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Dose-finding Study of ASP2151 in Subjects With Herpes Zoster

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00487682
First Posted: June 18, 2007
Last Update Posted: December 21, 2011
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.
Information provided by (Responsible Party):
Astellas Pharma Inc
  Purpose
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 Intervention Phase
Herpes Zoster Drug: ASP2151 Drug: Valacyclovir hydrochloride Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

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

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

Enrollment: 403
Study Start Date: August 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ASP2151 low dose
Drug: ASP2151
oral
Experimental: 2
ASP2151 middle dose
Drug: ASP2151
oral
Experimental: 3
ASP2151 high dose
Drug: ASP2151
oral
Active Comparator: 4 Drug: Valacyclovir hydrochloride
oral

  Eligibility

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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00487682


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

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

Keywords provided by Astellas Pharma Inc:
herpes zoster
ASP2151
Valacyclovir hydrochloride

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