NL-OMON43617
Recruiting
Not Applicable
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: palatability testing
niversitair Medisch Centrum0 sites60 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- chickenpox
- Sponsor
- niversitair Medisch Centrum
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Subject is at least 4 years of age.
- •2\. Subject is capable of performing the taste assessment, according to the investigator\*s judgement.
- •3\. The child is willing to participate in the taste assessment.
- •4\. 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
- •1\. Documented history of sensitivity/idiosyncrasy to medicinal products or excipients (as used in the study formulation). An exception is a sensitivity reaction on asparaginase, since this is a common reaction in children, and no cross sensitivity with other medicinal products has been demonstrated.
- •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 (not included in standard protocol for treatment of underlying disease) that influences taste perception, as described in the label information).
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
Palatability testing of a new paediatric formulation of valacyclovirHerpes 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]EUCTR2012-000577-22-NLRadboud University Nijmegen Medical Centre64
Completed
Not Applicable
New Paediatric Formulation of Tachipirina®HealthyNCT06358586Aziende Chimiche Riunite Angelini Francesco S.p.A20
Active, not recruiting
Phase 1
Palatability testing in children of a new paediatric formulation of Racecadotril as oral suspension strawberry-flavored administered via an oral graduated syringe compared to the current formulation (apricot-flavored oral powder in sachet to be diluted).Young healthy volunteers (7-12 years)MedDRA version: 19.1Level: LLTClassification code 10055955Term: Acute diarrhoeaSystem Organ Class: 100000004856Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]EUCTR2017-000278-13-FRBIOPROJET PHARMA40
Completed
Phase 4
Palatability Testing of a New Paediatric Formulation of ValacyclovirVaricella Zoster Virus InfectionHerpes Simplex Virus InfectionNCT01682109Radboud University Medical Center41
Completed
Not Applicable
Acceptability study of a new paediatric formulation of Orphacol® (cholic acid) in paediatric patients treated for inborn errors in primary bile acid synthesis due to 3ß-Hydroxy-?5-C27- steroid oxidoreductase deficiency or ?4-3-Oxosteroid-5ß-reductase deficiency.K76.8Other specified diseases of liverDRKS00013645aboratoires CTRS4