NCT03328507已完成2 期
A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects
Braintree Laboratories4 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2017年11月9日最近更新:
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
- 121
- 试验地点
- 4
- 主要终点
- % of Subjects With Successful Bowel Preparation
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of BLI4900 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
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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 (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 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 with uncontrolled hypertension (systolic blood pressure > 170 mmHg and diastolic blood pressure > 100 mmHg).
- •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 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 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
BLI4900
Experimental
BLI4900 Bowel Preparation
干预措施: BLI4900 (Drug)
PEG Control
Active Comparator
Polyethylene glycol-based bowel preparation
干预措施: PEG Control (Drug)
结局指标
主要结局
% of Subjects With Successful Bowel Preparation
时间窗: Day of colonoscopy
% of subjects with successful bowel preparation rated by blinded 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 (4)
Loading locations...
相似试验
已完成
1 期
A Pilot Evaluation of BLI4700 Bowel Preparation in Adult SubjectsColonoscopyNCT03023085Braintree Laboratories120
已完成
2 期
BLI4700-202: A Pilot Evaluation of BLI4700 Bowel Preparation in Adult SubjectsColonoscopyNCT03103581Braintree Laboratories17
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
2 期
A Pilot Evaluation of an Experimental BLI4600 Formulation for Bowel Preparation in Adult Patients Undergoing ColonoscopyBowel Preparation for ColonoscopyNCT02376465Braintree Laboratories45