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A Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes
This study has been completed.
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