Comparison for Efficacy and Safety of Bowel Preparation Between Oral Sulfate Table and 2L-polyethylene Glycol/Ascorbate in Elderly: Multicenter, Prospective, Investigator Single-blinded, Randomized Study
试验速览
- 阶段
- 4 期
- 入组人数
- 256
- 主要终点
- Successful cleaning rate1
研究概览
简要总结
This study compares the effectiveness and stability of intestinal tablet (OST), an oral sulfate table (OST), developed in the form of pills, with 2L-PEG/Asc for examinees aged 70 or older who are scheduled for colonoscopy.
详细描述
This study is comparison for efficacy and safety of bowel preparation between oral sulfate table and 2L-polyethylene glycol/ascorbate in elderly: multicenter, prospective, investigator single-blinded, randomized study. A total of 256 subjects will participate to this study and be assigned to the test group or the control group. The subject will administer the first dose of assigned investigational product in the evening prior to the scheduled colonoscopy. Subject will take the second dose early in the morning of the colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age over 70
- •Patients who is scheduled a colonoscopy
- •Patients who is informed and give a consent in voluntary
排除标准
- •History of colectomy
- •Patients over American Society of Anesthesiology class III
- •Patients who has difficulty swallowing
- •In the case of abnormal findings requiring treatment in the basic blood test
- •Patients with uncontrollable chronic diseases
- •Patients suspected of having Paralytic ileus or intestinal obstruction.
- •Patients who complains of alarm sign (severe abdominal pain, weight loss, anemia, gastrointestinal bleeding, etc.)
- •Patients who has a history of drug abuse and addiction
- •Patients who for any reason, are deemed by the Investigator to be inappropriate for this study
研究组 & 干预措施
OST
2 days split dosing regimen
干预措施: OST (Drug)
2L-PEG/Asc
2 days split dosing regimen
干预措施: 2L-PEG/Asc (Drug)
结局指标
主要结局
Successful cleaning rate1
时间窗: Two days (from day of first dosing to day of colonoscopy)
%Patient with Boston Bowel Preparation Scale (BBPS) scored over 2 in all segment
Successful cleaning rate2
时间窗: Two days (from day of first dosing to day of colonoscopy)
%Patient with HCS-graded A or B
次要结局
- Treatment compliance(Two days (from day of first dosing to day of colonoscopy))