Dose-finding Study of ASP2151 in Subjects With Herpes Zoster

NCT00487682 | Completed Phase 2

• 1 other identifier: 15L-CL-221
• Study Type: interventional
• Target: 403
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Herpes Zoster

Keywords

Valacyclovir hydrochloride; herpes zoster; ASP2151

Outcome Measures

Primary Outcomes (1)

• To compare the efficacy and safety of ASP2151 with valacyclovir in subjects with Herpes Zoster

  3 months

Secondary Outcomes (1)

• Improvement of cutaneous symptoms and pain

  3 months

Study Arms (4)

1

EXPERIMENTAL

ASP2151 low dose

Drug: ASP2151

2

EXPERIMENTAL

ASP2151 middle dose

Drug: ASP2151

3

EXPERIMENTAL

ASP2151 high dose

Drug: ASP2151

4

ACTIVE COMPARATOR

Valacyclovir hydrochloride

Drug: Valacyclovir hydrochloride

Interventions

ASP2151 DRUG

oral

1; 2; 3

Valacyclovir hydrochloride DRUG

oral

4

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (5)

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kanto, Japan

Location

Unknown Facility

Kinki, Japan

Location

Unknown Facility

Kyusyu, Japan

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Conditions

Herpes Zoster

Interventions

ASP2151; Valacyclovir

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2007
• First Posted: June 18, 2007
• Study Start: November 13, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: November 23, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

JP (5)