NCT02376465已完成2 期
A Pilot Evaluation of an Experimental BLI4600 Formulation for Bowel Preparation in Adult Patients Undergoing Colonoscopy
Braintree Laboratories1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- % of subjects with successful preparation on a 4 point scale (1 = poor, 2 = fair, 3 = good, 4 = excellent)
研究概览
简要总结
To evaluate the safety, tolerance and efficacy of BLI4600 in multiple dosing regimens as a bowel preparation prior to colonoscopy in adult patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •At least 18 years of age
- •If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, abstinent, or vasectomized spouse).
- •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 (e.g. colostomy, colectomy, gastric bypass, stomach stapling).
- •Subjects with uncontrolled pre-existing electrolyte abnormalities, 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
BLI4600 Regimen 1
Experimental
Oral bowel preparation for colonoscopy
干预措施: BLI4600 bowel preparation (Drug)
BLI4600 Regimen 2
Experimental
Oral bowel preparation for colonoscopy
干预措施: BLI4600 bowel preparation (Drug)
PEG based below preparation
Active Comparator
Oral bowel preparation for colonoscopy
干预措施: PEG based bowel preparation (Drug)
结局指标
主要结局
% of subjects with successful preparation on a 4 point scale (1 = poor, 2 = fair, 3 = good, 4 = excellent)
时间窗: 1 Day
% of subjects with successful preparation by colonoscopist on a 4 point scale (1 = poor, 2 = fair, 3 = good, 4 = excellent)
次要结局
- Ottawa Bowel Preparation Scale Score(1 Day)
研究者
研究点 (1)
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