame: Day 1
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.
measure: Taste assessment
time frame: Day 1
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.
measure: Predictability of palatability preference of the child by parents.
time frame: Day 1
description: To determine whether parents can predict the palatability preference of their child.
arm group label: new paediatric valacyclovir formulation
arm group type: Experimental
description: Newly developed formulation
arm group label: reference valacyclovir formulation
arm group type: Active Comparator
description: Formulation derived from FDA label information
intervention type: Drug
intervention name: Valacyclovir
arm group label: new paediatric valacyclovir formulation
arm group label: reference valacyclovir formulation
other name: valacyclovir solution
criteria: 
gender: All
minimum age: 4 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: David Burger
role: Principal Investigator
affiliation: Radboud University Medical Center
facility: 
country: Netherlands
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.
PMID: 28800385
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Virus Diseases
mesh term: Herpes Simplex
mesh term: Herpes Zoster
mesh term: Varicella Zoster Virus Infection
mesh term: Valacyclovir