A Randomized, Double-blind, Parallel Group, Placebo-controlled, Multi-center, Therapeutic Equivalence Study to Compare Rifaximin 200 mg Tablets (Sandoz GmbH) to Xifaxan® 200 mg Tablets (Salix Pharmaceuticals, Inc.) and Placebo in Patients With Travelers' Diarrhea
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Sandoz
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Clinical Cure Rate
研究概览
简要总结
This study compared safety and efficacy of a generic rifaximin tablet to the reference listed drug in the treatment of travelers' diarrhea. Additionally both the generic and reference formulations were tested for superiority against a placebo tablet.
It was planned that 450 patients would be enrolled, but only 28 patients were randomized. Of these, 1 patient discontinued due to failure to meet the inclusion/exclusion criteria. The remaining 27 patients received study drug and 25 patients completed the study.
The study was terminated due to slow enrolment. The final analysis included only safety analysis in the Safety population, due to the low number of randomized patients. No efficacy analysis was performed.
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
- •Patient is able to read and understood the language of the Informed Consent Form and Patient Information.
- •International travelers with a duration of stay in host country long enough to attend schedules visits.
- •Affected by naturally acquired acute diarrhea, defined as the passage of at least 3 unformed stools within 24 hours immediately preceding randomization preceding randomization
排除标准
- •Hypersensitivity to rifaximin or any of the rifamycin antimicrobial agents or to any of the excipients of the study drug.
- •Pregnant, breast feeding or planning pregnancy
- •Acute diarrhea for > 72 hours immediately prior to randomization.
- •Presence of fever (≥ 100 °F/37.8°C) or hematochezia (blood in stool, noted visually) or clinical findings suggesting moderate or severe dehydration.
研究组 & 干预措施
Rifaximin
Patients received Rifaximin 200 mg tablet 3 times per day for 3 days.
干预措施: Rifaximin (Sandoz GmbH) tablet (Drug)
Xifaxan
Patients received Xifaxan 200 mg tablet 3 times per day for 3 days.
干预措施: Rifaximin (Xifaxan) (Drug)
Placebo
Patients received placebo tablet 3 times per day for 3 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Clinical Cure Rate
时间窗: study day 5 +/- 1 day
Clinical cure was defined as either no stools or only formed stools within a 48 hour period and no fever, with or without other enteric symptoms, OR no watery stools or no more than two soft stools passed within a 24 hour period with no fever and no other enteric symptoms except for mild excess gas/flatulence.
次要结局
- Number of Unformed Stools(within 5 study days)
- Proportion of Patients With Improvement of Diarrheal Syndrome(within 5 study days)
- Microbiological Cure Rate(study day 5)
- Time to Last Unformed Stool(within 5 study days)
- The Presence or Absence and Severity of Signs and Symptoms of Enteric Infection(within 5 study days)
- Proportion of Patients With Clinical Failure(within 5 study days)