chickenpox herpes
Conditions
Interventions
Three formulations will be tested. Each participant will taste 4 or 8 ml of
each formulation containing 20-25 mg/ml valacyclovir.
Collection of 2 ml of saliva (voluntary) for research on genetics of
Sponsors
Universitair Medisch Centrum
Eligibility
Age
2 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject is at least 4 years of age. 2. Subject is capable of performing the taste assessment, according to the investigator*s judgement. 3. The child is willing to participate in the taste assessment. 4. 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
Exclusion criteria: 1. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients (as used in the study formulation). An exception is a sensitivity reaction on asparaginase, since this is a common reaction in children, and no cross sensitivity with other medicinal products has been demonstrated. 2. 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 (not included in standard protocol for treatment of underlying disease) that influences taste perception, as described in the label information).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A 100 mm facial hedonic scale will be employed to indicate the palatability of each formulation. | — |
Secondary
| Measure | Time frame |
|---|---|
| For (one of) the parents a 100 mm facial hedonic scale will be employed to indicate the palatability of each formulation. They will also fill in a questionnaire to determine which of the formulations they think will have the preference of their child. Also, they have to fill in what basic taste they taste. | — |
Countries
Netherlands
Outcome results
None listed