A Multicenter, Randomized, Double-blind Study to Compare the Efficacy and Safety of Patient-initiated Famciclovir 1000 mg b.i.d. x 1 Day to Valacyclovir 500 mg b.i.d. x 3 Days in Immunocompetent Adults With Recurrent Genital Herpes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,179
- 试验地点
- 52
- 主要终点
- Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions
研究概览
简要总结
This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).
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 (Participant, Investigator)
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
- •At least 18 years old
- •History of at least 4 recurrences of genital herpes in the preceding 12 months
- •Lesions located on the external genitalia or anogenital region
- •Willing to discontinue suppressive treatment
- •Documented positive herpes simplex virus (HSV)
- •General good health, and history of normal renal function
排除标准
- •Women of childbearing potential not using approved form of contraceptive
- •Pregnant or nursing women
- •History of hypersensitivity to famciclovir, valacyclovir, or acyclovir
- •Known to be immunosuppressed
- •Known to have renal dysfunction
- •Receiving anti-herpes therapy
- •Known to have other genital tract disorders
- •Known to have condition which could interfere with drug absorption
- •Additional protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Famciclovir
Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
干预措施: Famciclovir (Drug)
Famciclovir
Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
干预措施: Placebo matching valacyclovir (Drug)
Valacyclovir
Patients received Valacyclovir 500 mg capsule twice a day approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
干预措施: Valacyclovir (Drug)
Valacyclovir
Patients received Valacyclovir 500 mg capsule twice a day approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
干预措施: Placebo matching famciclovir (Drug)
结局指标
主要结局
Investigator-assessed Time to Healing of All Non-aborted Genital Herpes Lesions
时间窗: 72 hours after initiation of study medication up to Day 20
Time to healing of all non-aborted genital herpes lesions was defined as the time from the first dose of study drug taken no earlier than the recurrence of genital herpes to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of the lesions; erythema could have been present). Non-aborted lesions are lesions which underwent vesicle, ulcer/soft crust, and/or hard crust formation and required re-epithelialization for healing. The median time was estimated using Kaplan-Meier method by censoring missing values at the time of last clinical lesion observation.
次要结局
- Percentage of Participants With Aborted Genital Herpes Lesions(72 hours after initiation of study medication up to Day 20)
- Investigator-assessed Time to Healing of All (Non-aborted and Aborted) Genital Herpes Lesions(72 hours after initiation of study medication up to Day 20)
- Time to Resolution of Symptoms Associated With Recurrent Genital Herpes(72 hours after initiation of study medication up to Day 20)
- Number of Patients With a Second Recurrence of Genital Herpes(Up to 6 months after investigator assessed healing of first recurrence of genital herpes)
- Time to a Second Recurrence of Genital Herpes(Up to 6 months after investigator assessed healing of first recurrence of genital herpes)