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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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks

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

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Duration of feeding and/or drinking difficulties
Secondary study objectives
global parent satisfaction
utilisation of medical resources

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%
Tremor
8%
Chest pain
8%
Blood creatinine increased
8%
Syncope
8%
Pyrexia
5%
Hallucinaion
5%
Reticulocyte count abnormal
5%
Ageusia
5%
Dysgeusia
5%
Irritability
5%
Paraesthesia
5%
White blood cells urine positive
5%
Parosmia
5%
Back pain
5%
Dizziness
5%
Encephalitis herpes
5%
Muscular weakness
5%
Convulsion
5%
Alanine aminotransferase increased
5%
Arthralgia
5%
Candidiasis
5%
Hyperreflexia
3%
Meralgia paraesthetica
3%
Pulmonary embolism
3%
Brain abscess
3%
Papillary thyroid cancer
3%
Cerebral infarction
3%
Renal failure acute
3%
Blood urea
3%
Loss of consciousness
3%
Neck pain
3%
Nervousness
3%
Salivary hypersecretion
3%
Agitation
3%
Blood uric acid abnormal
3%
Cerebrovascular accident
3%
Urine analysis abnormal
3%
Coagulopathy
3%
Creatinine renal clearance decreased
3%
Neutrophil count abnormal
3%
Retinal ischaemia
3%
Blood uric acid decreased
3%
Oedema peripheral
3%
Nightmares
3%
Stress
3%
Agitated depression
3%
Asthenia
3%
Amnesia
3%
Billiary dyskinesia
3%
Blood glucose increased
3%
Confusional state
3%
Depressed level of consciousness
3%
Diverticulitis
3%
Dysaesthesia
3%
Gingival hyperplasia
3%
Haemoglobin decreased
3%
Herpes zoster
3%
Panic attack
3%
Urosepsis
3%
Weight increased
3%
Osteoarthritis
3%
Abdominal pain
3%
Pharyngitis
3%
Vulvovaginal mycotic infection
3%
Suicide attempt
3%
Aphthous stomatitis
3%
Diarrhoea
3%
Dysphagia
3%
Embolism
3%
Encephalitis
3%
Fall
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%
Haemorrhage intracranial
3%
Musculoskeletal discomfort
3%
Musculoskeletal disorder
3%
Pharyngitis streptococcal
3%
Sialoadenitis
3%
Tooth loss
3%
Upper respiratory tract infection
3%
Dry mouth
3%
Alanine aminotransferase abnormal
3%
Anosmia
3%
Migraine
3%
Nystagmus
3%
Radial nerve palsy
3%
Red blood cell count abnormal
3%
Lymphadenectomy
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
200 Previous Clinical Trials
85,760 Total Patients Enrolled
Canadian Association of Emergency PhysiciansIndustry Sponsor
8 Previous Clinical Trials
965 Total Patients Enrolled
~9 spots leftby Oct 2025
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