NCT00171990已完成3 期
Efficacy and Safety of Oral Famciclovir in Patients With Active Recurrent Genital Herpes
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 1,461
- 试验地点
- 1
- 主要终点
- Estimated probability being not lesion-free(i.e. not healed) 5.5 elapsed days (132 hours) after patient self-initiation therapy.
研究概览
简要总结
This is a phase III, multicenter, randomized, double-blind, parallel-group study to compare the efficacy and safety of a two-day treatment with famciclovir (500 mg loading dose followed by 250 mg 12-hourly) to standard five-day treatment with famciclovir (125 mg 12-hourly) in patients with active recurrent genital herpes.
This study is not recruiting patients in the United States.
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
- Double
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
- •Diagnosis of genital herpes
- •Had at least 2 recurrences in past 12 months or 1 recurrence in past 6 months
排除标准
- •- Currently taking suppressive herpes antiviral therapy
- •Females who are pregnant, breast feeding or planning to become pregnant during study
- •History of allergy to famciclovir or similar products (e.g. aciclovir, valaciclovir)
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Estimated probability being not lesion-free(i.e. not healed) 5.5 elapsed days (132 hours) after patient self-initiation therapy.
次要结局
- Time between recurrences of genital herpes.
- Proportion of aborted (i.e. lesions did not appear)genital herpes recurrences. Change from baseline in symptoms or impairment. Change form baseline in functioning or disability.
- Safety and tolerability assessed by AEs.
研究者
研究点 (1)
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