NCT06317350已完成3 期
A Prospective, Randomized, Parallel, Multi-center, Active Controlled, Single Blind (Assessor), Phase 3 Clinical 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
- 318
- 试验地点
- 2
- 主要终点
- To evaluate the successful % of bowel preparation before colonoscopy (colon cleanliness) using the HCS (Harefield Cleansing Scale)
研究概览
简要总结
This is a prospective, randomized, single-blind, parallel, active-controlled, and multi-center Phase III clinical trial.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women between 19 years and 79 age or older as of the date of consent in writing
- •19 kg/㎡ ≤ BMI < 30 kg/㎡
- •a prospective colonoscopy patient
- •For women of childbearing potential, those who agree to use a medically acceptable contraceptive method* during the clinical trial period
- •*hormonal contraceptive, implantation of intrauterine device or intrauterine system, Infertility procedures/surgery (e.g., bilateral ovarian ligation, vasectomy)
- •A person who voluntarily agrees to participate in this clinical trial and signs a written agreement Abbreviation
- •Women of childbearing potential must have a negative serum or urine pregnancy test before Investigational Product administration
排除标准
- •A person having constipation who is regularly administered laxatives or gastrointestinal motility promoters
- •A person with a history of significant gastrointestinal surgeries, including colonic resection, subtotal colectomy, abdominoperineal resection
- •A person diagnosed with acute coronary disease, arrhythmia, cardiomyopathy, cardiac valvular disease, aortic and peripheral vascular disease
- •Active infection or high fever above 38°C
- •Uncontrolled chronic medical illnesses or suspected symptoms that hinder participation such as major cardiac, renal, and metabolic (ex, Subjects with severe renal disease).
- •Clinically significant abnormal laboratory values of screening.(Creatinine, AST or ALT )
- •Active hepatitis B or hepatitis C with positive HBsAg and HCV Ab tests at screening
- •Positive for Human Immuno-deficiency Virus (HIV) at the time of screening
- •Severe nausea or vomiting
- •Severe abdominal distension or abdominal pain
- •A person prone to aspiration or reflux
- •A person who undergoes colonoscopy for the following therapeutic purpose (1) balloon dilatation of the stenosis area (2) non-toxic giant colon or decompression of the S-phase colitis (sigmoid volvulus) (3) Removal of foreign substances (4) Vascular dysplasia, ulcer, tumor and treatment of bleeding after polypectomy
- •A person who is hypersensitive to the ingredients of a clinical trial drug
- •Pregnant woman or a lactating woman
- •A person who has serious mental disabilities
- •A person who requires the administration of drugs prohibited from concomitant use
- •A person who is administered another investigational drug or has been provided with a clinical trial medical device within 6 months prior to participating in a clinical trial
- •The person whom the investigator determines to be unsuitable for this study
研究组 & 干预措施
GNS-212-ER
Active Comparator
干预措施: GNS-212-ER (Drug)
GNS-212-E1
Experimental
干预措施: GNS-212-E1 (Drug)
GNS-212-E2
Experimental
干预措施: GNS-212-E2 (Drug)
结局指标
主要结局
To evaluate the successful % of bowel preparation before colonoscopy (colon cleanliness) using the HCS (Harefield Cleansing Scale)
时间窗: on the day of scheduled colonoscopy
HCS grading of A and B would be classified as successful while C and D would be classified as not successful
次要结局
- Overall patient satisfaction and compliance(before and on the day of colonoscopy)
- Overall rate of bowel preparation(On the day of colonoscopy)
研究者
研究点 (2)
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