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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Radboud University
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01682109
First received: September 5, 2012
Last updated: January 25, 2016
Last verified: January 2016
  Purpose
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 Intervention Phase
Varicella Zoster Virus Infection
Herpes Simplex Virus Infection
Drug: Valacyclovir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Selection of oral solution with best taste [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    To determine whether parents can predict the palatability preference of their child.


Estimated Enrollment: 70
Study Start Date: September 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682109

Contacts
Contact: Diane Bastiaans +31243616405 diane.bastiaans@radboudumc.nl
Contact: David Burger +31243616405 david.burger@radboudumc.nl

Locations
Netherlands
Radboud University Medical Center Recruiting
Nijmegen, Netherlands
Contact: Diane Bastiaans    +31243616405    diane.bastiaans@radboudumc.nl   
Contact: Angela Colbers    +31243616405    angela.colbers@radboudumc.nl   
Principal Investigator: David Burger         
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
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 
Study First Received: September 5, 2012
Last Updated: January 25, 2016
Health Authority: Netherlands: Ministry of Health, Welfare and Sport

Keywords provided by Radboud University:
prophylaxis
herpes zoster
herpes simplex
valacyclovir
palatability
paediatric

Additional relevant MeSH terms:
Herpes Simplex
Communicable Diseases
Herpes Zoster
Infection
Virus Diseases
DNA Virus Infections
Herpesviridae Infections
Skin Diseases
Skin Diseases, Infectious
Skin Diseases, Viral
Acyclovir
Valacyclovir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 04, 2016