NCT00392574已完成3 期
A Multicenter, Double-Blind, Randomized Study to Compare The Safety and Efficacy of Prulifloxacin Versus Placebo in the Treatment of Acute Gastroenteritis in Adult Travelers
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- Time to last unformed stool
研究概览
简要总结
The objective of this pivotal Phase III study is to investigate the safety and efficacy of prulifloxacin versus placebo in the treatment of subjects with acute bacterial gastroenteritis.
详细描述
This double-blind trial will compare the safety and efficacy of prulifloxacin versus placebo in adult travelers with acute gastroenteritis characterized by diarrhea with one or more of the following signs or symptoms: nausea, vomiting, abdominal pain or cramping, fecal urgency, moderate to severe gas-related symptoms, or tenesmus of ≤72 hours duration.
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 (Participant, Investigator)
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
- •Diagnosis of Acute Bacterial Gastroenteritis;
- •Traveler from Industrialized Country;
- •Capable of giving Informed Consent
排除标准
- •Fever (>100.3 degrees);
- •Pregnant or Breast Feeding or Not using adequate birth control;
- •Known or Suspected (co-)Infection with non-bacterial pathogen;
- •Symptoms of Gastroenteritis of >72 hours;
- •Bloody Diarrhea;
- •Concomitant antibacterial with activity against enteric bacterial pathogens;
- •History of IBD;
- •Unable/Unwilling to comply with study protocol;
- •> 2 doses of anti-diarrheal medication within 24 hours;
- •Antimicrobial Treatment within 30 days
研究组 & 干预措施
1
Experimental
Prulifloxacin
干预措施: Prulifloxacin (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to last unformed stool
时间窗: Study days 1-3
次要结局
- Clinical cure based on relief of signs and symptoms(Study days 1-3)
- Microbiologic eradication rates(Study days 1-3)
研究者
研究点 (1)
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