NCT02819323已完成3 期
A Safety and Efficacy Study of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
Braintree Laboratories27 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2016年6月最近更新:
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
- 91
- 试验地点
- 27
- 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 compare the safety, tolerance and efficacy of BLI800 to a PEG based preparation prior to colonoscopy in adolescent 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
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between the ages of 12 to 16 (inclusive)
- •Undergoing colonoscopy for routinely accepted indications, including (but not limited to):
- •Subjected inflammatory bowel disease (IBD) or IBD follow-up
- •Lower gastrointestinal bleeding
- •Suspected colitis (allergic or other)
- •Abdominal pain
- •Chronic diarrhea
- •Cancer surveillance
- •Anemia of unknown etiology
- •Abnormal endosonography or manometry
- •Evaluation of barium enema results
- •If female, and of child-bearing potential, subject must use an acceptable form of birth control or remain abstinent for the duration of the study.
- •Negative pregnancy test at screening, if applicable
- •In the Investigator's judgment, caregiver is mentally competent to provide informed consent for their child to participate in the study.
排除标准
- •Subjects with known or suspected ileus, impaction, severe ulcerative colitis, acute peritonitis, gastrointestinal obstruction, gastric retention (gastroparesis), bowel perforation, toxic colitis or megacolon.
- •Subjects who had previous significant gastrointestinal surgeries.
- •Subjects with increased risk of bowel perforation, including connective tissue disorders, toxic dilation of the bowel or recent bowel surgery.
- •Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, uncorrected dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.
- •Subjects with bleeding disorders and/or impaired platelet function, or neutropenia.
- •Subjects with a prior history of renal, liver or cardiac insufficiency (including congestive heart failure or other significant cardiac abnormality)
- •Subjects with estimated glomerular filtration rate (GFR) below normal range (less than 70 ml/min/1.73m2)
- •Subjects required to take any other oral medication within 3 hours of dosing until completion of both doses.
- •Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
- •Subjects with tendency for nausea and/or vomiting, or that have known swallowing disorders.
- •Subjects for whom intake of substances is likely to affect gastrointestinal motility or urinary flow rate.
- •Subjects undergoing colonoscopy for foreign body removal and/or decompression.
- •Subjects with an abnormal ECG result at Visit
- •Subjects who are pregnant or lactating, or intending to become pregnant during the study.
- •Subjects of childbearing potential who refuse a pregnancy test.
- •Subjects with a history of hypersensitivity 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 and history of major medical/psychiatric conditions that would compromise the safety of the study.
- •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
BLI800 high dose
Experimental
BLI800 bowel preparation (high dose)
干预措施: BLI800 (Drug)
BLI800 low dose
Experimental
BLI800 bowel preparation (low dose)
干预措施: BLI800 (Drug)
PEG-ELS
Active Comparator
PEG based bowel preparation
干预措施: PEG-ELS (Drug)
结局指标
主要结局
Number and Percentage of Subjects With Successful Bowel Cleansing
时间窗: 2 days
Cleansing is rated by a 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 (27)
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