NCT01398098已完成2 期
Gastric Emptying Time Assessment During Bowel Preparation With COLOKIT®
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of patients with a residual antral volume lower than 20 mL
研究概览
简要总结
Ultra-sound study to assess changes in intragastric volume after bowel preparation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject who signed an informed consent to participate in the trial.
- •Subject affiliated with Social Security
- •Men and women aged 18 to 75 years.
- •Subject with an indication of scheduled outpatient colonoscopy.
- •colonoscopy performed within six hours after the second sequence COLOKIT®.
- •Subject able to swallow tablets.
排除标准
- •Women pregnant or likely to be (without contraception) or nursing.
- •Subject having any of the following diseases or conditions:
- •allergy or hypersensitivity to the product tested or any of its excipients,
- •nausea, vomiting or abdominal pain,
- •clinically significant renal failure,
- •primary hyperparathyroidism associated with hypercalcemia,
- •congestive heart failure,
- •a known or suspected bowel obstruction,
- •megacolon (congenital or acquired)
- •intestinal perforation,
- •an inflammatory disease or suspected inflammatory bowel disease,
- •swallowing disorders,
- •known digestive motor disorders (gastroparesis, scleroderma, mega-esophagus),
- •diabetes mellitus (insulin or non insulin-dependent)
- •a history of gastric surgery (partial or total)
- •a contraindication to the anesthesia required for the completion of the colonoscopy,
- •Any clinical condition which, in the opinion of the investigator, would not allow the subject to perform the test in good conditions.
研究组 & 干预措施
COLOKIT®
Experimental
干预措施: Sodium phosphate (Drug)
结局指标
主要结局
Percentage of patients with a residual antral volume lower than 20 mL
时间窗: after 2nd treatment regimen intake
次要结局
- Adverse events(After drug intake)
- Acceptability of COLOKIT®.(After drug intake)
- Colonoscopy results(After colonoscopy.)
研究者
研究点 (1)
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