Dose-finding Study of ASP2151 in Subjects With Herpes Zoster

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

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.

Study Overview

• Status: Completed
• Conditions: Herpes Zoster
• Intervention / Treatment: Drug: ASP2151; Drug: Valacyclovir hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 403
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Chubu, Japan
  • Hokkaido, Japan
  • Kanto, Japan
  • Kinki, Japan
  • Kyusyu, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Valacyclovir hydrochloride	Drug: Valacyclovir hydrochloride; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To compare the efficacy and safety of ASP2151 with valacyclovir in subjects with Herpes Zoster	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Improvement of cutaneous symptoms and pain	3 months

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc

Publications and helpful links

Helpful Links

• Link to results on the Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2007
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: June 15, 2007
• First Submitted That Met QC Criteria: June 15, 2007
• First Posted (Estimate): June 18, 2007

Study Record Updates

• Last Update Posted (Actual): November 23, 2018
• Last Update Submitted That Met QC Criteria: November 20, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: herpes zoster; Valacyclovir hydrochloride; ASP2151
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster; Herpes Simplex; Anti-Infective Agents; Antiviral Agents; Valacyclovir
• Other Study ID Numbers: 15L-CL-221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."