NCT05670470已完成3 期
A Prospective, Randomized, Investigator-blinded, Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Number of Patients With Successful Bowel Cleansing (Overall Colon)
研究概览
简要总结
This is a prospective randomized study compared with active control arm.
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
- Single (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
- •Male and female outpatients and inpatients aged: ≥19
- •A prospective colonoscopy person
- •Written informed consent to participate in the trial
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, Hartmann's procedure and defunctioning ileostomy or other similar surgeries involving structure and function of the small or large colon.
- •Pregnant women or pregnant women or pregnant women
- •Patients who have not been confirmed to have COVID-19 for a month
- •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
- •Patients with severe chronic renal impairment (glomerular filtration rate less than 30ml/min/1.73m2)
- •People who have hypersensitivity or allergies to clinical trial drug components
研究组 & 干预措施
CTP0303
Experimental
干预措施: CTP0303 (Drug)
Orafang Tab
Active Comparator
干预措施: Orafang Tab (Drug)
结局指标
主要结局
Number of Patients With Successful Bowel Cleansing (Overall Colon)
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
- Number of Patients With 'Excellent Plus Good' (Highly Effective) Bowel Cleansing (Colon Ascendens)(1 day of scheduled colonoscopy)
- Adenoma/Polyp Detection Rate (Overall Colon)(1 day of scheduled colonoscopy)
研究者
研究点 (1)
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