Palatability Testing of a New Paediatric Formulation of Valacyclovir

Varicella Zoster Virus Infection Clinical Trial

— VALID-0  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682109
• Other study ID #: UMCN-AKF 11.05
• Status: Completed
• Phase: Phase 4
• Start date: September 2012
• Est. completion date: March 2016

Study information

• Verified date: December 2020
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Communicable Diseases
• Herpes Simplex
• Herpes Simplex Virus Infection
• Herpes Zoster
• Infection
• Varicella Zoster Virus Infection
• Virus Diseases

Intervention

Drug:
• Valacyclovir

Locations

Country	Name	City	State
Netherlands	Radboud University Medical Center	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

Bastiaans DET, Immohr LI, Zeinstra GG, Strik-Albers R, Pein-Hackelbusch M, van der Flier M, de Haan AFJ, Boelens JJ, Lankester AC, Burger DM, Warris A. In vivo and in vitro palatability testing of a new paediatric formulation of valaciclovir. Br J Clin Ph — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Predictability of palatability preference of the child by parents.	To determine whether parents can predict the palatability preference of their child.	Day 1