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

Tracking Information

First Received Date ^ICMJE

August 8, 2006

Last Updated Date

August 14, 2008

Start Date ^ICMJE

July 2006

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00361881 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Episode duration [ Time Frame: until healing ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 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 Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Herpes Labialis

Intervention ^ICMJE

Drug: ME-609
Drug: acyclovir in ME-609 vehicle
Drug: Vehicle

Study Arms / Comparison Groups

Experimental: ME-609
Active Comparator: Acyclovir in ME-609 vehicle
Placebo Comparator: Vehicle

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1443

Completion Date

December 2007

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00361881

Responsible Party

Börje Darpö, MD, PhD, Medivir AB

Study ID Numbers ^ICMJE

609-04

Study Sponsor ^ICMJE

Medivir

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Christopher M Hull, MD

Unaffiliated

Information Provided By

Medivir

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP