NCT03023085已完成1 期
A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects
Braintree Laboratories1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 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 evaluate the safety and efficacy of BLI4700 as a bowel preparation prior to colonoscopy in adult patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（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.
- •Have previously had a colonoscopy performed
- •At least 18 years of age
- •Subjects must be scheduled for a morning colonoscopy (prior to 12:00PM)
- •If female, and of child-bearing potential, is using an acceptable form of birth control.
- •Negative urine 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, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
- •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 with a prior history of renal, liver or cardiac insufficiency
- •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 components.
- •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
Experimental
BLI4700 Bowel Preparation
干预措施: BLI4700 (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 blinded colonoscopist on a 4 point scale (1=poor, 2=fair, 3=good, 4 = excellent)
次要结局
未报告次要终点
研究者
研究点 (1)
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