A Randomized, Controlled, Single-Blind Study Comparing the Efficacy, Tolerability and Safety of PEG-3350 (Miralax) and Gatorade With PEG-ELS (Golytely) for Bowel Preparation Prior to Colonoscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Quality of bowel prepreparation/cleanliness scored using the Boston Bowel Preparation Scale
研究概览
简要总结
The purpose of this study to to see how well Miralax (PEG-3350) and Gatorade cleans the colon before a colonoscopy and how easy it is to take compared to Golytely (PEG-ELS) bowel preparation solution. Another purpose is to see if taking half of the bowel preparation solution on the evening before the colonoscopy and half on the morning of the colonoscopy will result in a cleaner colon than taking all of the bowel preparation solution on the evening before.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years in age
- •Undergoing full colonoscopy for colorectal cancer screening or colon polyp/cancer surveillance or other diagnostic purpose
排除标准
- •Allergic to polyethylene glycol
- •Pregnant or lactating
- •Baseline abnormalities of relevant serum electrolytes including Sodium, Potassium, Calcium, Magnesium and phosphorus
- •Congestive Heart Failure NY Heart Assn, Grades III and IV
- •Liver Cirrhosis Childs Pugh Class B or C
- •Serum Creatinine greater than 1.5
- •Previous alimentary tract surgery
- •Ongoing symptoms of abdominal pain, bloating, nausea or constipation
- •Ileus, suspected bowel obstruction, toxic colitis or megacolon, severe ulcerative colitis
研究组 & 干预措施
Group 1
4L of PEG-ELS (Golytely) consumed on the evening before colonoscopy
干预措施: PEG-ELS (Golytely) (Drug)
Group 2
2L of PEG-ELS (Golytely) consumed on the evening before and 2L consumed on the morning of colonoscopy
干预措施: PEG-ELS (Golytely) (Drug)
Group 3
238g of PEG-3350 mixed with 2L of Gatorade
干预措施: Miralax mixed with Gatorade (Drug)
Group 4
1L of PEG-3350 + Gatorade
干预措施: Miralax (Drug)
结局指标
主要结局
Quality of bowel prepreparation/cleanliness scored using the Boston Bowel Preparation Scale
时间窗: two years
次要结局
未报告次要终点