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NCT00487682 Clinical Trial

Dose-finding Study of ASP2151 in Subjects With Herpes Zoster

Herpes Zoster Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00487682
Other study ID # 15L-CL-221
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date November 13, 2007
Est. completion date September 1, 2008

Study information
Verified date November 2018
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 403
Est. completion date September 1, 2008
Est. primary completion date September 1, 2008
Accepts healthy volunteers No
Gender All
Age group 20 Years to 79 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• ASP2151
oral
• Valacyclovir hydrochloride
oral

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary To compare the efficacy and safety of ASP2151 with valacyclovir in subjects with Herpes Zoster 3 months
Secondary Improvement of cutaneous symptoms and pain 3 months
See also
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Active, not recruiting NCT04091451 - A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) Who Had Prior Episode of Shingles Phase 3
Completed NCT02519855 - Study to Evaluate Immunogenicity, Safety, and Tolerability of ZOSTAVAX™ Vaccine (Zoster Vaccine Live, V211) Administered Concomitantly Versus Nonconcomitantly With Quadrivalent Influenza Virus Vaccine (Inactivated) in Participants ≥50 Years of Age (V211-062) Phase 3
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Completed NCT01527370 - Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025) Phase 3
Completed NCT01954251 - Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With GSK Biologicals' Seasonal Influenza Vaccine GSK2321138A in Adults Aged 50 Years and Older Phase 3

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