A Multi-center, Randomized, Single-blind Clinical Study of the Efficacy and Safety of PICOPREP and Polyethylene Glycol-electrolyte 4000 Powder for Oral Solution (PEG-ELS) for the Bowel Preparation Prior Colonoscopy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 7
- 主要终点
- The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation
研究概览
简要总结
Eligible subjects undergoing a colonoscopy will randomly receive either PICOPREP or polyethylene glycol 4000 electrolyte lavage solution before the procedure to evaluate its effectiveness, tolerability and safety.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have signed the informed consent form and have been verbally explained the details of the trial and treatment procedures
- •Chinese citizen
- •Males or females aged between 18 and 70 years inclusive
- •Patients scheduled for colonoscopy
- •Patients who are able to observe instructions given during the study, and are able to complete the entire study procedure
排除标准
- •Those pregnant, breastfeeding, or with the intention of becoming pregnant, or fertile women who are not on effective birth control
- •Taking concomitant lithium
- •Allergy to any ingredient in the study medication
- •History of gastrointestinal diseases (active ulcers, gastric outlet obstruction, gastric retention, intestinal obstruction)
- •Colon diseases (toxic megacolon, toxic colitis, idiopathic intestinal pseudo-obstruction, gastric retention, intestinal obstruction, lazy bowel syndrome) at screening
- •Active (acute/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
- •Acute abdominal symptoms (acute intestinal obstruction, intestinal perforation, diverticulitis or appendicitis)
- •History of surgery in upper gastrointestinal tract (gastrectomy, gastric banding, gastric bypass surgery)
- •History of colorectal surgery (excluding appendectomy, hemorrhoidectomy and endoscopic surgery)
- •Uncontrolled angina and/or myocardial infarction, congestive heart failure, or uncontrolled hypertension within 3 months prior randomisation
- •Severe liver damage
- •Kidney function impairment
- •Diabetics currently on insulin treatment
- •Having participated in any other clinical trial during the 3 month prior recruitment
- •Patients who are unable to act in a legal capacity, unable to meet or perform study requirements
研究组 & 干预措施
PICOPREP
"Split Dose" method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy.
干预措施: PICOPREP (Drug)
PEG-ELS
PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
干预措施: PEG-ELS (Drug)
结局指标
主要结局
The Ottawa Scale Score of Patients Who Had Successfully Completed the Colonoscopy Examination After Having Completed the Study Bowel Preparation
时间窗: day 2
The total Ottawa Bowel Preparation Scale (OBPS) score, rated by the treatment-blinded Investigator at colonoscopy, was designed to evaluate cleanliness of the colon by grading the endoscopic visibility of the mucosa according to a scale from 0 ('excellent' visibility) to 4 ('inadequate' visibility); The component scores for each of the colon segment are added together, along with an overall 'fluid' score (from small amount = 0, to large amount = 2). Thus, the total OBPS has a range from 0 (a perfect preparation) to 14 (a completely unprepared bowel)
次要结局
- Patient Response to Acceptability and Tolerability Questionnaire(Day 2)
- Ottawa Scale Score by Colon Segment(Day 2)
- Percentage of Successful Completion of Colonoscopy(Day 2)
- Proportion of Successful Colonoscopies in the Clinical Setting (Predicted by Ottawa Scale Score)(Day 2)
- Proportion of Subjects Requiring a Repeat Colonoscopy Due to Poor Bowel Preparation(Day 2)