Dose-finding Study of ASP2151 in Subjects With Herpes Zoster
- Sponsor
- Astellas Pharma Inc
- Study ID
- NCT00487682
- Phase
- PHASE2
- Status
- Completed
Conditions
- Herpes Zoster
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - 79 Years
- Healthy Volunteers
- Not accepted
Interventions
- ASP2151 — DRUGoral
- Valacyclovir hydrochloride — DRUGoral
Study Details
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.
Key Dates
- Start date
- Nov 13, 2007
- Status verified
- Nov 2018
- Primary completion
- Sep 1, 2008
- Completion
- Sep 1, 2008
Study Design
- Enrollment
- 403 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: 1ASP2151 low dose
- Experimental: 2ASP2151 middle dose
- Experimental: 3ASP2151 high dose
- Active Comparator: 4Valacyclovir hydrochloride
Primary Outcome Measure
To compare the efficacy and safety of ASP2151 with valacyclovir in subjects with Herpes Zoster [ Time Frame: 3 months ]
Related Studies
- Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control PopulationPHASE1/PHASE2 · Recruiting · National Institute of Allergy and Infectious Diseases (NIAID) · Bethesda, Maryland