Palatability testing of a new paediatric formulation of valacyclovir

Phase 1

• Conditions: Herpes virus infections, especially Herpes Simplex, Varicella Zoster and Cytomegalovirus; MedDRA version: 14.1Level: PTClassification code 10019973Term: Herpes virus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-000577-22-NL
• Lead Sponsor: Radboud University Nijmegen Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-08
• Study Completion: 2016-03-30
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 64

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Most palatable formulation for a child, according to the parent of the child.<br><br>;Timepoint(s) of evaluation of this end point: day 1