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OpenTrials
Completed

NCT Number: NCT00486200

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

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

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Key information

Conditions

Herpes Genitalis Communicable Diseases DNA Virus Infections Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Herpes Simplex Herpesviridae Infections Infections Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASP2151

Drug

Oral administration.

Valacyclovir

Drug

Oral administration of active comparator.

Placebo

Drug

Oral administration of placebo.

Primary outcomes

  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 outcomes

  1. Pharmacokinetics in study patients

    Time frame: 4 days

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

A Phase II, Dose-Finding Study With ASP2151 in Subjects With Recurrent Episodes of Genital HErpes

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 14, 2007
Registry last updated
Dec 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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