Dose-finding Study of ASP2151 in Subjects With Herpes Zoster

Astellas

Status and phase: Completed; Phase 2

Conditions: Herpes Zoster

Treatments: Drug: ASP2151; Drug: Valacyclovir hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00487682

15L-CL-221

Details and patient eligibility

About

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.

Enrollment: 403 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

403 participants in 4 patient groups

1

Experimental group

Description:

ASP2151 low dose

Treatment:

Drug: ASP2151

2

Experimental group

Description:

ASP2151 middle dose

Treatment:

Drug: ASP2151

3

Experimental group

Description:

ASP2151 high dose

Treatment:

Drug: ASP2151

4

Active Comparator group

Description:

Valacyclovir hydrochloride

Treatment:

Drug: Valacyclovir hydrochloride