NCT00477334已完成4 期
A Randomized, Multicenter, Double-blind Study to Compare the Efficacy of Single-day Treatment (1000 mg b.i.d.) With Famciclovir Compared to That of Placebo in Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Immunocompetent Black Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 463
- 试验地点
- 43
- 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 evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes
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
- •Black men or women 18 years or older
- •History of recurrent genital herpes with at least 4 recurrences in preceding 12 months or in preceding 12 months prior to using suppressive antiviral therapy
- •Documented herpes simplex virus type 2 (HSV-2) seropositivity
- •Willingness to discontinue suppressive therapy during study, if applicable
- •Willingness and ability to comply with the study protocol
排除标准
- •Pregnant or breastfeeding women
- •Women of childbearing potential not using accepted methods of contraception
- •Hypersensitivity to famciclovir or drugs with similar chemical structures
- •Renal dysfunction
- •Known or suspected to have decompensated liver disease
- •Known to have gastrointestinal malabsorption
- •Known to be immunocompromised
- •Known to be hypersensitive to ingredients in study medication
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
1
Experimental
Famciclovir 1000 mg; twice a day for one day.
干预措施: Famciclovir (Drug)
2
Placebo Comparator
Placebo; twice a day for one day.
干预措施: Placebo (Drug)
结局指标
主要结局
Investigator Assessed Time to Healing of All Non-aborted Genital Herpes Lesions
时间窗: 21 days
Time to healing of all non-aborted genital herpes lesions, defined as the time from the first dose of study medication to the investigator-assessed time of healing (i.e. loss of all crusts and re-epithelialization of lesions; erythema may be present).
次要结局
- Percentage of Participants With Aborted and Non-aborted Genital Herpes Lesions During the Treatment Period(21 days)
- Investigator Assessed Time to Healing of All Non-aborted and Aborted Genital Herpes Lesions(21 days)
- Time to Resolution of Symptoms Associated With Recurrent Genital Herpes(72 hour after initiation of study medication up to 21 days)
- Number of Participants With a Second Recurrence of Genital Herpes in the Follow-up Period(6 months)
- Time to Second Recurrence of Genital Herpes(6 months)
- The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Hematology Test and Treatment(Baseline, Day 2)
- The Number of Participants With Clinically Notable Shifts From Normal at Baseline by Chemistry Test and Treatment(Baseline, Day 2)
研究者
研究点 (43)
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