A Clinical Trial to Assess 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
- 主要终点
- Maximum Plasma Concentration (Cmax) of OPS-2071 on Day 4
研究概览
简要总结
To assess safety, efficacy and pharmacokinetics of multiple dosesin patients with Bacterial Enteritis caused by Clostridium difficile infection(CDI) or Enteric infection.
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
- None
入排标准
- 年龄范围
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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: 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
研究组 & 干预措施
OPS-2071 50mg/day
OPS-2071 50 mg/day：25 mg tablet administered orally twice daily
干预措施: OPS-2071 tablet (Drug)
OPS-2071 100 mg/day
OPS-2071 100 mg/day：50 mg tablet administered orally twice daily
干预措施: OPS-2071 tablet (Drug)
OPS-2071 200 mg/day
OPS-2071 200 mg/day：100 mg tablet administered orally twice daily
干预措施: OPS-2071 tablet (Drug)
OPS-2071 400 mg/day
OPS-2071 400 mg/day：100 mg two tablets administered orally twice daily
干预措施: OPS-2071 tablet (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of OPS-2071 on Day 4
时间窗: Inpatient: 1h, 2h, and 4h after morning administration
We measured OPS-2071 concentration in plasma and evaluated Cmax of OPS-2071 in plasma.
Bacterial Elimination Rate (BER) in the CDI and EI Groups
时间窗: CDI group: screening, Day 4 and Day 11 (end of treatment), EI group: screening, Day 4 and Day 8 (end of treatment)
Judged according to the assessment criteria for the bacterial strain isolated as the causative pathogen based on the data from the microbiological examination. Analysis was performed by disease group and by dose, and by minimum inhibitory concentration (MIC) values of OPS-2071 for each of the causative strains (Enterotoxigenic E. coli, Enteroaggregative E. coli, Campylobacter sp., C. jejuni, S. aureus, K. oxytoca, and C. perfringens for the EI group). Data were shown as all strains total. Concerning microbiological outcome by causative strain, bacteria elimination rate (BER) and its 95% confidence interval (CI) were calculated. The BER was the proportion of causative strains assessed as either "Excellent" or "Good" except for those assessed as "unknown/indeterminate".
Time to Maximum Plasma Concentration (Tmax) of OPS-2071 on Day 4
时间窗: 1h, 2h, and 4h after morning administration
We measured OPS-2071 concentration in plasma and evaluated tmax of OPS-2071 in plasma.
次要结局
- Number of Subjects With Formed Stool, Liquid or Unformed Stool, and Bloody Stool After Multiple Doses of OPS-2071(CDI group: screening, Day 4, Day 11 (end of treatment) and Day 38, EI group: screening, Day 4 and Day 8 (end of treatment))
- Clinical Response Rate (CRR) in the CDI and EI Groups(CDI group: Day 4 and Day 11 (end of treatment), EI group: Day 4 and Day 8 (end of treatment))
- Number of Subjects With Abdominal Pain, Nausea, and Vomiting After Multiple Doses of OPS-2071(CDI group: screening, Day 4, Day 11 (end of treatment) and Day 38, EI group: screening, Day 4 and Day 8 (end of treatment))
- The Recurrence Rate of CDI After Multiple Doses of OPS-2071 (for CDI Group Only)(Day 38)
- The Time to Resolution of Diarrhea After Multiple Doses of OPS-2071(CDI group: Day 4, Day 11 (end of treatment) and Day 38, EI group: Day 4 and Day 8 (end of treatment))
- Stool Frequency Per Day After Multiple Doses of OPS-2071(CDI group: screening, Day 4, Day 11 (end of treatment) and Day 38, EI group: screening, Day 4 and Day 8 (end of treatment))