NCT01959295

Phase III Study of ASP2151 in Herpes Simplex Patients

Phase III Study of ASP2151 in Herpes Simplex Patients - A Double-blind, Placebo-controlled Study -

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 468 (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 in patients with herpes simplex.

Detailed description

A double-blind, randomized, placebo-controlled, parallel-group study will be conducted to evaluate the efficacy and safety of ASP2151 in patients with herpes simplex (labial/facial herpes or recurrent genital herpes). The efficacy will be evaluated for the primary endpoint defined as, "the proportion of subjects achieving lesion healing by Day 8 of study treatment" to demonstrate the superiority of ASP2151 to placebo. The safety will be evaluated based on adverse events, laboratory tests, vital signs, and ECGs.

Conditions

• Herpes Simplex

Interventions

Type	Name	Description
DRUG	ASP2151	200 mg once daily
DRUG	ASP2151 placebo	once daily

Timeline

• Start date: 2013-08-01
• Primary completion: 2015-04-01
• Completion: 2015-04-27
• First posted: 2013-10-10
• Last updated: 2024-10-09
• Results posted: 2024-10-09

Locations

3 sites across 1 country: Japan