NCT03404401已完成3 期
BLI4700-301: A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
Braintree Laboratories23 个研究点 分布在 1 个国家目标入组 620 人开始时间: 2018年1月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 620
- 试验地点
- 23
- 主要终点
- Number and Percentage of Subjects With Successful Bowel Cleansing
研究概览
简要总结
The objective of this study is to compare the safety and efficacy of BLI4700 bowel preparation to an FDA-approved bowel preparation as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
- •18 to 85 years of age (inclusive)
- •If female, and of child-bearing potential, is using an acceptable form of birth control
- •Negative serum pregnancy test at screening, if applicable
- •In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study
排除标准
- •Subjects with known or suspected ileus, gastrointestinal obstruction, gastroparesis, gastric retention, bowel perforation, toxic colitis or megacolon.
- •Subjects with ongoing severe, acute inflammatory bowel disease
- •Subjects who had previous significant gastrointestinal surgeries.
- •Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
- •Subjects taking diuretics, anti-hypertensive medications, including angiotensin converting enzyme (ACE) inhibitors and Angiotensin II receptor blockers (ARBs), or chronic NSAIDs, that have not been stable for 30 days. NSAID use for occasional pain is not exclusionary.
- •Subjects with uncontrolled hypertension (systolic blood pressure > 170 mmHg or diastolic blood pressure > 100 mmHg).
- •Subjects taking antibiotics within 7 days of colonoscopy.
- •Subjects with severe renal insufficiency (GFR < 30 mL/min/1.73m2).
- •Subjects with known severe hepatic insufficiency (Child Pugh C)
- •Subjects with cardiac insufficiency (NYHA Functional Classifications 3 or 4).
- •Subjects with an abnormal and clinically significant physical examination or ECG finding at Visit
- •Subjects undergoing insulin therapy for any indication.
- •Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
- •Subjects undergoing colonoscopy for foreign body removal and/or decompression.
- •Subjects who are pregnant or lactating, or intending to become pregnant during the study.
- •Subjects of childbearing potential who refuse a pregnancy test.
- •Subjects allergic to any preparation component.
- •Subjects using drugs of abuse, including abused prescription medications.
- •Subjects who are withdrawing from alcohol or benzodiazepines.
- •Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
- •Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.
研究组 & 干预措施
BLI4700 Bowel Preparation
Experimental
干预措施: BLI4700 (Drug)
FDA Approved Bowel Preparation
Active Comparator
干预措施: Polyethylene glycol bowel preparation (Drug)
结局指标
主要结局
Number and Percentage of Subjects With Successful Bowel Cleansing
时间窗: Day of colonoscopy
% of subjects with successful bowel preparation rated by colonoscopist on a 4 point scale (1=poor to 4=excellent)
次要结局
未报告次要终点
研究者
研究点 (23)
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