NCT00002132已完成不适用
Randomized, Controlled, Double-Blind Study of Itraconazole Oral Solution Versus Fluconazole Tablets for the Treatment of Esophageal Candidiasis.
Janssen Pharmaceuticals35 个研究点 分布在 1 个国家开始时间: 2001年8月31日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 35
研究概览
简要总结
To evaluate the safety and efficacy of itraconazole oral solution versus fluconazole tablets for the treatment of esophageal candidiasis in immunocompromised patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have:
- •Esophageal candidiasis.
- •Histological evidence of Candida spp. at baseline with confirmation by positive mycological culture.
- •HIV infection or other predisposing risk factor.
- •Life expectancy of at least 2 months.
排除标准
- •Co-existing Condition:
- •Patients with the following symptoms or conditions are excluded:
- •Malignancies of the head or neck, if the treatment or disease will interfere with response assessment.
- •Evidence of systemic fungal infection.
- •Underlying clinical condition that would preclude study completion.
- •Judged to be unreliable in regard to following physician's directives.
- •Concurrent Medication:
- •Rifampin.
- •Rifabutin.
- •Phenobarbital.
- •Phenytoin.
- •Carbamazepine.
- •Terfenadine.
- •Astemizole.
- •H2 blockers.
- •Continual antacids.
- •Any investigational drug (expanded access drugs are allowed).
- •Patients with the following prior conditions are excluded:
- •History of significant hepatic abnormalities or clinical evidence of hepatic disease within 2 months prior to study entry.
- •History of hypersensitivity to imidazole or azole compounds.
- •Prior Medication:
- •Other orally administered antifungal therapy within 3 days prior to study entry.
- •Any investigational drug within 1 month prior to study entry (expanded access drugs are allowed).
研究者
研究点 (35)
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