Conditions: Herpes Simplex
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 468
Healthy volunteers: no

Brief 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.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: ASP2151 intervention 2: ASP2151 placebo
Intervention descriptions: intervention 1: 200 mg once daily intervention 2: once daily

Protocol document: