Efficacy, Safety and Tolerability of a Bowel Cleansing Preparation (BLI800) in Pediatric Subjects Undergoing Colonoscopy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 5
- 主要终点
- % of Subjects With Successful Preparation Rated by Colonoscopist on a 4 Point Scale (1=Poor to 4 = Excellent)
研究概览
简要总结
The purpose o this study is to evaluate the safety, tolerance and efficacy of BLI800 as a bowel preparation prior to colonoscopy in pediatric 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
- None
入排标准
- 年龄范围
- 12 Years 至 17 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 17
- •Weight more than 40kg
- •Undergoing colonoscopy for routinely accepted indications
- •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
- •Subjects with bleeding disorders and/or impaired platelet function, or neutropenia.
- •Subjects with a prior history of renal, liver or cardiac insufficiency
- •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.
研究组 & 干预措施
BLI800 - Dose 1
BLI800 oral solution
干预措施: BLI800 - Dose 1 (Drug)
BLI800 - Dose 2
BLI800 oral solution
干预措施: BLI800 - Dose 2 (Drug)
结局指标
主要结局
% of Subjects With Successful Preparation Rated by Colonoscopist on a 4 Point Scale (1=Poor to 4 = Excellent)
时间窗: 2 days
Successful Preparation, defined as a colonoscopy rated as Excellent or Good by the blinded endoscopist. Poor: Large amounts of fecal residue, additional bowel preparation required; Fair: Enough feces even after washing and suctioning to prevent clear visualization of the entire colonic mucosa; Good: Feces and fluid requiring washing and suctioning, but still achieves clear visualization of the entire colonic mucosa; Excellent: No more than small bits of feces/fluid which can be suctioned easily; achieves clear visualization of the entire colonic mucosa
次要结局
未报告次要终点