A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of VP 20621 for Prevention of Recurrence of Clostridium Difficile Infection (CDI) in Adults Previously Treated for CDI
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Shire
- 入组人数
- 173
- 试验地点
- 59
- 主要终点
- Number of Participants With Positive Clostridium Difficile Stool Cultures Demonstrating Non-Toxigenic Clostridium Difficile-Strain M3
研究概览
简要总结
The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621 dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the frequency and duration of stool colonization with the VP 20621 strain of C. difficile; (3) to evaluate the efficacy of VP 20621 for prevention of recurrence of CDI; and (4)to select a dose regimen of VP 20621 to be used in future studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Adult subjects, 18 years of age and over, who understand the risks and benefits of participation and have provided written informed consent for the study.
- •Subjects who are experiencing a first event or first recurrence of clostridium difficile (CDI) within the last 28 days and have been successfully treated with an antibiotic for CDI.
- •Subjects who are medically stable.
- •Subjects who are willing and able to comply with the study procedures and visit schedules outlined.
- •If female be post-menopausal, surgically sterile or agree to follow an acceptable method of birth control.
排除标准
- •Subjects who have had more than 2 episodes of CDI within the last 6 months.
- •Subjects who have been diagnosed with Inflammatory Bowel Disease,active Irritable Bowel Syndrome, celiac disease, active gastroparesis, toxic megacolon.
- •GI surgery within 6 weeks before the day of randomization
- •Have known immunodeficiency disorder, such as HIV Infection
- •Pregnant or breast feeding females.
- •Concurrent acute life-threatening diseases.
- •Inability to tolerate oral liquids.
- •Have an absolute neutrophil count < 1000/mm3 at screening
结局指标
主要结局
Number of Participants With Positive Clostridium Difficile Stool Cultures Demonstrating Non-Toxigenic Clostridium Difficile-Strain M3
时间窗: After study drug administration period (14 days) through Week 6
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to 7 days after the last dose of study drug (up to Week 3)
An adverse event (AE) is any untoward, undesired, unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiological observations occurring in a study participant, regardless of causal relationship. TEAEs were defined as all AEs that start during the study drug treatment period (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during the study drug treatment period (and up to 7 days after the last dose of study drug). SAE was any AE that results in any of the following outcomes: death, a life-threatening event, inpatient hospitalization or prolongation of an existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, other medically important events based upon appropriate medical judgement.
次要结局
- Number of Participants With Clostridium Difficile Infection (CDI) Recurrence(Baseline (Day 1) up to Week 6)
- Number of Participants With Use of Antibacterial Treatment for CDI(Baseline (Day 1) up to Week 6)
- Number of Participants With Clinical Events of Diarrhea or Loose/Watery Stools(Baseline (Day 1) up to Week 6)
- Time to First CDI Recurrence(Baseline (Day 1) up to Week 6)