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Dose-finding Study of ASP2151 in Subjects With Herpes Zoster

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00487682
First received: June 15, 2007
Last updated: December 19, 2011
Last verified: December 2011
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Shingles
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of cutaneous symptoms and pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00487682     History of Changes
Other Study ID Numbers: 15L-CL-221
Study First Received: June 15, 2007
Last Updated: December 19, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013