NCT05923918招募中3 期
A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK_M2101
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Successful cleansing rate
研究概览
简要总结
This clinical trial was prospective, randomized, single-blind, 3-treatment arm, parallel treatment group, and active-controlled. , Multi-center, Phase 3 confirmatory clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who is informed and give a consent in voluntary
- •Patients who is scheduled a esophagogastroduodenoscopy and colonoscopy
- •BMI 19≤and<30
排除标准
- •Patients who participate in other interventional study or had participated within 30 days before screening
- •Pregnant or breast-feeding women who do not want to stop breast-feeding
- •Uncontrolled hypertension
- •Uncontrolled diabetes
- •Fluid or electrolyte (Na, K, Ca, Mg, chloride, bicarbonate) disturbance
- •HIV infection and/or chronic hepatitis B or C
- •Patients who has a difficulty to participate because of severe nausea or vomiting
- •History of colon surgery and abdominal surgery within 6 month; need an emergency surgery
研究组 & 干预措施
test 1
Experimental
PBK_M2101, 2-Day Regimen
干预措施: PBK_M2101 2-Day (Drug)
test 2
Experimental
PBK_M2101, 1-Day Regimen
干预措施: PBK_M2101 1-Day (Drug)
active Comparator
Active Comparator
active Comparator, 2-Day Regimen
干预措施: Oral Sulfate Tablet 2-Day (Drug)
结局指标
主要结局
Successful cleansing rate
时间窗: From day of first dosing to day of colonoscopy
%Patient with HCS-graded A or B
次要结局
- Patient satisfaction(From day of first dosing to day of colonoscopy)
- Mean cecal intubation time(From day of first dosing to day of colonoscopy)
- Mean colonoscopy withdrawal time(From day of first dosing to day of colonoscopy)
- Polyp detection rate(From day of first dosing to day of colonoscopy)
- Overall cleansing rate(From day of first dosing to day of colonoscopy)
- Treatment compliance(From day of first dosing to day of colonoscopy)
- Mean segmental cleansing score(From day of first dosing to day of colonoscopy)
研究者
研究点 (1)
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