NCT04758156Unknown4 期
Comparison Between a 1L of Polyethylene Glycol+Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy: Prospective, Randomized, Parallel, Multi-center Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Boston Bowel Preparation Scale (BBPS)
研究概览
简要总结
Comparison between a 1L of polyethylene glycol+ascorbic acid as a split dose and oral sulfate solution bowel preparation for colonoscopy
study design: prospective, randomized, parallel, multi-center trial in 3 hospitals in Korea ( Seoul National University hospital, Seoul National University Bundang hospital, Seoul Metropolitan Government-Seoul National University )
patient inclusion criteria
- aged 20-75 adults (out-clinic patients) scheduled for colonoscopy for any indication within the normal process of care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult out clinic patients scheduled for colonoscopy for any indication within the normal process of care
排除标准
- •previous history of significant gastrointestinal surgeries (except for appendectomy)
- •known or clinically suspicious Inflammatory bowel disease patients
- •known or suspected ileus/ GI obstruction
- •previous history of major cancer or currently on treating cancer
- •Major cardiovascular disease, respiratory disease, liver, hematologic diseases with complication
- •severe cognitive impairment / dementia / confusion state
- •past history within the last 12 months or current episode of severe constipation severe constipation
- •Regular use of laxatives or colon motility-altering drugs (i. e. more than 2 - 3 times per week) in the last 28 days prior to screening and/or laxative use within 72 hours prior to administration of the preparation)
- •women who are pregnant or lactating
- •known phenylketonuria, glucose-6-phosphate dehydrogenase deficiency
- •those who were allergic to any preparation components.
- •those who, in the opinion of the investigator, should not be included in the study for any reason
研究组 & 干预措施
CleanViewAL
Experimental
1L polyethylene glycol+ascorbic acid split dose
干预措施: CleanViewAL (Drug)
SUPREP
Placebo Comparator
Oral sulfate solutiom
干预措施: SUPREP (Drug)
结局指标
主要结局
Boston Bowel Preparation Scale (BBPS)
时间窗: at the time of colonoscopy procedure
Bowel cleansing score
次要结局
- questionnaire gathered for Tolerability, compliance, satisfaction(on the 1 day of colonoscopy via questionnaire)
研究者
Hyun Jung Lee
Assistant Professor, MD, PhD
Seoul National University Hospital
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Comparison of Low Volume PEG-Asc and Lower Volume PEG-Asc With BisacodylBowel DiseaseColon AdenomaNCT02980562Korea University Anam Hospital200
已完成
不适用
Comparison between 2L Coolprep® and Combination of 1L Coolprep® and bisacodyl as bowel preparation for colonoscopyKCT0000708Seoul National University Hospital187
已完成
3 期
1.2L polyethylene glycol + ascorbic acid versus 2.0L polyethylene glycol-electrolyte acid for outpatient bowel preparation.Colon diseases (Patients undergoing routine total colonoscopy)JPRN-UMIN000020904Takamatsu Red Cross Hospital300
已完成
4 期
Oral Sulfate Solution (SUPREP) Versus Polyethylene Glycol (PEG) Plus Ascorbic AcidCathartic ColonNCT02761213Bo-In Lee200
已完成
不适用
Comparison of 1L PEG plus ascorbic acid with Linaclotide versus Sennoside for colon cleaning in constipated patients: A single blind, randomized controlled clinical trial.JPRN-UMIN000040416Minamiosaka Hospital526