KCT0008442尚未招募未知
Comparison of efficacy and safety of 1-L polyethylene glycol plus ascorbic acid for bowel preparation: a randomized multicenter clinical trial
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 261
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 74(Year)（—）
- 性别
- All
入选标准
- •A patient who is deemed to require an endoscopy due to complaints of digestive symptoms and meets all of the following selection criteria:
- •(1) Adult males and females between the ages of 19 and 74
- •(2) Individuals scheduled to undergo upper/lower gastrointestinal endoscopy
- •(3) Body Mass Index (BMI) = 30
- •(4) Voluntarily consents to participate in this clinical trial and signs the consent form.
排除标准
- •Individuals who meet any of the following criteria:
- •(1) History of the following surgeries, medical conditions, or comorbidities:
- •- Dehydration
- •-Colorectal resection
- •- Gastrointestinal obstruction (intestinal obstruction, gastrointestinal obstruction, etc.), perforation, or gastric outlet obstruction (gastroparesis, etc.)
- •- Inflammatory bowel disease (ulcerative colitis, Crohn's disease, etc.) or toxic megacolon
- •- Regular or ongoing use of laxatives or stool softeners, or severe constipation requiring physical intervention (e.g. more than 3 bowel movements per week)
- •- Severe cardiac disease (NYHA class 3,4 heart failure, acute coronary artery disease within 24 weeks prior to screening, clinically significant arrhythmias, hypertrophic obstructive cardiomyopathy, valvular heart disease, aortic disease, and peripheral vascular disease)
- •- History of cardiac arrest
- •- Blood coagulation disorders
- •- Severe chronic kidney disease (eGFR or CrCl < 30, gross hematuria)
- •- Active cancer patients at screening
- •- Major psychiatric disorders (depression, bipolar disorder, etc.) or history of drug/alcohol abuse
- •- Patients with loss of consciousness
- •(2) individuals with the following abnormal test results:
- •- Creatinine >= 2 x upper limit of normal
- •- AST or ALT >= 3 x upper limit of normal
- •(3) Pregnant or breastfeeding women, or individuals planning to become pregnant during the screening period
- •(4) Glucose-6-phosphate dehydrogenase deficiency patients
- •(5) Patients with confirmed or suspected phenylketonuria
- •(6) Patients with hypersensitivity or allergy to any component of the investigational product during the clinical trial
- •(7) Individuals requiring concomitant use of prohibited drugs during the clinical trial period
- •(8) Individuals who have received investigational drugs or medical devices in other clinical trials
- •(9) Other individuals who are deemed unsuitable for participation in the study by the investigator.
研究者
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