NCT01959841

Phase III Study of ASP2151 in Herpes Zoster Patients

Phase III Study of ASP2151 in Herpes Zoster Patients- A Double-blind, Valaciclovir-controlled Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 751 (actual)
• Sponsor: Maruho Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 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.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
DRUG	ASP2151	200 mg once daily or 400 mg once daily
DRUG	valaciclovir	1000 mg three times daily

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-07-01
• Completion: 2015-07-10
• First posted: 2013-10-10
• Last updated: 2018-11-27
• Results posted: 2018-10-18

Locations

3 sites across 1 country: Japan