A Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes - Tabular View

Tracking Information

First Received Date ^ICMJE

June 12, 2007

Last Updated Date

September 22, 2008

Start Date ^ICMJE

June 2007

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To compare the efficacy and safety of ASP2151 with valacyclovir and placebo in the acute treatment of recurrent genital Herpes Simplex Virus Infection [ Time Frame: 17 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To compare the efficacy and safety of ASP2151 with valacyclovir and placebo in the acute treatment of recurrent genital Herpes Simplex Virus Infection

Change History

Complete list of historical versions of study NCT00486200 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pharmacokinetics in study patients [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Pharmacokinetics in study patients

Descriptive Information

Brief Title ^ICMJE

A Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes

Official Title ^ICMJE

A Phase II, Dose-Finding Study With ASP2151 in Subjects With Recurrent Episodes of Genital HErpes

Brief Summary

A study of ASP2151 in subjects with recurrent outbreaks of genital herpes.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Herpes Genitalis

Intervention ^ICMJE

Drug: ASP2151
Drug: valacyclovir
Drug: Placebo

Study Arms / Comparison Groups

Experimental: Dosing regimen 1
Experimental: Dosing regimen 2
Experimental: Dosing regimen 3
Experimental: Dosing regimen 4

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

695

Completion Date

August 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subject has a history of genital HSV documented by laboratory testing at screening
Subject has experienced 4 or more episodes of genital herpes during the past 12 months

Exclusion Criteria:

Subject is immunocompromised

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

NCT00486200

Responsible Party

Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc.

Study ID Numbers ^ICMJE

15L-CL-101

Study Sponsor ^ICMJE

Astellas Pharma Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Use Central Contact

Astellas Pharma US, Inc.

Information Provided By

Astellas Pharma Inc

Verification Date

September 2008

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