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

Sponsor

Medivir (Industry)

Overall Status

Completed

CT.gov ID

NCT00361881

Collaborator

(none)

1,443

Enrollment

Location

Arms

Duration (Months)

84.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Herpes Labialis	Drug: ME-609 Drug: acyclovir in ME-609 vehicle Drug: Vehicle	Phase 3

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 of experiencing the first signs or symptoms of a herpes recurrence. The subject visited a study clinic as soon as possible after treatment initiation, but no later than midnight of the following day, for evaluation.

Study Design

Study Type:

Interventional

Actual Enrollment :

1443 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

A Randomized, Double-Blind, Active Controlled, Vehicle-Controlled, Subject Initiated Study Comparing Efficacy and Safety of ME-609 Versus Acyclovir Cream for Treatment of Recurrent Herpes Simplex Labialis

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Aug 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 ME-609	Drug: ME-609 Cream, dose 5 times daily during 5 days.
Active Comparator: 2 Acyclovir in ME-609 vehicle	Drug: acyclovir in ME-609 vehicle Dose 5 times daily for 5 days
Placebo Comparator: 3 Vehicle	Drug: Vehicle Dose 5 times daily for 5 days

Arm

Intervention/Treatment

Experimental: 1

ME-609

Drug: ME-609

Cream, dose 5 times daily during 5 days.

Active Comparator: 2

Acyclovir in ME-609 vehicle

Drug: acyclovir in ME-609 vehicle

Dose 5 times daily for 5 days

Placebo Comparator: 3

Vehicle

Drug: Vehicle

Dose 5 times daily for 5 days

Outcome Measures

Primary Outcome Measures

Proportion of subjects with non-ulcerative recurrences measured as the proportion of subjects in whom the study recurrence did not progress beyond the papule stage. [5 days]

Secondary Outcome Measures

Episode duration [until healing]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Coastal Caroline Research Center	Mt. Pleasant	South Carolina	United States	29464

Sponsors and Collaborators

Medivir

Investigators

Principal Investigator: Christopher M Hull, MD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00361881

Other Study ID Numbers:

609-04

First Posted:

Aug 9, 2006

Last Update Posted:

Aug 18, 2008

Last Verified:

Aug 1, 2008

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2008