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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT00486200

Collaborator

(none)

695

Enrollment

Locations

Arms

13.7

Actual Duration (Months)

27.8

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Jun 21, 2007

Actual Primary Completion Date :

Aug 12, 2008

Actual Study Completion Date :

Aug 12, 2008

Arms and Interventions

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.

Outcome Measures

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 [17 days]

Secondary Outcome Measures

Pharmacokinetics in study patients [4 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	State	Country	Postal Code
1	Birmingham	Alabama	United States	35294
2	Phoenix	Arizona	United States	85015
3	Tucson	Arizona	United States	85712
4	Los Angeles	California	United States	90017
5	Sacramento	California	United States	95821
6	San Diego	California	United States	92108
7	Westlake Village	California	United States	91361
8	Denver	Colorado	United States	80262
9	Boynton Beach	Florida	United States	33472
10	Miami	Florida	United States	33156
11	Atlanta	Georgia	United States	30328
12	Indianapolis	Indiana	United States	46202
13	Madisonville	Kentucky	United States	42431
14	Baltimore	Maryland	United States	21201
15	Billings	Montana	United States	59101
16	Omaha	Nebraska	United States	68134
17	Albuquerque	New Mexico	United States	87131
18	Portland	Oregon	United States	97210
19	Philadelphia	Pennsylvania	United States	19103
20	Arlington	Texas	United States	76011
21	Houston	Texas	United States	77030
22	Houston	Texas	United States	77058
23	Salt Lake City	Utah	United States	84132
24	Annandale	Virginia	United States	22003
25	Seattle	Washington	United States	98122