Herpes Zoster
Conditions
Keywords
Valacyclovir hydrochloride, herpes zoster, ASP2151
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.
Interventions
DRUGASP2151
oral
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy and safety of ASP2151 with valacyclovir in subjects with Herpes Zoster | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Improvement of cutaneous symptoms and pain | 3 months |
Countries
Japan
Outcome results
None listed