NCT04446312已完成3 期
A Safety and Efficacy Comparison of BLI4900 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
Braintree Laboratories34 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年7月13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
- 500
- 试验地点
- 34
- 主要终点
- Proportion of Subjects With Successful Bowel Preparation
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of BLI4900 bowel preparation to an FDA-approved control 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 inflammatory bowel disease who have a history of any bowel resection (small intestine or colon), suspected active inflammation, or symptoms suggestive of obstruction or known bowel stricture.
- •Subjects who had previous significant gastrointestinal surgeries.
- •Subjects who have regularly used laxatives or colon motility altering drugs in the last month (i.e. more than 2-3 times per week) and/or laxative use within 72 hours prior to administration of the preparation
- •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.
- •Subjects with uncontrolled hypertension.
- •Subjects taking antibiotics within 7 days of colonoscopy.
- •Subjects with severe renal, hepatic or cardiac insufficiency.
- •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 taking tricyclic antidepressants.
- •Subjects using drugs of abuse, including abused prescription medications.
- •Subjects who are withdrawing from alcohol or benzodiazepines.
研究组 & 干预措施
BLI4900
Experimental
Experimental bowel preparation solution for oral ingestion
干预措施: Bowel Prep (Drug)
FDA Approved Control
Active Comparator
FDA approved bowel preparation solution for oral ingestion
干预措施: Bowel Prep (Drug)
结局指标
主要结局
Proportion of Subjects With Successful Bowel Preparation
时间窗: 2 days
Successful bowel preparation is defined as a preparation rated as Excellent or Good by the blinded endoscopist on a 4 point scale (Excellent, Good, Fair, Poor).
次要结局
未报告次要终点
研究者
研究点 (34)
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