NCT00106509已完成3 期
A Randomized, Double-Blind Study of GT267-004 Versus Vancomycin, and GT267-004 Versus Metronidazole, in Patients With C.Difficile - Associated Diarrhea
Genzyme, a Sanofi Company140 个研究点 分布在 1 个国家目标入组 520 人开始时间: 2005年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 520
- 试验地点
- 140
- 主要终点
- Resolution of diarrhea
研究概览
简要总结
Approximately 520 patients will be entered into this study taking place throughout the US and Canada. This study aims to determine if an investigational drug is safe and effective for treating symptoms of C. difficile-associated diarrhea (CDAD) and lowering the risk of repeat episodes of CDAD. The investigational drug will be evaluated in comparison to current standard antibiotic treatment, so all patients will receive active medication. All study related care is provided including doctor visits, physical exams, laboratory tests and study medication. Total length of participation is approximately 6 weeks.
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
- Double
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
- •The presence of CDAD at the time of enrollment with no other likely etiology for the diarrhea
- •Less than or equal to 48 hours of treatment with metronidazole, vancomycin or other antibacterial therapy specific for CDAD
- •Baseline serum potassium > 3.0 mmol (meq)/L
- •Patient considered sufficiently stable clinically to likely complete a 6 week study period
排除标准
- 未提供
结局指标
主要结局
Resolution of diarrhea
次要结局
- Number of stools
- Treatment success
- Time to resolution of diarrhea
- Recurrence rate
- Average stool consistency
研究者
研究点 (140)
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