NCT00769314

Phase 3 Clinical Study for the Treatment of Cold Sore

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,727 (actual)
• Sponsor: Valerio Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Herpes Labialis

Interventions

Type	Name	Description
DRUG	Acyclovir Lauriad	50 mg muco-adhesive buccal tablets, single application on the gum
DRUG	Placebo	50 mg muco-adhesive buccal tablets, single application on the gum

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-11-01
• Completion: 2009-08-01
• First posted: 2008-10-09
• Last updated: 2012-12-21
• Results posted: 2012-12-21

Locations

53 sites across 7 countries: United States, Australia, Czechia, France, Germany, Poland, United Kingdom