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CompletedNCT00487682Updated Nov 23, 2018

Dose-finding Study of ASP2151 in Subjects With Herpes Zoster

A Phase 2 interventional study of ASP2151 and Valacyclovir hydrochloride in Herpes Zoster, sponsored by Astellas Pharma Inc. Completed at 5 sites in Japan. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2018-11-23.

Sponsored by Astellas Pharma Inc · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
403
Allocation
Randomized
Ages
20 Years to 79 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Herpes Zoster

Keywords

  • Valacyclovir hydrochloride
  • herpes zoster
  • ASP2151
03

In context

Herpes Simplex

305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.

This study's enrollment of 403 is above the median of 101 across 227 interventional studies indexed under Herpes Simplex.

Browse Herpes Simplex studies →

Lead sponsor

Astellas Pharma Inc is the lead sponsor of 512 studies on the registry; 4 are open to participants now.

Of its 27 completed or terminated interventional studies of FDA-regulated products, 19 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
403 participants (actual)

Study arms

  • Experimental
    1

    ASP2151 low dose

    Drug: ASP2151

  • Experimental
    2

    ASP2151 middle dose

    Drug: ASP2151

  • Experimental
    3

    ASP2151 high dose

    Drug: ASP2151

  • Active comparator
    4

    Valacyclovir hydrochloride

    Drug: Valacyclovir hydrochloride

Interventions

  • DrugASP2151

    oral

  • DrugValacyclovir hydrochloride

    oral

06

What researchers measure

Primary outcomes

  1. To compare the efficacy and safety of ASP2151 with valacyclovir in subjects with Herpes Zoster

    Time frame: 3 months

Secondary outcomes

  1. Improvement of cutaneous symptoms and pain

    Time frame: 3 months

07

Study locations

5 sites
  • Chubu, Japan
  • Hokkaido, Japan
  • Kanto, Japan
  • Kinki, Japan
  • Kyusyu, Japan
08

References and documents

Individual participant data

Plan to share: No — 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."

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00487682
Lead sponsor
Astellas Pharma Inc
Responsible party
Sponsor
First posted
Jun 18, 2007
Start date
Nov 13, 2007
Primary completion
Sep 1, 2008
Completion
Sep 1, 2008
Last update
Nov 23, 2018

Study contacts

Use Central Contact
study chair · Astellas Pharma Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

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