Palatability testing of a new paediatric formulation of valacyclovir

Palatability testing of a new paediatric formulation of valacyclovir for the prophylaxis and treatment of VZV and HSV infections in children – VALID 0 - VALID-0

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000577-22-NL

Enrollment

Registered

2013-01-08

Start date

2012-07-17

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes virus infections, especially Herpes Simplex, Varicella Zoster and Cytomegalovirus MedDRA version: 14.1 Level: PT Classification code 10019973 Term: Herpes virus infection System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Zelitrex Product Name: valacyclovir solution Pharmaceutical Form: Oral solution INN or Proposed INN: valaciclovirum CAS Number: 124832-27-5 Current Sponsor code: valaciclovir Other descrip

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subject is at least 4 years of age. 2. Subject weighs at least 15 kg. 3. Subject is capable of performing the taste assessment, according to the investigator’s judgement. 4. The child is willing to participate in the taste assessment. 5. 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. Are the trial subjects under 18? yes Number of subjects for this age range: 35 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients. 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 that influences taste perception, as described in the label information)

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine which of three newly developed formulations of valacyclovir is accepted best in children.;Secondary Objective: To determine whether parents can predict the palatability preference of their child.;Primary end point(s): Mean palatability score (as scored on a 100 mm VAS combined with a facial hedonic scale) for each formulation;Timepoint(s) of evaluation of this end point: day 1	—

Measure

Time frame

Main Objective: To determine which of three newly developed formulations of valacyclovir is accepted best in children.;Secondary Objective: To determine whether parents can predict the palatability preference of their child.;Primary end point(s): Mean palatability score (as scored on a 100 mm VAS combined with a facial hedonic scale) for each formulation;Timepoint(s) of evaluation of this end point: day 1

—

Secondary

Measure	Time frame
Secondary end point(s): Most palatable formulation for a child, according to the parent of the child. ;Timepoint(s) of evaluation of this end point: day 1	—

Countries

Netherlands

Contacts

Public ContactDiane Bastiaans

Radboud University Nijmegen Medical Centre

d.bastiaans@akf.umcn.nl31243616405

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026