NCT00427635已完成3 期
A Randomized, Double-blind, Placebo Controlled, Study to Evaluate the Efficacy and Safety of Esomeprazole Once Daily for the Treatment of Gastroesophageal Reflux Disease (GERD) in Neonatal Patients, Including Premature and up to 1 Month Corrected Age
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring
研究概览
简要总结
The purpose of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal 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
- Double
入排标准
- 年龄范围
- — 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full-term or gestational age >/= 28 to 44 weeks
- •In-patient in Neonatal Intensive Care Unit, special care nursery, or equivalent
- •Patient must be on a stable mode of feeding or with minimal variations for at least 2 days prior to randomization
排除标准
- •Patients with a need for resectional or reconstructive surgery of the gastrointestinal tract
- •Patients with any condition that may require surgery during the course of the study
- •Patients with acute respiratory distress within 72 hours prior to enrollment
结局指标
主要结局
Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring
时间窗: Baseline and end of treatment (10-14 days)
The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.
次要结局
- Change From Baseline in Number of Acidic Reflux Episodes(Baseline and end of treatment (10-14 days))
- Change From Baseline in Number of Weakly Acidic Reflux Episodes(Baseline and end of treatment (10-14 days))
- Change From Baseline in Number of Non Acidic Reflux Episodes(Baseline and end of treatment (10-14 days))
- Change From Baseline in Number of Liquid Acidic Reflux Episodes(Baseline and end of treatment (10-14 days))
- Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes(Baseline and end of treatment (10-14 days))
- Change From Baseline in Number of Reflux Episodes (Acid or Non-acid)(Baseline and end of treatment (10-14 days))
- Change From Baseline in Mean Bolus Clearance Time(Baseline and end of treatment (10-14 days))
- Change From Baseline in Percentage Time With pH<4.0(Baseline and end of treatment (10-14 days))
- Change From Baseline in Percentage Time With pH Within 4.0-6.9(Baseline and end of treatment (10-14 days))
- Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux(Baseline and end of treatment (10-14 days))
- Change From Baseline in Mean Acid Clearance Time(Baseline and end of treatment (10-14 days))
研究者
研究点 (3)
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