NCT02179658已完成3 期
OPT-80 Phase III Study -A Multi-center, Double Blinded, Randomized, Parallel Group Study To Compare The Safety, Pharmacokinetics And Efficacy of OPT-80 With Vancomycin In Subjects With Clostridium Difficile-Associated Diarrhea (CDAD)
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
- 210
- 主要终点
- Global cure rate
研究概览
简要总结
The primary objective of this study is to investigate the safety and efficacy of OPT-80 versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).
详细描述
This is a multicenter, double-blind, randomized, parallel group study. The subjects who meet all of the inclusion criteria and none of the exclusion criteria will be randomized, and will orally receive either OPT-80 twice daily or vancomycin powder four times daily for 10 days. A follow-up investigation will be performed 28 (±3) days after the completion of study drug administration.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients who have symptoms of CDAD as defined by;
- •(1)Diarrhea: with ≥4 unformed bowel movements (or ≥200 mL unformed stool for subjects having rectal collection devices) and
- •(2)Presence of either toxin A and/or B of C. difficile in the stool
- •Subjects who have not received antibacterials (vancomycin, metronidazole, et.al.) aiming at CDAD treatment before the study
排除标准
- •Life-threatening or fulminant CDAD
- •Ileus paralytic or toxic megacolon
- •Likelihood of death before the completion of study from any cause
- •Concurrent use of oral vancomycin, metronidazole, et.al. aiming at the treatment of CDAD
- •The anticipated need to continue other antibacterials for a period exceeding seven days from providing the informed consent
- •Subjects who in the opinion of the investigator require other drugs to control diarrhea
- •Need of change in dosage regimen of opiates during the study period
- •Need of change in dosage regimen of probiotic products during the study period
- •History/complications of ulcerative colitis or Crohn's disease
- •Multiple occurrences of CDAD within the past three months
- •Hypersensitivity to vancomycin
- •Previous exposure to OPT-80 (fidaxomicin)
- •Female patients who are pregnant, breastfeeding or possibly pregnant, or wishing to become pregnant during the course of study
- •Participation in other clinical research studies or Post Marketing Clinical Trials utilizing an investigational agent within one month prior to providing the informed consent or within five half-lives of the investigational agent, whichever is longer
研究组 & 干预措施
Vancomycin group
Active Comparator
Oral
干预措施: vancomycin (Drug)
OPT-80 group
Experimental
Oral
干预措施: OPT-80 (Drug)
结局指标
主要结局
Global cure rate
时间窗: Up to 38 days
Global cure rate is the rate of the subjects satisfying both of the following: being cured at the completion of study drug administration; without recurrence during the follow-up period
次要结局
- Fecal concentration of OPT-80(fidaxomicin)(Day 10-11)
- Microbiological efficacy(Up to 38 days)
- Plasma concentration of OP-1118(Before administration, Day 1 and Day 10-11)
- Cure rate(Day 10 -11 of the study period)
- Time to resolution of diarrhea(up to 38 days)
- Fecal concentration of OP-1118(Day 10-11)
- Safety assessed by the incidence of adverse events, vital signs, ECGs and laboratory tests(Up to 38 days)
- Recurrence rate of CDAD(during the 4-week follow-up period, up to Day 38)
- Plasma concentration of OPT-80(fidaxomicin)(Before administration, Day 1 and Day 10-11)
研究者
相似试验
Unknown
3 期
R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Grade 3BDiffuse Large B-cell LymphomaFollicular Lymphoma Grade 3BNCT01852435Ruijin Hospital648
Unknown
3 期
Intranasal PH80 Spray for Acute Management of the Symptoms of Premenstrual Dysphoric DisorderPremenstrual Dysphoric DisorderNCT01217775Pherin Pharmaceuticals, Inc.1,400
招募中
3 期
A Study to Evaluate Efficacy and Safety of AVTX-803 in Patients With Leukocyte Adhesion Deficiency Type IILeukocyte Adhesion DeficiencyNCT05462587AUG Therapeutics4
已完成
2 期
Efficacy and Safety of TV-1380 as Treatment for Facilitation of Abstinence in Cocaine-Dependent SubjectsCocaine AddictionNCT01887366Teva Branded Pharmaceutical Products R&D, Inc.208
已完成
1 期
Phase 1-2 Evaluation of OT-730 Eye Drops in Reducing the Intraocular Pressure in Patients With Ocular Hypertension or Open-Angle GlaucomaGlaucoma, Open-AngleOcular HypertensionNCT00753168Othera Pharmaceuticals48