Herpes Simplex Virus Infection, Varicella Zoster Virus Infection
Conditions
Keywords
prophylaxis, herpes zoster, herpes simplex, valacyclovir, palatability, paediatric
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.
Interventions
DRUGValacyclovir
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Selection of oral solution with best taste | 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
| Measure | Time frame | Description |
|---|---|---|
| Taste assessment | 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. |
| Predictability of palatability preference of the child by parents. | Day 1 | To determine whether parents can predict the palatability preference of their child. |
Countries
Netherlands
Outcome results
None listed