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

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Herpes Simplex

Drug Information available for: Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources

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

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Locations

United States, Alabama

Birmingham, Alabama, United States, 35294
United States, Arizona

Tucson, Arizona, United States, 85712

Phoenix, Arizona, United States, 85015
United States, California

Sacramento, California, United States, 95821

Westlake Village, California, United States, 91361

San Diego, California, United States, 92108

Los Angeles, California, United States, 90017
United States, Colorado

Denver, Colorado, United States, 80262
United States, Florida

Miami, Florida, United States, 33156

Boynton Beach, Florida, United States, 33472
United States, Georgia

Atlanta, Georgia, United States, 30328
United States, Indiana

Indianapolis, Indiana, United States, 46202
United States, Kentucky

Madisonville, Kentucky, United States, 42431
United States, Maryland

Baltimore, Maryland, United States, 21201
United States, Montana

Billings, Montana, United States, 59101
United States, Nebraska

Omaha, Nebraska, United States, 68134
United States, New Mexico

Albuquerque, New Mexico, United States, 87131
United States, Oregon

Portland, Oregon, United States, 97210
United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19103
United States, Texas

Houston, Texas, United States, 77030

Houston, Texas, United States, 77058

Arlington, Texas, United States, 76011
United States, Utah

Salt Lake City, Utah, United States, 84132
United States, Virginia

Annandale, Virginia, United States, 22003
United States, Washington

Seattle, Washington, United States, 98122

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:

Use Central Contact

Astellas Pharma US, Inc.

More Information

No publications provided

Responsible Party:	Astellas Pharma US, Inc. ( Sr Manager Clinical Trial Registry )
Study ID Numbers:	15L-CL-101
Study First Received:	June 12, 2007
Last Updated:	September 22, 2008
ClinicalTrials.gov Identifier:	NCT00486200 History of Changes
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

Additional relevant MeSH terms:

Herpes Simplex
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Herpes Genitalis
Genital Diseases, Male
Antiviral Agents
Pharmacologic Actions

Herpesviridae Infections
Virus Diseases
Genital Diseases, Female
Valacyclovir
Therapeutic Uses
Sexually Transmitted Diseases
DNA Virus Infections

ClinicalTrials.gov processed this record on November 30, 2009