Dose-Finding Study of ASP2151 in Subjects With Herpes Zoster
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Zoster
Intervention: ASP2151 (Drug); Valacyclovir hydrochloride (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Use Central Contact, Study Chair, Affiliation: Astellas Pharma Inc
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.
Clinical Details
Official title: Dose-Finding Study of ASP2151 in Subjects With Herpes Zoster- A Multicenter, Randomized, Double-Blind, Valacyclovir Hydrochloride-Controlled, Parallel-Group, Comparative Study
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To compare the efficacy and safety of ASP2151 with valacyclovir in subjects with Herpes Zoster
Secondary outcome: Improvement of cutaneous symptoms and pain
Eligibility
Minimum age: 20 Years.
Maximum age: 79 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Hokkaido, Japan
Kanto, Japan
Chubu, Japan
Kinki, Japan
Kyusyu, Japan
Additional Information
Starting date: August 2007
Ending date: September 2008
Last updated: June 4, 2008
|
