Back to resultsDose-finding Study of ASP2151 in Subjects With Herpes Zoster
Primary Purpose
Herpes Zoster
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
ASP2151
Valacyclovir hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Herpes Zoster focused on measuring Valacyclovir hydrochloride, herpes zoster, ASP2151
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
4
Arm Description
ASP2151 low dose
ASP2151 middle dose
ASP2151 high dose
Valacyclovir hydrochloride
Outcomes
Primary Outcome Measures
To compare the efficacy and safety of ASP2151 with valacyclovir in subjects with Herpes Zoster
Secondary Outcome Measures
Improvement of cutaneous symptoms and pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00487682
Brief Title
Dose-finding Study of ASP2151 in Subjects With Herpes Zoster
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 Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
November 13, 2007 (Actual)
Primary Completion Date
September 1, 2008 (Actual)
Study Completion Date
September 1, 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Zoster
Keywords
Valacyclovir hydrochloride, herpes zoster, ASP2151
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
403 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
ASP2151 low dose
Arm Title
2
Arm Type
Experimental
Arm Description
ASP2151 middle dose
Arm Title
3
Arm Type
Experimental
Arm Description
ASP2151 high dose
Arm Title
4
Arm Type
Active Comparator
Arm Description
Valacyclovir hydrochloride
Intervention Type
Drug
Intervention Name(s)
ASP2151
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
Valacyclovir hydrochloride
Intervention Description
oral
Primary Outcome Measure Information:
Title
To compare the efficacy and safety of ASP2151 with valacyclovir in subjects with Herpes Zoster
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Improvement of cutaneous symptoms and pain
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Chubu
Country
Japan
City
Hokkaido
Country
Japan
City
Kanto
Country
Japan
City
Kinki
Country
Japan
City
Kyusyu
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=232
Description
Link to results on the Astellas Clinical Study Results website
Learn more about this trial
Dose-finding Study of ASP2151 in Subjects With Herpes Zoster
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