NCT00382304已完成2 期
A Study of the Pharmacokinetics of GT267-004 in Patients With Clostridium Difficile-Associated Diarrhea
Genzyme, a Sanofi Company8 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2006年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 8
- 主要终点
- The extent of GT267-004 absorption as measured in the blood and urine by pharmacokinetic analysis
研究概览
简要总结
Approximately 24 patients will be entered into this study taking place in Canada. The aim of this study is to determine if an investigational drug is absorbed (taken up) in patients with C. difficile-associated diarrhea (CDAD). The investigational drug will be given in addition to current standard antibiotic treatment so that all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests, and study medication. The total length of participation is approximately 7 days.
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
- •18 years of age or older
- •The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea
排除标准
- •> 72 hours of treatment with metronidazole, vancomycin, or other antibacterial therapy specifically targeting the current acute episode of CDAD
- •Patient not considered sufficiently stable clinically to complete the study period
结局指标
主要结局
The extent of GT267-004 absorption as measured in the blood and urine by pharmacokinetic analysis
次要结局
- Safety as measured by physical examinations (including vital signs), adverse events and changes in safety laboratory values
研究者
研究点 (8)
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