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

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00486200

  Show 25 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Study Director: Use Central Contact Astellas Pharma US, Inc.
  More Information

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

Keywords provided by Astellas Pharma Inc:
Herpes Genitalis
Herpes Simplex Virus Genital Infection
Genital Herpes
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
Antiviral Agents
Anti-Infective Agents processed this record on May 22, 2017