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

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00486200

Purpose

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

Condition	Intervention	Phase
Herpes Genitalis	Drug: ASP2151 Drug: valacyclovir Drug: Placebo	Phase II

MedlinePlus related topics: Herpes Simplex

Drug Information available for: Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources

Study Type:

Interventional

Study Design:

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

Official Title:

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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Enrollment:

695

Study Start Date:

June 2007

Study Completion Date:

August 2008

Primary Completion Date:

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

Arms	Assigned Interventions
1: Active Comparator	Drug: valacyclovir Oral administration of active comparator.
2: Placebo Comparator	Drug: Placebo Oral administration of placebo.
3: Experimental Dosing regimen 1	Drug: ASP2151 Oral administration.
4: Experimental Dosing regimen 2	Drug: ASP2151 Oral administration.
5: Experimental Dosing regimen 3	Drug: ASP2151 Oral administration.
6: Experimental Dosing regimen 4	Drug: ASP2151 Oral administration.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486200

Show 25 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Use Central Contact

Astellas Pharma US, Inc.

More Information

Responsible Party:

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

Study ID Numbers:

15L-CL-101

First Received:

June 12, 2007

Last Updated:

September 22, 2008

ClinicalTrials.gov Identifier:

NCT00486200

Health Authority:

United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Herpes Genitalis
Herpes Simplex Virus Genital Infection
Genital Herpes

ASP2151
Treatment Outcome
Sexually Transmitted Disease

Study placed in the following topic categories:

Valacyclovir
Genital Diseases, Female
Virus Diseases
Herpes Simplex
Signs and Symptoms
Sexually Transmitted Diseases, Viral

Herpes Genitalis
Sexually Transmitted Diseases
DNA Virus Infections
Genital Diseases, Male
Recurrence
Herpesviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 07, 2009