Palatability Testing of a New Paediatric Formulation of Valacyclovir
- Sponsor
- Radboud University Medical Center
- Study ID
- NCT01682109
- Phase
- PHASE4
- Status
- Completed
Conditions
- Herpes Simplex Virus Infection
- Varicella Zoster Virus Infection
Eligibility Criteria
- Sex
- ALL
- Age
- 4 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Valacyclovir — DRUG
Study Details
Palatability testing of a new paediatric formulation of valacyclovir in children 4-12 years of age and at least one of their parents. Children will be included, who received (val)acyclovir prophylaxis in the past, or will probably need it in the future i.e. children with primary immune deficiency or cancer.
Key Dates
- Start date
- Sep 30, 2012
- Status verified
- Dec 2020
- Primary completion
- Mar 31, 2016
- Completion
- Mar 31, 2016
Study Design
- Enrollment
- 41 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Experimental: new paediatric valacyclovir formulationNewly developed formulation
- Active Comparator: reference valacyclovir formulationFormulation derived from FDA label information
Primary Outcome Measure
Selection of oral solution with best taste [ Time Frame: Day 1 ]