Test of a New Gel-based Colon Cleansing Agent Compared to Moviprep. A Randomized Single-blinded Cross-over Study
试验速览
- 阶段
- 1 期
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Boston Bowel preparation scale (BBPscale)
研究概览
简要总结
Crossover study comparing Moviprep (for bowel cleansing) with a new gel-based colon cleansing agent before colonoscopy
详细描述
Crossover study comparing Moviprep (for bowel cleansing) with a new gel-based colon cleansing agent before colonoscopy.
Study performed in health subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Allergy to content of products
研究组 & 干预措施
Geloprep
Novel and patented Polyethylene glycol 3350 mixture
干预措施: A 06 ad (Drug)
Moviprep
Standard of care Polyethylene glycol 3350 mixture
干预措施: A 06 ad (Drug)
结局指标
主要结局
Boston Bowel preparation scale (BBPscale)
时间窗: Performed during the endoscopy procedure
Visual assessment of the degree of bowel cleansing performed by the endoscopist (blinded). Right colon, colon transversum, and left colon are each judged on a scale from 0-3 with higher scores indicating better cleansing. Range of score between 0-9.
Adverse events related to intervention
时间窗: Assessed 4 hours after last intake of cleansing product
Any adverse event related to the intervention observed by investigators or as reported by the participant
次要结局
- Blood pressure(Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination)
- Saturation(Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination)
- Heart rate(Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination)
- Respiration frequency(Measured immediately before the colonoscopy starts, and every 5 minutes during colonoscopy and immediately after the end of the examination)