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Palatability Testing of a New Paediatric Formulation of Valacyclovir

Information source: Radboud University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Varicella Zoster Virus Infection; Herpes Simplex Virus Infection

Intervention: Valacyclovir (Drug)

Phase: Phase 4

Status: Suspended

Sponsored by: Radboud University

Official(s) and/or principal investigator(s):
David Burger, Principal Investigator, Affiliation: Radboud University

Summary

Palatability testing of 3 different formulations of a newly developed paediatric valacyclovir oral solution 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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Primary outcome: Selection of oral solution with best taste

Secondary outcome:

Taste assessment

Predictability of palatability preference of the child by parents.

Eligibility

Minimum age: 4 Years. Maximum age: N/A. Gender(s): Both.

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).

Locations and Contacts

Radboud University Medical Center, Nijmegen, Netherlands
Additional Information

Starting date: September 2012
Last updated: September 29, 2014

Page last updated: August 23, 2015

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