Palatability Testing of a New Paediatric Formulation of Valacyclovir

Study Overview
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Brief Summary
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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.

Official Title
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Palatability Testing of a New Paediatric Formulation of Valacyclovir for the Prophylaxis and Treatment of VZV and HSV Infections in Children

Conditions
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Varicella Zoster Virus Infection, Herpes Simplex Virus Infection

Intervention / Treatment
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* Drug: Valacyclovir


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: new paediatric valacyclovir formulation<br>Newly developed formulation | Drug: Valacyclovir<br> <br> * Other names: valacyclovir solution;|
| Active Comparator: reference valacyclovir formulation<br>Formulation derived from FDA label information | Drug: Valacyclovir<br> <br> * Other names: valacyclovir solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Selection of oral solution with best taste | 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. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Taste assessment | 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. | Day 1 | 
| Predictability of palatability preference of the child by parents. | To determine whether parents can predict the palatability preference of their child. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prophylaxis, herpes zoster, herpes simplex, valacyclovir, palatability, paediatric