Dose-finding Study of ASP2151 in Subjects With Herpes Zoster

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00487682
Recruitment Status : Completed
First Posted : June 18, 2007
Last Update Posted : December 21, 2011
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Herpes Zoster Drug: ASP2151 Drug: Valacyclovir hydrochloride Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 403 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
ASP2151 low dose
Drug: ASP2151
Experimental: 2
ASP2151 middle dose
Drug: ASP2151
Experimental: 3
ASP2151 high dose
Drug: ASP2151
Active Comparator: 4 Drug: Valacyclovir hydrochloride

Primary Outcome Measures :
  1. To compare the efficacy and safety of ASP2151 with valacyclovir in subjects with Herpes Zoster [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Improvement of cutaneous symptoms and pain [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00487682

Chubu, Japan
Hokkaido, Japan
Kanto, Japan
Kinki, Japan
Kyusyu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Study Chair: Use Central Contact Astellas Pharma Inc

Responsible Party: Astellas Pharma Inc Identifier: NCT00487682     History of Changes
Other Study ID Numbers: 15L-CL-221
First Posted: June 18, 2007    Key Record Dates
Last Update Posted: December 21, 2011
Last Verified: December 2011

Keywords provided by Astellas Pharma Inc:
herpes zoster
Valacyclovir hydrochloride

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Antiviral Agents
Anti-Infective Agents