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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00486200
First Posted: June 14, 2007
Last Update Posted: March 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Pharmacokinetics in study patients [ Time Frame: 4 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: June 12, 2007
First Posted: June 14, 2007
Last Update Posted: March 4, 2013
Last Verified: February 2013

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