A Randomized, Assessor-Blind, Multicenter, Dose-Ranging Study Comparing the Safety and Efficacy of Prepopik® Versus Polyethylene Glycol Preparation (Local Standard of Care) in Children Aged 9 Years to 16 Years
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 9
- 主要终点
- Percentage of Participants Defined by "Excellent" or "Good" in the Aronchick Scale
研究概览
简要总结
To study the efficacy and safety of Prepopik® in children aged 9 to 16 years for overall colon cleansing in preparation of colonoscopy
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
- 9 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 9 years to 16 years, inclusive, being scheduled to undergo elective colonoscopy
- •Subjects must have had 3 or more spontaneous bowel movements per week for 1 month prior to the colonoscopy
- •Female subjects of childbearing potential must undergo a pregnancy test at screening and again at randomization
排除标准
- •Acute surgical abdominal conditions (e.g., acute obstruction or perforation)
- •Hospitalized for inflammatory bowel disease
- •Any prior colorectal surgery, excluding appendectomy, hemorrhoid surgery, or prior endoscopic surgical procedures
- •Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudo obstruction, hypomotility syndrome, colon resection)
- •Gastrointestinal disorder (active ulcer, outlet obstruction, retention, gastroparesis, ileus)
- •Upper gastrointestinal surgery (gastric resection, gastric banding, gastric bypass)
- •Significant cardiovascular disease as determined by the investigator
- •If subject has a history of renal insufficiency, serum creatinine and potassium must be within normal limits
- •Any clinically significant laboratory value at screening, including pre- existing electrolyte abnormality, based on clinical history
- •Hypersensitivity to active ingredients
研究组 & 干预措施
Oral polyethylene glycol (PEG) based preparation (13-16 years)
Local standard of care
干预措施: Oral polyethylene glycol (PEG) based preparation (13-16 years) (Drug)
Prepopik® ½ Sachet x 2 (9-12 years)
Prepopik® ½ Sachet x 2 (9-12 years)
干预措施: Prepopik® ½ Sachet x 2 (9-12 years) (Drug)
Prepopik® 1 Sachet x 2 (9-12 years)
Prepopik® 1 Sachet x 2 (9-12 years)
干预措施: Prepopik® 1 Sachet x 2 (9-12 years) (Drug)
Oral polyethylene glycol (PEG) based preparation (9-12 years)
Local standard of care
干预措施: Oral polyethylene glycol (PEG) based preparation (9-12 years) (Drug)
Prepopik® 1 Sachet x 2 (13-16 years)
Prepopik® 1 Sachet x 2 (13-16 years)
干预措施: Prepopik® 1 Sachet x 2 (13-16 years) (Drug)
结局指标
主要结局
Percentage of Participants Defined by "Excellent" or "Good" in the Aronchick Scale
时间窗: On the day of colonoscopy
Aronchick scale is a 4-point scale that grades colon cleansing as Excellent (\>90% of mucosa seen, mostly liquid stool, minimal suctioning needed for adequate visualization), Good (\>90% of mucosa seen, mostly liquid stool, significant suctioning needed for adequate visualization), Fair (\>90% of mucosa seen, mixture of liquid and semisolid stool, could be suctioned and/or washed) or Inadequate (\<90% of mucosa seen, mixture of semisolid and solid stool which could not be suctioned or washed). The participant is considered to be a responder if overall colon cleansing is "excellent" or "good" on this 4-point scale.
次要结局
- Number of Participants in Each Category of the "Subject's Tolerability and Satisfaction Questionaire"(1 day of colonoscopy)
- Number of Participants With Adverse Events(Up to 33 days after colonoscopy)
- Number of Participants With Abnormal Findings in Laboratory Tests(From up to 42 days prior to colonoscopy, at the day of colonoscopy, and up to 7 days post colonoscopy)
- Number of Participants With Abnormal Findings in Physical Examination(From up to 42 days prior to colonoscopy, on the day of randomization, and at the day of colonoscopy)
- Number of Participants Who Took the Assigned Dose for Colon Cleansing(Approx. 1 day (From the day before colonoscopy to the day of colonoscopy))