NCT01682109
Completed
Phase 4
Palatability Testing of a New Paediatric Formulation of Valacyclovir for the Prophylaxis and Treatment of VZV and HSV Infections in Children
InterventionsValacyclovir
DrugsValacyclovir
Overview
- Phase
- Phase 4
- Intervention
- Valacyclovir
- Conditions
- Varicella Zoster Virus Infection
- Sponsor
- Radboud University Medical Center
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Selection of oral solution with best taste
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility 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).
Arms & Interventions
new paediatric valacyclovir formulation
Newly developed formulation
Intervention: Valacyclovir
reference valacyclovir formulation
Formulation derived from FDA label information
Intervention: Valacyclovir
Outcomes
Primary Outcomes
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
- Taste assessment(Day 1)
- Predictability of palatability preference of the child by parents.(Day 1)
Study Sites (1)
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