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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00486200
First received: June 12, 2007
Last updated: February 27, 2013
Last verified: February 2013
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
United States, Arizona
Phoenix, Arizona, United States, 85015
Tucson, Arizona, United States, 85712
United States, California
Los Angeles, California, United States, 90017
Sacramento, California, United States, 95821
San Diego, California, United States, 92108
Westlake Village, California, United States, 91361
United States, Colorado
Denver, Colorado, United States, 80262
United States, Florida
Boynton Beach, Florida, United States, 33472
Miami, Florida, United States, 33156
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
Arlington, Texas, United States, 76011
Houston, Texas, United States, 77058
Houston, Texas, United States, 77030
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

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00486200     History of Changes
Other Study ID Numbers: 15L-CL-101
Study First Received: June 12, 2007
Last Updated: February 27, 2013
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 August 28, 2014