Official Title: “Dose-Finding Study of ASP2151 in Subjects With Herpes Zoster- A Multicenter, Randomized, Double-Blind, Valacyclovir Hydrochloride-Controlled, Parallel-Group, Comparative Study”

To investigate the efficacy and safety of three different doses of ASP2151, as compared to valacyclovir hydrochloride in subjects with herpes zoster, and to determine the recommended clinical dose.

Study Type: Interventional

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

Study Primary Completion Date: September 2008

Intervention(s) in this Clinical Trial

• Drug: ASP2151
  • oral
• Drug: Valacyclovir hydrochloride
  • oral

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • ASP2151 low dose
• Experimental: 2
  • ASP2151 middle dose
• Experimental: 3
  • ASP2151 high dose
• Active Comparator: 4

Primary Measures

• To compare the efficacy and safety of ASP2151 with valacyclovir in subjects with Herpes Zoster
  • Time Frame: 3 months
    Safety Issue?: No

Secondary Measures

• Improvement of cutaneous symptoms and pain
  • Time Frame: 3 months
    Safety Issue?: No

Inclusion Criteria:

• Subjects aged from 20 years to under 80 years on the day informed consent is obtained
• Subjects to whom the study drugs can be orally administered within 72 hours after the onset of rash due to herpes zoster
• Subjects in whom protocol-specified observations and assessments are considered possible

Exclusion Criteria:

• Subjects with extremely compromised immune function due to underlying diseases, treatment with Immunosuppressive agents etc., or radiotherapy
• Subjects with a serious underlying disease that corresponds to Grade 3 in the Classification Criteria for teh Seriousness of Adverse Drug Reactions
• Subjects with concurrent malignant tumors, or those with a history of malignant tumors within the past 5 years

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 79 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Astellas Pharma Inc

Overall Clinical Trial Officials and Contacts

Use Central Contact Study Chair Astellas Pharma Inc  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00487682

Study ID Number: 15L-CL-221

ClinicalTrials.gov Identifier: NCT00487682

Health Authority: Japan: Ministry of Health, Labor and Welfare