NCT01786629已完成4 期
BLI800-480: A Safety and Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Braintree Laboratories10 个研究点 分布在 1 个国家目标入组 338 人开始时间: 2012年12月最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 338
- 试验地点
- 10
- 主要终点
- Percentage of Subjects With a Successful Preparation (Cleaning Rated as "Good" or "Excellent")
研究概览
简要总结
To compare the safety, tolerance and efficacy of SUPREP Bowel Prep Kit to an FDA approved control as 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 —（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.
- •At least 18 years of age
- •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 screening laboratory results, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
- •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.
- •Subjects who withdraw consent before completion of Visit 1 procedures.
研究组 & 干预措施
SUPREP Bowel Prep Kit
Experimental
SUPREP Bowel Prep Kit
干预措施: SUPREP Bowel Prep Kit (Drug)
FDA approved bowel preparation
Active Comparator
FDA approved bowel preparation containing electrolytes
干预措施: FDA approved bowel preparation containing electrolytes (Drug)
结局指标
主要结局
Percentage of Subjects With a Successful Preparation (Cleaning Rated as "Good" or "Excellent")
时间窗: Day of colonoscopy
次要结局
未报告次要终点
研究者
研究点 (10)
Loading locations...
相似试验
已完成
3 期
BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult SubjectsColonoscopyNCT00856843Braintree Laboratories136
已完成
3 期
A Safety and Efficacy Comparison of BLI4700 Bowel Prep Versus an FDA-approved Comparator in Adults Prior to ColonoscopyColonoscopyNCT03404401Braintree Laboratories620
已完成
3 期
Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to ColonoscopyColonoscopyNCT04446312Braintree Laboratories500
已完成
3 期
Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to ColonoscopyColonoscopyNCT04446299Braintree Laboratories519
已完成
3 期
A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to ColonoscopyColonoscopyNCT03261960Braintree Laboratories389