Safety Study of ME-609 for Treatment of Herpes Simplex La... | NCT00375570

Studies
Safety Study of ME-609 for Treatment of Herpes Simplex Labialis in Adolescents

NCT00375570

Sponsor

Medivir

Status

Completed

Last Update Posted

Aug 18, 2008Estimated

Enrollment

254Actual

Phase

Phase 3

Conditions

Herpes Labialis

Interventions

ME-609

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Sep 2007Actual

Completion Date

Sep 2007Actual

First Submitted Date

Sep 12, 2006

First Submission Date that Met QC Criteria

Sep 12, 2006

First Posted Date

Sep 13, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2008

Last Update Posted Date

Aug 18, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Purpose of this study is to evaluate the safety of ME-609 for the treatment of recurrent herpes labialis in adolescents.

Detailed Description

The objective of the study was to evaluate the safety of ME-609 for the treatment of herpes labialis recurrences in immunocompetent adolescents, 12 - 17 years of age, following a 5-day treatment with 5-time daily topical administration.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

254Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	ME-609	Drug: ME-609

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ME-609	Drug	Topical treatment 5 times daily for 5 days	1

Measure	Description	Time Frame
Adverse Event		3 weeks after last dose

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

General good health
History of recurrent herpes labialis with at two recurrences during the last twelve months

Exclusion Criteria:

Treatment with systemic or topical antiviral agents or steroids within two weeks prior to inclusion
Significant skin condition that occur in the area of herpes recurrences
Nursing or/and pregnancy
Immunosupressed state due to underlying disease (e.g. HIV infection or concomitant treatment (e.g. cancer chemotherapy)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anders Strand, MD PhD	Department of Medical Sciences, Dermatology and Venereology University Hospital, Uppsala, Sweden	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006560	Herpes Labialis

Ancestor Terms

ID	Term
D006561	Herpes Simplex
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C558464	ME 609

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided