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临床试验/NCT01649674
NCT01649674进行中(未招募)4 期

PRECOL2011-1: Sodium Picophosphate and Magnesium Citrate Versus Polyethylene Glycol as Evacuating Treatment Prior to Colonoscopy: Phase IV Randomized Trial.

National Cancer Institute, Naples7 个研究点 分布在 1 个国家目标入组 525 人开始时间: 2011年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
进行中(未招募)
发起方
入组人数
525
试验地点
7
主要终点
Boston Bowel Preparation Scale value

研究概览

简要总结

The purpose of this study is to to compare two bowel preparation regimens of patients who will undergo colonoscopy, in terms of quality of bowel preparation and in terms of patient satisfaction.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects who are candidate to undergo colonoscopy: Diagnosis Screening Follow-up after previous polypectomy
  • Informed consent
  • Age > 18 years

排除标准

  • Previous colonic resection
  • Severe inflammatory bowel disease (IBD)

研究组 & 干预措施

PEG

Active Comparator

polyethylene glycol solution 2 liters

干预措施: polyethylene glycole (PEG) solution (Drug)

NapP

Active Comparator

Sodium picosulphate and magnesium citrate solution 300 ml

干预措施: sodium picosulphate and magnesium citrate solution (Drug)

结局指标

主要结局

Boston Bowel Preparation Scale value

时间窗: at time of colonscopy

evaluated by two endoscopists who are blinded to treatment assigned at randomization

patient reported acceptability score

时间窗: just prior to colonscopy

using visual analog scale

次要结局

  • percent of bowel cleansing regimen dose assumed as reported by patient(just prior to colonoscopy)

研究者

发起方
National Cancer Institute, Naples
申办方类型
Other
责任方
Sponsor

研究点 (7)

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