Palatability Testing of a New Paediatric Formulation of Valacyclovir

Phase 4

Completed

• Conditions: Varicella Zoster Virus Infection; Herpes Simplex Virus Infection
• Interventions: Drug: Valacyclovir

• Registration Number: NCT01682109
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-05
• Study First Submitted QC: 2012-09-07
• Study First Posted: 2012-09-10
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-04
• Last Update Posted: 2020-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
reference valacyclovir formulation	Valacyclovir	Formulation derived from FDA label information
new paediatric valacyclovir formulation	Valacyclovir	Newly developed formulation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Radboud University Medical Center; 🇳🇱 Nijmegen, Netherlands