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Completed

NCT Number: NCT00487682

Dose-finding Study of ASP2151 in Subjects With Herpes Zoster

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.

Completed

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Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chūbu, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASP2151

Drug

oral

Valacyclovir Hydrochloride

Drug

oral

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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Dose-finding Study of ASP2151 in Subjects With Herpes Zoster- A Multicenter, Randomized, Double-blind, Valacyclovir Hydrochloride-controlled, Parallel-group, Comparative Study

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 18, 2007
Registry last updated
Nov 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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