Should We Use Oral Valacyclovir in Acute Herpetic Gingivostomatitis in Children?

Phase 2

Completed

• Conditions: Herpetic Gingivostomatitis
• Interventions: Drug: placebo; Drug: Valacyclovir

• Registration Number: NCT02738229
• Lead Sponsor: St. Justine's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-05
• Study First Submitted QC: 2016-04-08
• Study First Posted: 2016-04-14
• Study Start: 2016-07
• Primary Completion: 2022-12
• Study Completion: 2022-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	placebo	placebo pill
Valacyclovir	Valacyclovir	Valacyclovir 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

Primary Outcome Measures

Name	Time	Method
Duration of feeding and/or drinking difficulties	2 weeks	This will be defined by the number of days until the participants return to normal feeding and eating according to the parents.

Secondary Outcome Measures

Name	Time	Method
duration of fever	2 weeks
global parent satisfaction	2 weeks	Likert scale on how satisfied the parents are with the medication. This will be measured during a follow-up survey at 7 and 14 days following randomisation
duration of pain	2 weeks
duration of school or work absence	2 weeks
utilisation of medical resources	2 weeks	hospitalisation for intra venous hydration, visit to a physician, use of analgesics or other medication. This will be measured during a follow-up survey at 7 and 14 days following randomisation
duration of oral lesions	2 weeks
adverse side effects	2 weks

Trial Locations

Locations (1)

CHU Sainte-Justine; 🇨🇦 Montreal, Quebec, Canada