NCT00199264终止2 期
A Single-Blind, Randomized, Dose-Finding Study Versus Fluconazole to Assess the Efficacy and Tolerability of Five Single Doses of Albaconazole in the Treatment of Acute Non-Recurrent Candida Spp Vulvovaginitis
J. Uriach and Company0 个研究点目标入组 60 人开始时间: 2004年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 60
- 主要终点
- Primary Efficacy VariableThe primary efficacy assessment will be carried out 24 ± 4 (FV) days following treatment or at the last patient's.
研究概览
简要总结
To compare the therapeutic efficacy of 10 mg, 40 mg, 80 mg, 160 mg and 320 mg of albaconazole, as a single oral dose, in women affected by acute non-complicated vulvovaginitis due to Candida spp.
详细描述
Multi-center, open-label, randomized study, controlled with fluconazole.
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
- •Ambulatory patients over 18 years of age, with a vaginal score sum ³ 2 and KOH fresh examination positive for yeasts (hyphae, pseudohyphae). The diagnosis must be later confirmed with a positive Candida spp. culture.
排除标准
- •Patients with recurrent disease, prior treatment with antifungal agents within the last 7 days, immunosuppression, pregnant or lactating women, other vulvovaginal diseases, other systemic diseases, hypersensitivity to azole derivatives.Number of patients: 78 patients included to obtain 60 evaluable patients
结局指标
主要结局
Primary Efficacy VariableThe primary efficacy assessment will be carried out 24 ± 4 (FV) days following treatment or at the last patient's.
次要结局
未报告次要终点
研究者
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