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

Official Title

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

Conditions

  • Herpes Genitalis

Study Type

Interventional

Study Design

Treatment, Randomised, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study.

Further Details

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

Secondary Outcome Measures:

  • Pharmacokinetics in study patients

For more infomation visit Clinicaltrials.gov

Study Start

June 2007

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years and older
  • Genders Eligible for Study: Both
  • Accepts Healthy Volunteers: No

Inclusion Criteria:

  • History of genital HSV documented by laboratory testing at screening
  • 4 or more episodes of genital herpes during the past 12 months  

Exclusion Criteria:

  • Subject is immunocompromised

Total Enrolment

Estimated to be 650

Contact Details

Please refer to this study by its ClinicalTrials.gov identifier: NCT00486200 

Contact:

Astellas Pharma US Medical Information  
Phone number: 800-727-7003
Email: clintrials.info@us.astellas.com