JPRN-jRCT2080222885已完成2 期
An open-label, multicenter clinical trial to assess the safety and efficacy of three different doses of OPS-2071 in patients with bacterial enteritis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
研究概览
简要总结
In this trial, OPS-2071 at 50 mg, 100 mg, and 200 mg doses was safe and well tolerated in subjects with enteric infection. OPS-2071 at 100 mg dose was safe and well tolerated in subjects with CDI.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 19age old 至 <= 74age old（—）
- 性别
- All
入选标准
- •The patient provides written, informed consent before the clinical trial is initiated.
- •-The patient has distinctive symptoms and findings of bacterial enteritis
- •-The patient has bacterial enteritis with one or more of the following causative pathogens either proven or presumed: Clostridium difficile (C. difficile), Salmonella,Campylobacter, pathogenic E. coli, and other bacteria estimated to cause bacterial enteritis
- •-The patient and his/her partner are willing to take contraceptive measures from initiation of investigational medicinal products (IMPs) to 4 weeks after administration of IMPs.
排除标准
- •-The patient has severe or progressive underlying disease or complication, making it difficult to ensure safety in the study or proper efficacy assessment.
- •-The patient has a current diagnosis or history of convulsive disorders, such as convulsion and epilepsy.
- •-The patient has a severe hepatic dysfunction
- •-The patient has a severe cardiac dysfunction
- •-The patient has cardiac arrhythmia or congenital or sporadic long QTc syndrome. or the patient is treated with a drug reported to prolong QTc interval
- •-The patient has a moderate or severe renal dysfunction
- •-Women with confirmed or suspected pregnancy or breast-feeding women
- •-Patients judged to be ineligible by the investigator for any other reasons
研究者
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