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Antiviral

Valacyclovir for Cold Sores

Phase 2
Waitlist Available
Research Sponsored by St. Justine's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Fever (>38.5° rectal, >38° oral)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weks
Awards & highlights

Study Summary

This trial will test whether the drug Valacyclovir can decrease the duration of symptoms associated with primary herpetic gingivostomatitis in young children.

Eligible Conditions
  • Cold Sores

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Duration of feeding and/or drinking difficulties
Secondary outcome measures
adverse side effects
duration of fever
duration of oral lesions
+4 more

Side effects data

From 2011 Phase 3 trial • 91 Patients • NCT00031486
40%
Nausea
30%
Headache
18%
Urinary tract infection
18%
Depression
15%
Fatigue
13%
Insomnia
13%
Anxiety
10%
Constipation
10%
Vomiting
10%
Dyspepsia
10%
Weight decreased
10%
Hypoaesthesia
8%
Blood creatinine increased
8%
Syncope
8%
Pyrexia
8%
Tremor
8%
Chest pain
5%
Irritability
5%
Parosmia
5%
White blood cells urine positive
5%
Reticulocyte count abnormal
5%
Back pain
5%
Dizziness
5%
Encephalitis herpes
5%
Muscular weakness
5%
Paraesthesia
5%
Dysgeusia
5%
Hallucinaion
5%
Convulsion
5%
Ageusia
5%
Alanine aminotransferase increased
5%
Arthralgia
5%
Candidiasis
5%
Hyperreflexia
3%
Blood urea
3%
Creatinine renal clearance decreased
3%
Depressed level of consciousness
3%
Stress
3%
Confusional state
3%
Retinal ischaemia
3%
Blood uric acid abnormal
3%
Meralgia paraesthetica
3%
Weight increased
3%
Nightmares
3%
Oedema peripheral
3%
Blood uric acid decreased
3%
Osteoarthritis
3%
Abdominal pain
3%
Dysaesthesia
3%
Amnesia
3%
Pharyngitis
3%
Vulvovaginal mycotic infection
3%
Suicide attempt
3%
Aphthous stomatitis
3%
Diarrhoea
3%
Dysphagia
3%
Asthenia
3%
Embolism
3%
Encephalitis
3%
Fall
3%
Papillary thyroid cancer
3%
Pulmonary embolism
3%
Wound infection
3%
Abdominal discomfort
3%
Abdominal distension
3%
Abdominal pain upper
3%
Blood alkaline phosphatase increased
3%
Blood creatinine abnormal
3%
Blood glucose abnormal
3%
Eosinophil count abnormal
3%
Feeling cold
3%
Gingivitis
3%
Global anmesia
3%
Haematocrit abnormal
3%
Haemoglobin abnormal
3%
Haemoglobin decreased
3%
Haemorrhage intracranial
3%
Musculoskeletal discomfort
3%
Musculoskeletal disorder
3%
Neck pain
3%
Nervousness
3%
Neutrophil count abnormal
3%
Panic attack
3%
Pharyngitis streptococcal
3%
Sialoadenitis
3%
Tooth loss
3%
Upper respiratory tract infection
3%
Urine analysis abnormal
3%
Urosepsis
3%
Dry mouth
3%
Billiary dyskinesia
3%
Brain abscess
3%
Cerebral infarction
3%
Cerebrovascular accident
3%
Coagulopathy
3%
Renal failure acute
3%
Agitation
3%
Alanine aminotransferase abnormal
3%
Anosmia
3%
Diverticulitis
3%
Gingival hyperplasia
3%
Herpes zoster
3%
Loss of consciousness
3%
Migraine
3%
Nystagmus
3%
Radial nerve palsy
3%
Red blood cell count abnormal
3%
Salivary hypersecretion
3%
Lymphadenectomy
3%
Blood glucose increased
3%
Agitated depression
3%
Hyperaesthesia
3%
Hypertonia
3%
Hypomania
3%
Influenza
3%
Obsessive-compulsive disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Valacyclovir
Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ValacyclovirExperimental Treatment1 Intervention
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
Group II: controlPlacebo Group1 Intervention
placebo pill
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valacyclovir
2008
Completed Phase 4
~2520

Find a Location

Who is running the clinical trial?

St. Justine's HospitalLead Sponsor
195 Previous Clinical Trials
79,212 Total Patients Enrolled
Canadian Association of Emergency PhysiciansIndustry Sponsor
8 Previous Clinical Trials
965 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Valacyclovir have a history of being tested in clinical trials?

"As of now, there are 13 active clinical trials investigating Valacyclovir with 1 trials in Phase 3. While the majority of the studies for Valacyclovir are based in Montreal, Quebec, there are 204 locations running studies for Valacyclovir."

Answered by AI

What are the primary purposes for which people take Valacyclovir?

"Valacyclovir, which is most often used to treat genital herpes, can also be an effective treatment for human immunodeficiency virus type 1 (hiv-1) infection, herpes labialis, and chickenpox."

Answered by AI

Are any adults above the age of 20 currently enrolled in this research?

"According to the age requirements set out in this clinical trial, the minimum age for participation is 1 year old while the maximum age is 8 years old."

Answered by AI

What are the short and long-term risks associated with taking Valacyclovir?

"While Phase 2 trials have not provided efficacy data, there is some evidence supporting Valacyclovir's safety. Therefore, it received a score of 2."

Answered by AI

Could you share how many people are included in this research project?

"Yes, according to clinicaltrials.gov, this trial is currently open and looking for patients. The listing says that the study was posted on 7/1/2016 and updated as recently as 5/3/2022. They are admitting a total of 80 participants at 1 site."

Answered by AI

Does this experiment have room for more test subjects?

"Yes, the information on clinicaltrials.gov says that this clinical trial is actively looking for patients. The clinical trial was originally posted on 7/1/2016 and was last updated on 5/3/2022. The clinical trial is enrolling 80 patients across 1 sites."

Answered by AI

Could I potentially join this clinical trial as a research subject?

"This clinical trial is open to patients who have stomatitis and are between 1 and 8 years old. The research team is looking to recruit approximately 80 participants."

Answered by AI

Have similar investigations been conducted in the past?

"Since 2006, when the first study on valacyclovir was completed, this medication has undergone extensive research. In fact, there are 13 ongoing studies in 4 countries across 125 cities."

Answered by AI
~9 spots leftby Mar 2025