Dose-finding Study of ASP2151 in Subjects With Herpes Zoster
- Registration Number
- NCT00487682
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 403
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 ASP2151 ASP2151 low dose 2 ASP2151 ASP2151 middle dose 4 Valacyclovir hydrochloride Valacyclovir hydrochloride 3 ASP2151 ASP2151 high dose
- Primary Outcome Measures
Name Time Method To compare the efficacy and safety of ASP2151 with valacyclovir in subjects with Herpes Zoster 3 months
- Secondary Outcome Measures
Name Time Method Improvement of cutaneous symptoms and pain 3 months