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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
June 12, 2007
June 14, 2007
March 4, 2013
June 2007
August 2008   (Final data collection date for primary outcome measure)
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 ]
To compare the efficacy and safety of ASP2151 with valacyclovir and placebo in the acute treatment of recurrent genital Herpes Simplex Virus Infection
Complete list of historical versions of study NCT00486200 on ClinicalTrials.gov Archive Site
Pharmacokinetics in study patients [ Time Frame: 4 days ]
Pharmacokinetics in study patients
Not Provided
Not Provided
 
A Study With ASP2151 in Subjects With Recurrent Episodes of Genital Herpes
A Phase II, Dose-Finding Study With ASP2151 in Subjects With Recurrent Episodes of Genital HErpes
A study of ASP2151 in subjects with recurrent outbreaks of genital herpes.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Herpes Genitalis
  • Drug: ASP2151
    Oral administration.
  • Drug: valacyclovir
    Oral administration of active comparator.
  • Drug: Placebo
    Oral administration of placebo.
  • Active Comparator: 1
    Intervention: Drug: valacyclovir
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
  • Experimental: 3
    Dosing regimen 1
    Intervention: Drug: ASP2151
  • Experimental: 4
    Dosing regimen 2
    Intervention: Drug: ASP2151
  • Experimental: 5
    Dosing regimen 3
    Intervention: Drug: ASP2151
  • Experimental: 6
    Dosing regimen 4
    Intervention: Drug: ASP2151
Tyring S, Wald A, Zadeikis N, Dhadda S, Takenouchi K, Rorig R. ASP2151 for the treatment of genital herpes: a randomized, double-blind, placebo- and valacyclovir-controlled, dose-finding study. J Infect Dis. 2012 Apr 1;205(7):1100-10. doi: 10.1093/infdis/jis019. Epub 2012 Feb 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
695
August 2008
August 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00486200
15L-CL-101
No
Not Provided
Not Provided
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Director: Use Central Contact Astellas Pharma US, Inc.
Astellas Pharma Inc
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP