Dose-finding Study of ASP2151 in Subjects With Herpes Zoster

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

403 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-13

Study Completion Date

2008-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Herpes Zoster

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

ASP2151 low dose

Group Type EXPERIMENTAL

ASP2151

Intervention Type DRUG

oral

2

ASP2151 middle dose

Group Type EXPERIMENTAL

ASP2151

Intervention Type DRUG

oral

3

ASP2151 high dose

Group Type EXPERIMENTAL

ASP2151

Intervention Type DRUG

oral

4

Valacyclovir hydrochloride

Group Type ACTIVE_COMPARATOR

Valacyclovir hydrochloride

Intervention Type DRUG

oral

Interventions

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ASP2151

oral

Intervention Type DRUG

Valacyclovir hydrochloride

oral

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No