NCT03509220已完成3 期
A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK-1701TC
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
- 235
- 试验地点
- 5
- 主要终点
- Successful cleansing rate
研究概览
简要总结
This study evaluates the efficacy, safety and tolerability of PBK-1701TC for bowel cleansing before colonoscopy. Half the participants will receive PBK-1701TC and while the other will receive standard oral preparation.
详细描述
This study is a prospective, randomized, single-blinded, parallel, 2-treatment, multi-center clinical trial. A total of 224 subjects will participate to this study and be assigned to the test group or the control group. The subject will administer the first dose of assigned investigational product in the evening prior to the scheduled colonoscopy. Subject will take the second dose early in the morning of the colonoscopy.
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 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
- •Women of childbearing potential who do not agree with appropriate contraception during this study
- •Patients who had experienced any hypersensitivity study drug or ingredient
- •Uncontrolled hypertension
- •Arrhythmia with clinically significant findings from EKG
- •Congestive heart failure; NYHA functional class III or IV; unstable coronary artery disease; myocardiac infarction history within 6 months
- •Uncontrolled diabetes
- •Active infection except acute upper respiratory infection or local skin infection; Fever (38 °C and higher) within 1 week before study administration
- •HIV infection and/or chronic hepatitis B or C
- •Patients who has a difficulty to participate because of severe nausea or vomiting
- •Suspected or confirmed inflammatory bowel disease, toxic colon or toxic megacolon, or gastrointestinal obstruction or perforation; visible bleeding in colon
- •History of colon surgery and abdominal surgery within 6 month; need an emergency surgery
- •Colonoscopy for the following use: treatment of bleeding from such lesions as vascular malformation, ulceration, neoplasia, and polypectomy site (e.g.,electrocoagulation, heater probe, laser or injection therapy); foreign body removal; decompression of acute nontoxic megacolon or sigmoid volvulus; balloon dilation of stenotic lesions (e.g., anastomotic strictures); palliative treatment of stenosing or bleeding neoplasms (e.g., laser, electrocoagulation, stenting)
- •Fluid or electrolyte (Na, K, Ca, Mg, chloride, bicarbonate) disturbance
- •Severe dehydration risk (e.g., rhabdomyolysis, ascites)
- •History of hypersensitivity of drug or others
- •Alcohol or drug abuse within 6 months
- •Clinically significant underlying disease or medical history at investigator's discretion
研究组 & 干预措施
PBK-1701TC
Experimental
2-Day Split-Dosing Regimen
干预措施: PBK-1701TC (Drug)
Standard oral preparation
Active Comparator
2-Day Split-Dosing Regimen
干预措施: Standard oral preparation (Drug)
结局指标
主要结局
Successful cleansing rate
时间窗: Two days (from day of first dosing to day of colonoscopy)
%Patient with HCS-graded A or B
次要结局
- Mean cecal intubation time(Two days (from day of first dosing to day of colonoscopy))
- Mean colonoscopy withdrawal time(Two days (from day of first dosing to day of colonoscopy))
- Overall cleansing rate(Two days (from day of first dosing to day of colonoscopy))
- Mean segmental cleansing score(Two days (from day of first dosing to day of colonoscopy))
- Treatment compliance(Two days (from day of first dosing to day of colonoscopy))
- Patient satisfaction(Two days (from day of first dosing to day of colonoscopy))
- Polyp detection rate(Two days (from day of first dosing to day of colonoscopy))
研究者
研究点 (5)
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