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Phase 3 Clinical Study for the Treatment of Cold Sore

NCT00769314 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1727

Last updated 2012-12-21

Study results available
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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

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

Sponsors & Collaborators

  • Valerio Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2008-11-30
Completion
2009-08-31

Countries

  • United States
  • Australia
  • Czechia
  • France
  • Germany
  • Poland
  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00769314 on ClinicalTrials.gov