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

NCT ID: NCT00486200

Last Updated: 2017-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

695 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-21

Study Completion Date

2008-08-12

Brief Summary

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

Detailed Description

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Conditions

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Herpes Genitalis

Keywords

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ASP2151 Herpes Genitalis Sexually Transmitted Disease Herpes Simplex Virus Genital Infection Treatment Outcome Genital Herpes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Oral administration of active comparator

Group Type ACTIVE_COMPARATOR

valacyclovir

Intervention Type DRUG

Oral administration of active comparator.

2

Oral administration of placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral administration of placebo.

3

Dosing regimen 1

Group Type EXPERIMENTAL

ASP2151

Intervention Type DRUG

Oral administration.

4

Dosing regimen 2

Group Type EXPERIMENTAL

ASP2151

Intervention Type DRUG

Oral administration.

5

Dosing regimen 3

Group Type EXPERIMENTAL

ASP2151

Intervention Type DRUG

Oral administration.

6

Dosing regimen 4

Group Type EXPERIMENTAL

ASP2151

Intervention Type DRUG

Oral administration.

Interventions

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ASP2151

Oral administration.

Intervention Type DRUG

valacyclovir

Oral administration of active comparator.

Intervention Type DRUG

Placebo

Oral administration of placebo.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Use Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma US, Inc.

Locations

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Birmingham, Alabama, United States

Site Status

Phoenix, Arizona, United States

Site Status

Tucson, Arizona, United States

Site Status

Los Angeles, California, United States

Site Status

Sacramento, California, United States

Site Status

San Diego, California, United States

Site Status

Westlake Village, California, United States

Site Status

Denver, Colorado, United States

Site Status

Boynton Beach, Florida, United States

Site Status

Miami, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Indianapolis, Indiana, United States

Site Status

Madisonville, Kentucky, United States

Site Status

Baltimore, Maryland, United States

Site Status

Billings, Montana, United States

Site Status

Omaha, Nebraska, United States

Site Status

Albuquerque, New Mexico, United States

Site Status

Portland, Oregon, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Arlington, Texas, United States

Site Status

Houston, Texas, United States

Site Status

Houston, Texas, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Annandale, Virginia, United States

Site Status

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22351940 (View on PubMed)

Related Links

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https://astellasclinicalstudyresults.com/study.aspx?ID=231

Link to results on the Astellas Clinical Study Results website.

Other Identifiers

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15L-CL-101

Identifier Type: -

Identifier Source: org_study_id