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Sponsored by: |
Astellas Pharma Inc |
---|---|
Information provided by: | Astellas Pharma Inc |
ClinicalTrials.gov Identifier: | NCT00487682 |
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.
Condition | Intervention | Phase |
---|---|---|
Herpes Zoster |
Drug: ASP2151 Drug: Valacyclovir hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Dose-Finding Study of ASP2151 in Subjects With Herpes Zoster- A Multicenter, Randomized, Double-Blind, Valacyclovir Hydrochloride-Controlled, Parallel-Group, Comparative Study |
Enrollment: | 403 |
Study Start Date: | August 2007 |
Study Completion Date: | September 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
ASP2151 low dose
|
Drug: ASP2151
oral
|
2: Experimental
ASP2151 middle dose
|
Drug: ASP2151
oral
|
3: Experimental
ASP2151 high dose
|
Drug: ASP2151
oral
|
4: Active Comparator |
Drug: Valacyclovir hydrochloride
oral
|
Ages Eligible for Study: | 20 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Astellas Pharma, Inc ( Director ) |
Study ID Numbers: | 15L-CL-221 |
Study First Received: | June 15, 2007 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00487682 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
herpes zoster ASP2151 Valacyclovir hydrochloride |
Valacyclovir Virus Diseases Herpes Zoster Signs and Symptoms |
Acyclovir DNA Virus Infections Herpesviridae Infections |
Anti-Infective Agents Therapeutic Uses Antiviral Agents Pharmacologic Actions |