NCT01946971已完成1 期
Lansoprazole in Preterm Infants With Gastroesophageal Reflux
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Acid reflux time (%)
研究概览
简要总结
This study is crossover study to evaluate safety and efficacy of lansoprazole in preterm infants with gastroesophageal reflux.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infant
- •symptoms suspecting gastroesophageal reflux
排除标准
- •unstable general conditions due infection or acute illness
- •congenital anomaly in upper gastrointestinal tract including esophagus
- •drug history of H2, proton pump inhibitor, blocker during last 1 week
- •medication of warfarin, carbamazepine, phenytoin, rifampin
- •inappropriate clinical conditions judged by researchers
研究组 & 干预措施
LP
Experimental
Lansoprazole 1mg/kg orally once a day for 7 days, then placebo orally once a day for 7 days
干预措施: Placebo (Drug)
PL
Experimental
Placebo once a day orally for 7 days, then lansoprazole 1mg/kg once a day orally for 7 days
干预措施: Lansoprazole (Drug)
PL
Experimental
Placebo once a day orally for 7 days, then lansoprazole 1mg/kg once a day orally for 7 days
干预措施: Placebo (Drug)
LP
Experimental
Lansoprazole 1mg/kg orally once a day for 7 days, then placebo orally once a day for 7 days
干预措施: Lansoprazole (Drug)
结局指标
主要结局
Acid reflux time (%)
时间窗: day 0, day 7, day 14
measured by 24hr pH impedance monitor
次要结局
- Acid reflux frequency(day 0, day 7, day 14)
- Composite score(day 0, day 7, day 14)
- Acid reflux fraction(day 0, day 7, day 14)
- acid bolus reflux time/%,(day 0, day 7, day 14)
- nonacid bolus reflux time/%(day 0, day 7, day 14)
- bolus reflux time/%(day 0, day 7, day 14)
- I-GERQ GERD score(day 0, day 7, day 14)
研究者
Han-Suk Kim
Professor
Seoul National University Hospital
研究点 (1)
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