Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361881
Status:
COMPLETED
Last Update Posted:
2008-08-18
First Post:
2006-08-08
Brief Title:
Efficacy and Safety Study of ME-609 and Acyclovir for Treatment of Herpes Simplex Labialis
Sponsor:
Medivir
Organization:
Medivir
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None