Should We Use Oral Valacyclovir in Acute Herpetic Gingivostomatitis in Children?
- Sponsor
- St. Justine's Hospital
- Study ID
- NCT02738229
- Phase
- PHASE2
- Status
- Completed
Conditions
- Herpetic Gingivostomatitis
Eligibility Criteria
- Sex
- ALL
- Age
- 1 Year - 8 Years
- Healthy Volunteers
- Not accepted
Interventions
- Valacyclovir — DRUG
- placebo — DRUG
Study Details
Primary herpetic gingivostomatitis is a frequent problem in pediatrics. Complications of this are dehydration, pain and hospitalisation. The objective of this randomized controlled trial is to assess the clinical efficacy of oral Valacyclovir to decrease the duration of symptoms associated with acute herpes gingivostomatitis in children. This study will involve 80 children aged 1 to 8 years old to receive weight adjusted doses of valacyclovir for 7 days. The primary outcome measure will be the duration (in days) of feeding and/or drinking difficulties.
Key Dates
- Start date
- Jul 31, 2016
- Status verified
- Apr 2023
- Primary completion
- Dec 31, 2022
- Completion
- Dec 31, 2022
Study Design
- Enrollment
- 80 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: ValacyclovirValacyclovir will be given twice a day with following doses according to weight: 10 to 13,9 kg : Valacyclovir 250 mg PO twice per day 14 to 19,9 kg : Valacyclovir 375 mg PO twice per day 20 to 28 kg : Valacyclovir 500 mg PO twice per day
- Placebo Comparator: controlplacebo pill
Primary Outcome Measure
Duration of feeding and/or drinking difficulties [ Time Frame: 2 weeks ]