NCT00219310已完成4 期
A Study to Determine the Safety and Efficacy of Famciclovir in the Episodic and Suppressive Treatment of Recurrent Genital Herpes (RGH). The Study Will Also Evaluate Quality of Life and Patient Satisfaction
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 试验地点
- 1
- 主要终点
- Time (days from randomizations) to first recurrence of symptoms of recurrent genital herpes confirmed by PCR.
研究概览
简要总结
This trial will assess whether RGH patients who have two recurrent episodes within a three month period would benefit from suppressive treatment and whether patients prefer episodic therapy or suppressive therapy for the treatment of their RGH.
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
- •• Patients who are immunocompetent and who have had 4 or more episodes of Recurrent Genital Herpes (RGH) in the last 12 months.
- •Patients with active HSV-2 or HSV-1 infection as confirmed by Polymerase Chain Reaction (PCR).
- •Patients with active symptoms (i.e., itching, burning, tingling, aching, tenderness, rash or pain) associated with a recurrent episode of genital herpes
排除标准
- •• Female patients who are pregnant or breast-feeding.
- •Current, history or suspicion of liver disease or kidney disease.
- •HIV infected (as confirmed by positive HIV serology).
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Time (days from randomizations) to first recurrence of symptoms of recurrent genital herpes confirmed by PCR.
次要结局
- Change in total score of the Recurrent Genital Herpes Quality of Life.
- Safety assessed by adverse events.
- Time to first recurrence of genital herpes.
- Number of genital herpes recurrences confirmed by PCR.
研究者
研究点 (1)
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