Dose-finding Study of ASP2151 in Subjects With Herpes Zoster - Full Text View

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00487682

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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

Drug Information available for: Valaciclovir Valacyclovir hydrochloride

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
1: Experimental ASP2151 low dose	Drug: ASP2151 oral
2: Experimental ASP2151 middle dose	Drug: ASP2151 oral
3: Experimental ASP2151 high dose	Drug: ASP2151 oral
4: Active Comparator	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

Hokkaido, Japan

Kanto, Japan

Chubu, 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 ( Director )
Study ID Numbers:	15L-CL-221
Study First Received:	June 15, 2007
Last Updated:	January 4, 2010
ClinicalTrials.gov Identifier:	NCT00487682 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Astellas Pharma Inc:

herpes zoster
ASP2151
Valacyclovir hydrochloride

Additional relevant MeSH terms:

Valacyclovir
Virus Diseases
Herpes Zoster
Anti-Infective Agents
Acyclovir

Therapeutic Uses
DNA Virus Infections
Antiviral Agents
Pharmacologic Actions
Herpesviridae Infections

ClinicalTrials.gov processed this record on February 08, 2010