Efficacy, Safety and Tolerability of a Split-dose of a New Bowel Cleansing Preparation (BLI800) in Adult Subjects Undergoing Colonoscopy: A Phase III, Multicentre, RANDOMIZED, 2 Parallel- Group, Comparative Versus Fortrans®, Non-inferiority, Investigator/Assessor-blinded Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 297
- 试验地点
- 10
- 主要终点
- The proportion of subjects with successful overall preparation based on a centrally assessed global BBPS score (for all segments) ≥ 6 (centralised assessment).
研究概览
简要总结
The purpose is to demonstrate that BLI800 is non-inferior, on overall colon cleansing, to Fortrans® (a reference colonic lavage in China) administered in adult subjects scheduled to undergo a colonoscopy for a routinely accepted diagnostic indication.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of written informed consent signed prior to any study related procedures.
- •Male or female, at least 18 years old undergoing colonoscopy for a routine diagnostic indication, such as: a. Routine cancer screening b. Polyp or neoplasm history c. Diagnostic procedure for occult bleeding or anaemia d. Diarrhoea or constipation of unknown aetiology e. Inflammatory Bowel Disease (IBD) not in severe active phase
- •In good clinical condition (physical exam and medical history)
- •Adequate fluid balance, and adequate electrolyte balance (measured during screening K, Na, Cl, anion gap/bicarbonate/carbon dioxide content within normal/within ±10% of normal range)
排除标准
- •Abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardise the subject's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study.
- •Advanced carcinoma or any other colon disease leading to excessive mucosal fragility.
- •Known or suspected gastrointestinal (GI) obstruction, gastric retention, gastroparesis, or disorder of gastric emptying.
- •Known or suspected ileus.
研究组 & 干预措施
BLI800
BLI800 given orally as a split-dose: 1st dose the evening before colonoscopy (e.g. at 6:00 p.m.- 8:00 p.m.) and 2nd dose on the morning of colonoscopy, 10 to 12 hours after the evening dose (e.g. at 5:00 a.m.-7:00 a.m.)
干预措施: BLI800 (Drug)
Fortrans®
Fortrans® given orally as a split dose: 1st dose the evening before colonoscopy (e.g. at 6:00 p.m - 8:00 p.m.) and 2nd dose on the morning of colonoscopy, 10 to 12 hours after the evening dose (e.g. at 5:00 a.m.-7:00 a.m.)
干预措施: Fortrans® (Drug)
结局指标
主要结局
The proportion of subjects with successful overall preparation based on a centrally assessed global BBPS score (for all segments) ≥ 6 (centralised assessment).
时间窗: Through study completion, an average of 1 year
Efficacy of BLI800 versus Fortrans® will be evaluated with the BBPS global score which ranges from 0 to 9. It will be blindly scored and evaluated by a centralised assessment (blinded assessors will assess the electronic record of colonoscopy and rate it).
次要结局
- Rate of adenomas detected, evaluated by the investigator(Through study completion, an average of 1 year)
- Proportion of subjects for whom total colonoscopy could be completed, evaluated by the investigator(Through study completion, an average of 1 year)
- Investigator satisfaction evaluated by 5-point Likert scale score(Day 2)
- BBPS score by segment (0 to 3), scored in blind and evaluated by centralised assessment(Through study completion, an average of 1 year)
- Rate of other lesions including cancer, evaluated by the investigator(Through study completion, an average of 1 year)
- Duration of the colonoscopy(Day 2)
- Patient compliance with BLI800 versus Fortrans®(Through study completion, an average of 1 year)
- Assessment of cleanliness by investigators using the Boston Bowel Preparation Scale (BBPS)(Day 2)
- Rate of polyp detection, evaluated by the investigator(Through study completion, an average of 1 year)
- Patient Satisfaction with BLI800 versus Fortrans®(Day 2)
- Patient tolerability with BLI800 versus Fortrans®(Day 2)