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

August 14, 2008 updated by: Medivir

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1443

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Coastal Caroline Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 5 days
5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Episode duration
Time Frame: until healing
until healing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medivir

Investigators

  • Principal Investigator: Christopher M Hull, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 8, 2006

First Submitted That Met QC Criteria

August 8, 2006

First Posted (Estimate)

August 9, 2006

Study Record Updates

Last Update Posted (Estimate)

August 18, 2008

Last Update Submitted That Met QC Criteria

August 14, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 609-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Herpes Labialis

Clinical Trials on ME-609

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe