Palatability Testing of a New Paediatric Formulation of Valacyclovir - VALID 0 (VALID0)

This study has suspended participant recruitment.
(oral liquid not available)
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: August 28, 2013
Last verified: August 2013
  Purpose

Palatability testing of 3 different formulations of a newly developed paediatric valacyclovir oral solution 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: Single Blind (Subject)
Official Title: Palatability Testing of a New Paediatric Formulation of Valacyclovir for the Prophylaxis and Treatment of VZV and HSV Infections in Children - VALID 0

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: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Raspberry
Raspberry taste valacyclovir solution
Drug: Valacyclovir
Children of 4-8 years will taste 2 ml of each solution and children of 8-12 years and the parent(s) will taste 4 ml of each solution.
Other Name: 50 mg/ml valacyclovir solution
Experimental: Orange
Orange taste valacyclovir solution
Drug: Valacyclovir
Children of 4-8 years will taste 2 ml of each solution and children of 8-12 years and the parent(s) will taste 4 ml of each solution.
Other Name: 50 mg/ml valacyclovir solution
Active Comparator: Plain
Plain valacyclovir solution
Drug: Valacyclovir
Children of 4-8 years will taste 2 ml of each solution and children of 8-12 years and the parent(s) will taste 4 ml of each solution.
Other Name: 50 mg/ml 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

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Adilia Warris, MD Radboud University
  More Information

No publications provided

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: August 28, 2013
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:
Chickenpox
Herpes Zoster
Herpes Simplex
Virus Diseases
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Pharmaceutical Solutions
Valacyclovir
Acyclovir
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 18, 2014