Pilot Study to Assess Tolerability and Feasibility of Oral Sulfate Solution (SUPREP) in Hospitalized Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 124
- 主要终点
- Non-inferiority design to compare SUPREP to GoLytely (standard of care)
研究概览
简要总结
This study will test the efficacy, tolerability, and feasibility of an oral sulfate solution (SUPREP) for inpatient colonoscopy preparation, compared to the standard of care (GoLytely). The hypothesis is that SUPREP will be well tolerated and non-inferior to standard polyethylene glycol bowel preparation for colonoscopies in an inpatient setting. To test this, at least 124 subjects who are undergoing an inpatient colonoscopy will be randomized to receive either SUPREP or standard of care. The Boston Bowel Preparation Score will be collected as standard of care for both groups. Safety will be monitored from standard of care blood tests and ECG (when indicated). Subjects will be given a survey to assess how tolerable they found the procedure.
A non-inferiority design will be used to compare SUPREP to the standard of care polyethylene glycol preparation. Data analysis will be performed on Boston Bowel Preparation Score and rate of failure of preparation (measured as number of successful subsequent colonoscopies).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be approached with consent for the study only if there is a clinical indication for pursuing an inpatient colonoscopy
排除标准
- •Inability to consent (patient or POA)
研究组 & 干预措施
Oral sulfate solution (SuPREP arm)
Per the package insert: The dose for colon cleansing requires administration of two bottles of SUPREP Bowel Prep Kit. Each bottle is administered as 16 oz of diluted SUPREP solution with an additional 1quart of water taken orally. The total volume of liquid required for colon cleansing (using two bottles) is 3 quarts (approximately 2.8 L) taken orally prior to the colonoscopy outlined below under frequency.
Two 6 oz bottles of oral solution: Each 6 oz bottle contains: sodium sulfate 17.5 g, potassium sulfate 3.13 g, magnesium sulfate 1.6 g.
干预措施: SUPREP Bowel Prep Kit (Drug)
Polyethelene Glycol (GoLytely arm)
Polyethylene Glycol Bowel Prep Kit
干预措施: Golytely Oral Product (Drug)
结局指标
主要结局
Non-inferiority design to compare SUPREP to GoLytely (standard of care)
时间窗: 6 months
Boston Bowel Preparation Score
次要结局
- Failure of performing colonoscopy(6 months)
研究者
Vanessa Shami, MD
Professor of Medicine
University of Virginia