NCT00734097已完成4 期
An Open Label, Multicentre Study of Nexium (Esomeprazole) 40 mg Once Daily in Subjects With Symptoms of Gastroesophageal Reflux Disease (GORD) After Treatment With a Full Dose of Proton Pump Inhibitor (PPI)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 314
- 试验地点
- 1
- 主要终点
- Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment
研究概览
简要总结
The purpose of this study is to assess how patients with gastro-oesophageal reflux disease (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still experiencing symptoms will benefit from a change in treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persisting symptoms of GORD despite previous treatment with a full dose proton pump inhibitor
- •informed consent
- •over 18 years of age
排除标准
- •Current course of Proton Pump inhibitor treatment for more than 8 weeks prior to enrolment in the study
- •More than 1 other course of PPI treatment in the previous 12 month
- •previous use of esomeprazole
- •presence of alarm symptoms
研究组 & 干预措施
Nexium 40 mgs
Experimental
干预措施: Esomeprazole 40 mg (Drug)
Nexium 40 mgs
Experimental
干预措施: Physical Exam (Procedure)
Nexium 40 mgs
Experimental
干预措施: Quality of Life Questionnaires (Other)
Nexium 40 mgs
Experimental
干预措施: pregnancy test, if applicable (Procedure)
结局指标
主要结局
Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment
时间窗: At Baseline and 8 weeks
Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline
次要结局
- Change in Frequency of Epigastric Pain After 8 Weeks of Treatment(At Baseline and 8 weeks)
- Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment(At Baseline and 4 weeks)
- Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment(At Baseline and 8 weeks)
- Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment(At Baseline and 4 weeks)
- Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment.(At Baseline and 4 weeks.)
- Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment.(At Baseline and 8 weeks.)
- Change in Frequency of Epigastric Pain After 4 Weeks of Treatment(At Baseline and 4 weeks)
- Change in Severity of Epigastric Pain After 8 Weeks of Treatment(At Baseline and 8 weeks)
- Change in Severity of Epigastric Pain After 4 Weeks of Treatment(At Baseline and 4 weeks)
- Change in Severity of Acid Regurgitation After 8 Weeks of Treatment(At Baseline and 8 weeks)
- Change in Severity of Acid Regurgitation After 4 Weeks of Treatment(At Baseline and 4 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
PPI Sequencing StudyGastro-Oesophageal Reflux DiseaseNCT00384592AstraZeneca100
已完成
不适用
Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux DiseaseGastroesophageal Reflux DiseaseNCT01432392AstraZeneca1,000
已完成
3 期
A Study of E3810 With Pre- and Post-Treatment pH Monitoring in Patients With Non-Erosive Gastroesophageal Reflux DiseaseNon-erosive Gastroesophageal Reflux DiseaseNCT00165672Eisai Inc.26
已完成
不适用
Survey Examining the Frequency and Severity of Acid Related Symptoms While Taking NexiumGastric Acid SuppressionProton Pump InhibitorsNCT01130935AstraZeneca491
招募中
不适用
Study protocol: gastroesopahgeal reflux disease after N-sleeve versus Roux-en-Y gastric bypass (GINSBY): a randomised controlled trial.GERD, morbidly obeseNL-OMON27603-88