Herpetic GingivostomatitisPhase 2NCT02738229

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

A Phase 2 study testing Valacyclovir in people with Herpetic Gingivostomatitis, run by St. Justine's Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 1 year to 8 years
Conditions the study is for: Herpetic Gingivostomatitis
What is being tested?: Valacyclovir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 80 participants
Where: 1 siteCanada
Study dates: Jul 2016to Dec 2022
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 8 years
All sexes
No healthy volunteers
Child

Who may be able to join

Children from 10 to 28 Kg of weight. The inclusion of participants is based on weight for practical/feasibility reasons because the study medication will be provided in tablet format. The lower limit of 10 kg is to limit to three strata of weight and limit costs engendered by the preparation of medication.
Clinical diagnosis of herpetic gingivostomatitis according to the treating physician. This is described by the presence of:
Fever (>38.5° rectal, >38° oral) AND
Vesicular or ulcerative lesions located in the anterior of the mouth
Associated or not with perioral vesicular lesions Visiting the emergency department within the first 96 hours of the disease begin.

Who cannot join

Duration of fever > 4 days
Hospitalised patients
Immunocompromised patients
Patients with known hypersensitivity to Valacyclovir
Patients with renal failure
Children with complete incapacity of oral treatment intake
Unable to be contacted for phone follow-up

Trial locations and contacts

1 site in 1 country.

Canada1 site

CHU Sainte-Justine
Montreal, Quebec, H3T1C5

Other trials in Canada

About this study

Official title: Should We Use Oral Valacyclovir in Acute Herpetic Gingivostomatitis in Children? A Randomized Controlled Trial

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.

Conditions: Herpetic Gingivostomatitis
Being tested: Valacyclovir, placebo
Medical subject headings: Stomatitis, Herpetic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ValacyclovirDrug
placeboDrug

Study groups in NCT02738229
Study group	Role	What they receive
Valacyclovir	Experimental	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 Receives: Drug: Valacyclovir
control	Placebo comparator	placebo pill Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

duration of fever
Measured: 2 weeks
duration of pain
Measured: 2 weeks
duration of oral lesions
Measured: 2 weeks
global parent satisfaction
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
Measured: 2 weeks
duration of school or work absence
Measured: 2 weeks
utilisation of medical resources
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
Measured: 2 weeks
adverse side effects
Measured: 2 weks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2016Dec 2022

First posted14 Apr 2016 (estimated)
Study startJul 2016
Primary completionDec 2022
Study completionDec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Herpetic GingivostomatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02738229
Sponsor's protocol ID: Valtrex for HGS
Status last verified: Apr 2023
First submitted: 5 Apr 2016
Last updated: 11 Apr 2023
Results posted: No
Data monitoring committee: Yes
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Should We Use Oral Valacyclovir in Acute Herpetic Gingivostomatitis in Children? A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02738229
Acronym / sponsor ID: Valtrex for HGS
Conditions: Herpetic Gingivostomatitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: St. Justine's HospitalUniversity, hospital or other
Collaborators: Canadian Association of Emergency Physicians
Study start: Jul 2016
Primary completion: Dec 2022 (actual)
Study completion: Dec 2022 (actual)
First posted: 14 Apr 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Valacyclovir	Experimental	Drug: 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
control	Placebo comparator	Drug: placeboplacebo pill

Who may qualify

Ages: 1 year to 8 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Children from 10 to 28 Kg of weight. The inclusion of participants is based on weight for practical/feasibility reasons because the study medication will be provided in tablet format. The lower limit of 10 kg is to limit to three strata of weight and limit costs engendered by the preparation of medication.
Clinical diagnosis of herpetic gingivostomatitis according to the treating physician. This is described by the presence of:

Key exclusion criteria (7 listed)

Duration of fever > 4 days
Hospitalised patients
Immunocompromised patients
Patients with known hypersensitivity to Valacyclovir
Patients with renal failure

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Valacyclovir	Drug	Valacyclovir
placebo	Drug	control

Primary outcome

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

7 secondary outcomes

duration of fever
Time frame: 2 weeks
duration of pain
Time frame: 2 weeks
duration of oral lesions
Time frame: 2 weeks
global parent satisfaction
Time frame: 2 weeks
duration of school or work absence
Time frame: 2 weeks
utilisation of medical resources
Time frame: 2 weeks
adverse side effects
Time frame: 2 weks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Valacyclovir in people with Herpetic Gingivostomatitis, run by St. Justine's Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of feeding and/or drinking difficulties (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02738229.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.