A Multicenter, Randomized, Double-Blind, Parallel-Group, Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic Neuralgia and Treatment of Acute Herpes Zoster Associated Pain
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 237
- 试验地点
- 1
- 主要终点
- The incidence of post-herpetic neuralgia(PHN) following treatment with 2 dose regimens of FV-100 compared to valacyclovir.
研究概览
简要总结
This is a multicenter, randomized, double-blind, parallel-group, active controlled comparative study of the safety and efficacy of 2 dosing regimens of FV-100 versus valacyclovir administered for 7 days in subjects with uncomplicated AHZ(acute herpes zoster).
详细描述
This is a multicenter, randomized, double-blind, parallel-group, active controlled comparative study of the safety and efficacy of 2 dosing regimens of FV-100 versus valacyclovir administered for 7 days in subjects with uncomplicated AHZ(acute herpes zoster). Subjects diagnosed with uncomplicated AHZ within 72 hours of lesion appearance and worst pain of 4 or greater at day 1, will be randomized (1:1:1) to one of three treatment groups and will begin study treatment at the Day 1 visit(within 72 hours of AHZ lesion appearance) to either: 1. FV-100 400mg QD, 2. FV-100 400mg BID(total daily dose of 800mg), or 3. Valacyclovir 1000mg 3 times a day for a total daily dose of 3000mg. Subjects will be monitored for adverse events through day 21. Efficacy assessments for lesion status and AHZ pain are captured til day 120.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receive a clinical diagnosis of uncomplicated AHZ as evidenced by a unilateral dermatomal rash
- •Have zoster-related pain
- •Are able to be randomized and receive their first dose within approximately 120 hours from appearance of rash
排除标准
- •Have multidermal or disseminated AHZ
- •Have facial, ophthalmologic or oral manifestations
- •Have received Zostavax
研究组 & 干预措施
FV-100 400 mg QD
FV-100 400mg QD
干预措施: FV-100 (Drug)
FV-100 400mg BID
FV-100 400mg BID(total daily dose of 800mg)
干预措施: FV-100 (Drug)
valacyclovir
valacyclovir 1000mg TID
干预措施: valacyclovir (Drug)
结局指标
主要结局
The incidence of post-herpetic neuralgia(PHN) following treatment with 2 dose regimens of FV-100 compared to valacyclovir.
时间窗: Day 1 to Day 120
efficacy measure
次要结局
- Acute herpes zoster associated pain, as measured by Zoster Brief Pain Inventory(ZBPI)(Day 1 to Day 120)
- The number and classification of adverse events in 2 dosing regimens of FV-100(Day 1 to Day 120)
- The pharmacokinetic profile of the active metabolite of FV-100 after 7 days of dosing at 400mg QD versus compared with 400mg BID(Day 1 to Day 120)
- The effect on lesion formation and healing of 2 dose regimens of FV-100 compared to valacyclovir(Day 1 to Day 120)