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

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.
ClinicalTrials.gov Identifier: NCT00486200
Recruitment Status : Completed
First Posted : June 14, 2007
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
A study of ASP2151 in subjects with recurrent outbreaks of genital herpes.

Condition or disease Intervention/treatment Phase
Herpes Genitalis Drug: ASP2151 Drug: valacyclovir Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 695 participants
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
Actual Study Start Date : June 21, 2007
Primary Completion Date : August 12, 2008
Study Completion Date : August 12, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genital Herpes
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
Oral administration of active comparator
Drug: valacyclovir
Oral administration of active comparator.
Placebo Comparator: 2
Oral administration of placebo
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.



Primary Outcome Measures :
  1. 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 :
  1. Pharmacokinetics in study patients [ Time Frame: 4 days ]


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

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.

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00486200     History of Changes
Other Study ID Numbers: 15L-CL-101
First Posted: June 14, 2007    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:
ASP2151
Herpes Genitalis
Sexually Transmitted Disease
Herpes Simplex Virus Genital Infection
Treatment Outcome
Genital Herpes

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