Phase III Study of ASP2151 in Herpes Zoster Patients

Phase 3CompletedNCT01959841

Maruho Co., Ltd.751 enrolled

Overview

To evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in patients with herpes zoster.

A double-blind, randomized, parallel-group study will be conducted to evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in patients with herpes zoster. The efficacy will be evaluated for the primary endpoint defined as, "the proportion of subjects achieving cessation of new lesion formation by Day 4 of study treatment" to demonstrate the non-inferiority of ASP2151 to VACV. The safety will be evaluated based on adverse events, laboratory tests, vital signs, and ECGs.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

751

Conditions

Herpes Zoster

Interventions

ASP2151DRUG

200 mg once daily or 400 mg once daily

valaciclovirDRUG

1000 mg three times daily

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 Years

Medical Language ↔ Plain English

Inclusion Criteria: (1) Patients who have a rash associated with herpes zoster, and who can start receiving the study drug within 72 hours after onset of the rash Exclusion Criteria: 1. Patients who are not expected to have an adequate response to oral antiviral medication 2. An extreme decline in immune function 3. Presence of serious complications 4. Patients found to meet any of the following conditions based on laboratory tests performed within 14 days before informed consent: * AST or ALT ≥ 2.5 x upper limit of normal * Platelet count \< lower limit of normal * Serum creatinine ≥ 1.5 mg/dL * Creatinine clearance \< 50 mL/min 5. Current or previous history of malignant tumor within 5 years before informed consent 6. Diagnosis of autoimmune disease 7. Evidence of bone marrow suppression

Locations (3)

Unnamed facility

Sapporo, Hokkaido, Japan

Unnamed facility

Yokohama, Kanagawa, Japan

Unnamed facility

Nakano-Ku, Tokyo, Japan

Outcomes

Primary Outcomes

The Percentage of Participants Achieving Cessation of New Lesion Formation by Day 4 of Study Treatment

The investigator assessed the Number of rashes (erythemas/papulae and vesicles/pustules). The "new lesion formation" was defined as the state in which the number of rashes is increasing.

Time frame: 4days

Secondary Outcomes

Time to Cessation of New Lesion Formation

The investigator assessed the Number of rashes (erythemas/papulae and vesicles/pustules). The "new lesion formation" was defined as the state in which the number of rashes is increasing.

Time frame: 29days

Time to Complete Crusting

We defined the following state as "Complete crusting". 1. A condition where all lesions of erythemas/papulae, vesicles/pustules, and erosions/ulcers have disappeared, and all rashes are crusted (epithelialization of the base of crusts is not required). 2. In subjects with no formation of vesicles or pustules, a condition where all lesions of erythemas/papulae have disappeared.

Time frame: 29days

Time to Healing

We defined the following state as "Healing". 1. A condition where all lesions of erythemas/papulae, vesicles/pustules, and erosions/ulcers have disappeared, and complete disappearance of crusts or complete epithelialization of the base of crusts are considered to have been achieved. 2. In subjects with no formation of vesicles or pustules, a condition where all lesions of erythemas/papulae have disappeared

Time frame: 29days

Time to Pain Resolution

Investigators assessed the pain using NRS. The date of pain resolution is defined as the first day when all NRS scores are rated as 2 or less, and such scores are continuously observed until Day 92 or discontinuation visit.

Time frame: 29days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.