A Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Famciclovir 125 mg Comparing to Aciclovir 200 mg in Patients With Active Recurrent Genital Herpes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 9
- 主要终点
- Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation
研究概览
简要总结
Recurrent genital herpes is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are effective oral prescription antiviral medicines available to reduce the discomfort of symptoms, such as famciclovir and aciclovir.
This is a phase III, multicenter, randomized, parallel-group study to compare the efficacy and safety of treatment with famciclovir (125 mg) versus aciclovir (200 mg) in patients with active recurrent genital herpes.
详细描述
STUDY DESIGN
- Open-label, prospective, parallel group, intent to treat trial
- Experiment duration: 5 days
- 2 visits (days 1, and 5)
- Reduction of symptoms
- Adverse events evaluation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Famciclovir 125 mg
1 tablet every 12 hours for 5 days
干预措施: Famciclovir (Drug)
Aciclovir 200 mg
1 tablet every 4 hours (excluding nocturnal dose) for 5 days
干预措施: Aciclovir (Drug)
结局指标
主要结局
Efficacy Will be Evaluated by the Proportion of Subjects With Non Herpes Manifestation
时间窗: Day 5
Symptoms evaluated: erythema, papule, vesicle, ulcer, crust, or healed skin.
次要结局
- Safety Will be Evaluated by the Adverse Events Occurence(Day 5)