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
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

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 April 20, 2014