Recruitment

Recruitment Status
Completed
Estimated Enrollment
750

Summary

Conditions
Herpes Zoster
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Min Age
20
Max Age
79
Gender
Both

Description

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 ...

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.

Locations

Nakano-Ku, Tokyo
Sapporo, Hokkaido
Yokohama, Kanagawa
Nakano-Ku, Tokyo
Sapporo, Hokkaido
Yokohama, Kanagawa

Tracking Information

NCT #
NCT01959841
Collaborators
Not Provided
Investigators
Study Director: Maruho Co.,Ltd. Kyoto R&D Center Clinical Development Department