A Prospective, Randomized, Multicenter Study of the Efficacy and Safety of Famciclovir 500 mg Comparing To Aciclovir 400mg in Patients With Herpes Zoster
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 177
- 试验地点
- 5
- 主要终点
- For efficacy evaluation, a visual analogue scale (VAS) will be used to detect the improvement of symptoms
研究概览
简要总结
Herpes Zoster is an infection that affects part of the nervous system caused by Varicella Zoster Virus. Herpes Zoster manifests as vesicular eruption in the dermatome, often associated with significant pain.
There are effective oral prescription antiviral medicines available to reduce the discomfort of symptoms as famciclovir and aciclovir.
This is a phase III, multicenter, randomized, parallel-group study to compare the efficacy and safety of treatment with Famciclovir (500 mg) comparing to Aciclovir (400 mg) in patients with Herpes Zoster.
详细描述
Study Design
- single blind study, prospective, parallel group, intent to treat trial
- Experiment duration: 7 days
- 2 visits (days 0, and 7)
- 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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be able to understand the study procedures, agree to participate and give written consent.
- •Patients with clinical diagnosis of Herpes Zoster;
- •Score higher than 4 for at least for 2 symptoms of Herpes Zoster;
- •Negative pregnant urine test
排除标准
- •Pregnancy or risk of pregnancy.
- •Lactation
- •Any pathology or past medical condition that can interfere with this protocol.
- •Non-steroidal anti-inflammatory drug , hormonal anti-inflammatory or immunosuppressive drugs (in the last 30 days and during the study);
- •Patients with immunodeficiency and/or immunosuppressive disease;
- •Hypersensitivity to components of the formula;
- •Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation.
研究组 & 干预措施
Famciclovir 500mg
1 tablet each 8 hours for 7 days
干预措施: Famciclovir (Drug)
Aciclovir 400mg
2 tablets of Aciclovir 400 mg each 4 hours for 7 days
干预措施: Aciclovir (Drug)
结局指标
主要结局
For efficacy evaluation, a visual analogue scale (VAS) will be used to detect the improvement of symptoms
时间窗: day 7
Symptoms evaluated: pain, injury, loss of sensation, burning and itching
次要结局
- Safety will be evaluated by the adverse events occurrences(day 7)