Official Title: “A Phase II, Dose-Finding Study With ASP2151 in Subjects With Recurrent Episodes of Genital HErpes”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• Drug: ASP2151
  • Oral administration.
• Drug: valacyclovir
  • Oral administration of active comparator.
• Drug: Placebo
  • Oral administration of placebo.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Placebo Comparator: 2
• Experimental: 3
  • Dosing regimen 1
• Experimental: 4
  • Dosing regimen 2
• Experimental: 5
  • Dosing regimen 3
• Experimental: 6
  • Dosing regimen 4

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• Pharmacokinetics in study patients
  • Time Frame: 4 days
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Astellas Pharma Inc

Overall Clinical Trial Officials and Contacts

Use Central Contact Study Director Astellas Pharma US, Inc.  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00486200

Study ID Number: 15L-CL-101

ClinicalTrials.gov Identifier: NCT00486200

Health Authority: United States: Food and Drug Administration