At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,727 enrolled
Drug / intervention
Acyclovir Lauriad +1 moredrug
Likely dose
Acyclovir Lauriad 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Double-Blind, Single Dose, One-Day Early Administration, Multicentre Study Comparing the Efficacy and Safety of Acyclovir Lauriad® 50 mg Muco-adhesive Buccal Tablet to Matching Placebo, in the Treatment of Herpes Labialis in Immunocompetent Patients.
In Brief
A Phase 3 clinical trial evaluating Acyclovir Lauriad and Placebo for Herpes Labialis. Completed, enrolled 1,727 participants across 53 sites in 7 countries.
Detailed Summary
To demonstrate the efficacy of a single dose of acyclovir Lauriad® 50mg muco-adhesive buccal tablet versus a single dose of matching placebo on the primary vesicular lesion of cold sore.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHerpes Labialis
CountriesAustralia, Czechia, France, Germany, Poland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2007
First PostedOct 2008
Primary CompletionNov 2008
Study CompletionAug 2009
TodayJul 2026
First PostedOct 9, 2008
Enrollment StartMay 1, 2007
Primary CompletionNov 1, 2008
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.7 years ago
Interventions
Acyclovir Lauriaddrug
50 mg muco-adhesive buccal tablets, single application on the gum
Placebodrug
50 mg muco-adhesive buccal tablets, single application on the gum