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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 - VALID 0


Phase 4
4 Years
N/A
Open (Enrolling)
Both
Varicella Zoster Virus Infection, Herpes Simplex Virus Infection

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Trial Information

Palatability Testing of a New Paediatric Formulation of Valacyclovir for the Prophylaxis and Treatment of VZV and HSV Infections in Children - VALID 0


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).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Selection of oral solution with best taste

Outcome Description:

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.

Outcome Time Frame:

Day 1

Safety Issue:

No

Principal Investigator

Adilia Warris, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radboud University

Authority:

Netherlands: Ministry of Health, Welfare and Sport

Study ID:

UMCN-AKF 11.05

NCT ID:

NCT01682109

Start Date:

September 2012

Completion Date:

December 2012

Related Keywords:

  • Varicella Zoster Virus Infection
  • Herpes Simplex Virus Infection
  • prophylaxis
  • herpes zoster
  • herpes simplex
  • valacyclovir
  • palatability
  • paediatric
  • Chickenpox
  • Herpes Zoster
  • Herpes Simplex
  • Virus Diseases

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