Randomized, Single Blinded Study of Proposed EZ2go Complete Bowel Cleansing System: Evaluation of Its Safety, Efficacy and Patient Tolerance Compared to LOSO Prep, an Over the Counter Laxative Kit for Colonoscopy Bowel Preparation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Measurement of Efficacy
研究概览
简要总结
This study aims to provide safety and efficacy data comparable to available over-the-counter bowel preparations prior to colonoscopy. While there are many bowel preparations available, most of them remain expensive and require prescription from a health provider. The investigators believe EZ2go Complete will provide a non-inferior colon cleansing in a more accessible way (over-the-counter).
To accomplish this goal, the investigators decided to evaluate the proposed EZ2go combination versus currently available over-the-counter bowel preparations. The investigators believe the EZ2go kit will not be inferior to current FDA approved over-the-counter bowel preparations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients referred for routine colorectal cancer screening or surveillance colonoscopy examinations.
- •Male and Female participants 18 years of age and older.
- •Female participants who are not pregnant or planning to become pregnant within the next 90 days, or are sterile or of non-childbearing potential.
- •Negative urine test at the screening visit.
- •Subject is able to read and understand the informed consent form and signs the informed consent form.
排除标准
- •Contraindication to any of the bowel preparations being used in the study.
- •Unable/unwilling to fill out patient questionnaires following procedure.
- •Pregnant or lactating.
- •Unwilling to perform indicated lab work.
- •Lab results that would indicate stage 4-5 chronic kidney disease (GFR <30MI/min1.73 m2).
- •Personal history of colorectal cancer.
- •Personal history of colorectal or small bowel surgery.
- •Participants have any condition that, in the investigators opinion, could interfere with the participation and completion of this study.
研究组 & 干预措施
EZ2go Complete
EZ2go complete: Peg 3350, Magnesium Citrate and Simethicone
干预措施: Ez2go Complete (Other)
LoSo Prep ™
LoSo Prep ™: Magnesium citrate and Bisacodyl
干预措施: LoSo Prep (Other)
结局指标
主要结局
Measurement of Efficacy
时间窗: 24 hours
The primary end point is efficacy of colonoscopy preparation measured by the Ottawa scale.
次要结局
- Evaluate the safety(2 weeks)