EUCTR2012-000577-22-NL
Active, not recruiting
Phase 1
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
Radboud University Nijmegen Medical Centre0 sites64 target enrollmentJanuary 8, 2013
ConditionsHerpes virus infections, especially Herpes Simplex, Varicella Zoster and CytomegalovirusMedDRA version: 14.1Level: PTClassification code 10019973Term: Herpes virus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
DrugsZelitrex
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Herpes virus infections, especially Herpes Simplex, Varicella Zoster and Cytomegalovirus
- Sponsor
- Radboud University Nijmegen Medical Centre
- Enrollment
- 64
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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)
Outcomes
Primary Outcomes
Not specified
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