NCT00448422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
Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)1 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2006年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 268
- 试验地点
- 1
- 主要终点
- Time to Last Unformed Stool (TLUS)
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 patients with acute bacterial gastroenteritis (traveler's diarrhea.
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 other gastrointestinal-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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 an 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 acute gastroenteritis of >72 hours duration
- •Bloody Diarrhea
- •Concomitant antibacterial with activity against enteric bacterial pathogens
- •History of IBD
- •Unable/Unwilling to comply with study protocol
- •Greater than two doses of an antidiarrheal medication within 24 hours
- •> 2 doses of anti-diarrheal medication within 24 hours
- •Antimicrobial treatment within 30 days
研究组 & 干预措施
1
Experimental
Tablet
干预措施: prulifloxacin (Drug)
2
Placebo Comparator
Tablet
干预措施: prulifloxacin (Drug)
结局指标
主要结局
Time to Last Unformed Stool (TLUS)
时间窗: End of Therapy
次要结局
- Clinical cure based on relief of signs and symptoms(End of therapy/study)
- Microbiologic eradication rates(End of therapy/study)
研究者
研究点 (1)
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