A Prospective, Randomized, Single-blinded (Evaluator), 3-treatment Arm, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of CDFR0612 and CDFR0613
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 4
- 主要终点
- Successful cleansing rate
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of CDFR0612 and CDFR0613 compared to PEG+picosulfate (Coolprep Powder) preparation. The effectiveness for bowel cleansing will be assessed with Harefield Cleansing Scale (HCS) by blinded assessor.
详细描述
This study is a prospective, randomized, single-blinded, parallel, 3-treatment, multi-center clinical trial. A total of 297 subjects scheduled for colonoscopy will participate to this study and be assigned to 3 groups - CDFR0612, CDFR0613, or a comparator (Coolprep Powder). A subject will admit to hospital one day before colonoscopy and be administrated with study drug. In early morning at the that day of colonoscopy, he/she will be administrated with study drug again. Any subject will be carefully monitored for safety during hospitalisation (1 night) and additional 4 weeks follow-up period because this study is the first human trial of CDFR0612 and CDFR0613.
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
- 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
- 否
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)
- •Dialysis or renal disorder (creatinine clearance <15ml/min)
- •Suspected pulmonary aspiration or gag reflex disorder
- •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
- •Inability in written/verbal communication
研究组 & 干预措施
Test 1
CDFR0612 Solution 150mL will be mixed with water of 350ml to prepare a bowel cleansing preparation solution 500mL. Take it within 30min. After then, take additional water 500ml within 30min.
These processes will be in evening at one day before colonoscopy and in early morning at the same day of colonoscopy.
干预措施: CDFR0612 (Drug)
Test 2
CDFR0613 Solution 150mL will be mixed with water of 350ml to prepare a bowel cleansing preparation solution 500mL. Take it within 30min. After then, take additional water 500ml within 30min.
These processes will be in evening at one day before colonoscopy and in early morning at the same day of colonoscopy.
干预措施: CDFR0613 (Drug)
Comparator
Coolprep Powder A and B will be mixed with water to prepare a mixture of a bowel cleansing preparation solution 500mL. Repeat it twice. Take these of IL (2 * 500mL) within 1 hour. After then, take additional 500ml water.
These processes will be in evening at one day before colonoscopy and in early morning at the same day of colonoscopy.
干预措施: Coolprep Powder (Drug)
结局指标
主要结局
Successful cleansing rate
时间窗: post-colonoscopy at Day 2
%Patient with HCS-graded A or B
次要结局
- Overall cleansing rate(post-colonoscopy at Day 2)
- Mean segmental cleansing score(post-colonoscopy at Day 2)
- Patient reported outcomes(Post-dosing at Day 1 and Day 2)
- Cecal intubation rate(post-colonoscopy at Day 2)
- Mean cecal intubation time(post-colonoscopy at Day 2)
- Mean colonoscopy withdrawal time(post-colonoscopy at Day 2)
- Treatment Compliance(Post dosing at Day 2)
- Polyp detection rate(post-colonoscopy at Day 2)