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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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: Genital Herpes Herpes Simplex Sexually Transmitted Diseases

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

No publications provided

Responsible Party:	Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc.
ClinicalTrials.gov Identifier:	NCT00486200 History of Changes
Other Study ID Numbers:	15L-CL-101
Study First Received:	June 12, 2007
Last Updated:	January 4, 2010
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 Genitalis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases

Genital Diseases, Male
Genital Diseases, Female
Valacyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012