A Prospective, Randomized, Investigator-blinded, Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Ratio of subjects With successful Bowel Cleansing
研究概览
简要总结
A prospective randomized study compared to the active control. Researchers compare colon cleansing in patients undergoing colonoscopy
详细描述
This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must provide written informed consent.
- •Male and female outpatients and inpatients aged: ≥19
- •Patients BMI shoule be ≤ 30
排除标准
- •Patients with past history of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution), known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
- •Patients with ongoing severe acute Inflammatory Bowel Disease.
- •Patients who have had previous significant gastrointestinal surgeries, including colonic resection, subtotal colectomy, abdominoperineal resection, defunctioning colostomy.
- •Pregnant women or pregnant women or pregnant women
- •Severe heart disease (cardiac failure (NYHA class 3 and 4))
- •Acute coronary artery disease within 24 weeks before screening (an unstable angina pectoris, acute myocardial infarction), clinically significant arrhythmia, hypertrophic obstruction Cardiomyopathy, valvular disease, aortic and peripheral vascular diseases.
- •People who have hypersensitivity or allergies to clinical trial drug components.
研究组 & 干预措施
CTP0302-A
2 days split-dose
干预措施: CTP0302-A (Drug)
CTP0302-B
One day dose
干预措施: CTP0302-B (Drug)
Conventional OST
2 days split-dose
干预措施: Conventional OST (Drug)
结局指标
主要结局
Ratio of subjects With successful Bowel Cleansing
时间窗: 1 day of scheduled colonoscopy
The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e. all mucosa could be visualized) and C and D are classified as unsuccessful.
次要结局
- Each segments ratio of subject with successful Bowel Cleansing(1 day of scheduled colonoscopy)