Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients
2010年12月2日 更新者：AstraZeneca
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
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.
研究概览
研究类型
介入性
注册 (实际的)
32
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
不超过 1个月 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring
大体时间：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.
|
Baseline and end of treatment (10-14 days)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux
大体时间：Baseline and end of treatment (10-14 days)
|
Event considered associated with reflux if start time of GERD sign/symptom is within 2 minutes of start time of acid reflux.
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.
|
Baseline and end of treatment (10-14 days)
|
|
Change From Baseline in Number of Reflux Episodes (Acid or Non-acid)
大体时间：Baseline and end of treatment (10-14 days)
|
Number of reflux episodes based on 24-hour impedance monitoring data
|
Baseline and end of treatment (10-14 days)
|
|
Change From Baseline in Number of Acidic Reflux Episodes
大体时间：Baseline and end of treatment (10-14 days)
|
Number of reflux episodes (pH<4.0)
based on 24-hour impedance monitoring data
|
Baseline and end of treatment (10-14 days)
|
|
Change From Baseline in Number of Weakly Acidic Reflux Episodes
大体时间：Baseline and end of treatment (10-14 days)
|
Number of reflux episodes (pH 4.0-6.9)
based on 24-hour impedance monitoring data
|
Baseline and end of treatment (10-14 days)
|
|
Change From Baseline in Number of Non Acidic Reflux Episodes
大体时间：Baseline and end of treatment (10-14 days)
|
Number of reflux episodes (pH>=7.0)
based on 24-hour impedance monitoring data
|
Baseline and end of treatment (10-14 days)
|
|
Change From Baseline in Number of Liquid Acidic Reflux Episodes
大体时间：Baseline and end of treatment (10-14 days)
|
Number of reflux episodes based on 24-hour impedance monitoring data
|
Baseline and end of treatment (10-14 days)
|
|
Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes
大体时间：Baseline and end of treatment (10-14 days)
|
Number of reflux episodes based on 24-hour impedance monitoring data
|
Baseline and end of treatment (10-14 days)
|
|
Change From Baseline in Mean Bolus Clearance Time
大体时间：Baseline and end of treatment (10-14 days)
|
Based on 24-hour impedance monitoring data
|
Baseline and end of treatment (10-14 days)
|
|
Change From Baseline in Mean Acid Clearance Time
大体时间：Baseline and end of treatment (10-14 days)
|
Based on 24-hour impedance monitoring data
|
Baseline and end of treatment (10-14 days)
|
|
Change From Baseline in Percentage Time With pH<4.0
大体时间：Baseline and end of treatment (10-14 days)
|
Percentage time with pH<4 during 24-hour pH monitoring
|
Baseline and end of treatment (10-14 days)
|
|
Change From Baseline in Percentage Time With pH Within 4.0-6.9
大体时间：Baseline and end of treatment (10-14 days)
|
Percentage time with pH 4.0-6.9
during 24-hour pH monitoring
|
Baseline and end of treatment (10-14 days)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
调查人员
- 研究主任：Per Lundborg, MD、AstraZeneca
- 研究主任：Marta Illueca, MD、AstraZeneca
- 研究主任：Kathryn Collison, MPH, MT(ASCP)、AstraZeneca
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2006年10月1日
研究完成 (实际的)
2009年4月1日
研究注册日期
首次提交
2007年1月25日
首先提交符合 QC 标准的
2007年1月25日
首次发布 (估计)
2007年1月29日
研究记录更新
最后更新发布 (估计)
2010年12月20日
上次提交的符合 QC 标准的更新
2010年12月2日
最后验证
2010年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
胃食管反流病的临床试验
-
AstraZeneca完全的无糜烂性食管炎的 GERD瑞典, 美国, 法国, 意大利, 英国, 德国, 丹麦, 芬兰, 挪威, 加拿大
-
Aplos MedicalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes...招聘中