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临床试验/NCT01929668
NCT01929668已完成不适用

Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Patients With Inactive Ulcerative Colitis; Randomized, Single Blind, Multicenter Study

Kyungpook National University Hospital1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
114
试验地点
1
主要终点
Number of patients who are willing to use the same preparation method for the next colonoscopy.

研究概览

简要总结

The purpose of this study is to compare preference of the patients, efficacy of preparation, and safety between 4 L polyethylene glycol and 2 L of polyethylene glycol with ascorbic acid in patients with inactive ulcerative colitis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age >18 years old
  • ulcerative colitis patients without symptoms for at least 1 year
  • ulcerative colitis patients who undergo colonoscopy for surveillance

排除标准

  • subjects who had abdominal surgery
  • pregnant or breast feeding

研究组 & 干预措施

polyethylene glycol

Active Comparator

4L polyethylene glycol

干预措施: polyethylene glycol (Drug)

polyethylene glycol with ascorbic acid

Experimental

2L polyethylene glycol and ascorbic acid

干预措施: polyethylene glycol (Drug)

polyethylene glycol with ascorbic acid

Experimental

2L polyethylene glycol and ascorbic acid

干预措施: Ascorbic Acid (Drug)

结局指标

主要结局

Number of patients who are willing to use the same preparation method for the next colonoscopy.

时间窗: day 1

次要结局

  • Number of patients who have ulcerative colitis symptom aggravation within 30 days after bowel preparation, measured by simple clinical colitis activity index (SCCAI).(within 30 days after bowel preparation for colonoscopy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eun Soo Kim, MD, PhD

Professor

Kyungpook National University Hospital

研究点 (1)

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