NCT00466635终止3 期
An Open-label Study to Assess the Safety, Efficacy and Absorption of Exodif™ (Tolevamer Potassium Sodium) Tablets in Patients With Clostridium Difficile-Associated Diarrhea
Genzyme, a Sanofi Company13 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2007年4月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 65
- 试验地点
- 13
- 主要终点
- Safety
研究概览
简要总结
Approximately 65 patients will be entered into this study taking place in North America. The aim of this study is to evaluate the safety, efficacy and absorption of an investigational drug in patients with C. difficile-associated diarrhea (CDAD). All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is 6 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •The presence of CDAD at the time of enrollment
- •Negative serum pregnancy test (HCG) for women of childbearing potential.
排除标准
- •Any contraindication to oral / enteral therapy including fulminant C. difficile disease.
- •Any acutely life-threatening medical conditions.
- •Acute or chronic diarrhea of other cause.
结局指标
主要结局
Safety
Clinical Success
次要结局
- The extent of tolevamer absorption
研究者
研究点 (13)
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