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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Astellas Pharma Inc
Study ID
NCT00486200
Phase
PHASE2
Status
Completed

Conditions

  • Herpes Genitalis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ASP2151 — DRUG
    Oral administration.
  • valacyclovir — DRUG
    Oral administration of active comparator.
  • Placebo — DRUG
    Oral administration of placebo.

Study Details

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

Key Dates

Start date
Jun 21, 2007
Status verified
Dec 2017
Primary completion
Aug 12, 2008
Completion
Aug 12, 2008

Study Design

Enrollment
695 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 1
    Oral administration of active comparator
  • Placebo Comparator: 2
    Oral administration of placebo
  • Experimental: 3
    Dosing regimen 1
  • Experimental: 4
    Dosing regimen 2
  • Experimental: 5
    Dosing regimen 3
  • Experimental: 6
    Dosing regimen 4

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 ]

Locations (25)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama35294-
-PhoenixArizona85015-
-TucsonArizona85712-
-Los AngelesCalifornia90017-
-SacramentoCalifornia95821-
-San DiegoCalifornia92108-
-Westlake VillageCalifornia91361-
-DenverColorado80262-
-Boynton BeachFlorida33472-
-MiamiFlorida33156-
-AtlantaGeorgia30328-
-IndianapolisIndiana46202-
-MadisonvilleKentucky42431-
-BaltimoreMaryland21201-
-BillingsMontana59101-
-OmahaNebraska68134-
-AlbuquerqueNew Mexico87131-
-PortlandOregon97210-
-PhiladelphiaPennsylvania19103-
-ArlingtonTexas76011-
-HoustonTexas77030-
-HoustonTexas77058-
-Salt Lake CityUtah84132-
-AnnandaleVirginia22003-
-SeattleWashington98122-