Status:

COMPLETED

Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis

Lead Sponsor:

Medivir

Conditions:

Herpes Labialis

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

The purpose of this study is to determine whether ME-609 is more efficient than acyclovir and placebo for the treatment of recurrent herpes labialis.

Detailed Description

This was a randomized, double-blind, active- and vehicle-controlled study comparing the effects of ME-609, acyclovir in ME-609 vehicle, and vehicle alone. Treatment was subject-initiated within 1 hour...

Eligibility Criteria

Inclusion

  • Generally good health
  • History of recurrent herpes labialis with at last three episodes during the prior 12 months

Exclusion

  • Treatment with antivirals or immunosuppressive agents within 2 weeks prior to randomization
  • Pregnant and/or nursing women
  • Continuous daily treatment with pain medication
  • Significant skin condition that occur in the area of herpes recurrences

Key Trial Info

Start Date :

July 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2007

Estimated Enrollment :

1443 Patients enrolled

Trial Details

Trial ID

NCT00361881

Start Date

July 1 2006

End Date

December 1 2007

Last Update

August 18 2008

Active Locations (1)

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Coastal Caroline Research Center

Mt. Pleasant, South Carolina, United States, 29464