NCT00641602已完成4 期
A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis.
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
- 1,000
- 主要终点
- To compare the difference in healing rates of erosive esophagitis (EE) between esomeprazole 40 mg qd (E40) and lansoprazole 30 mg qd (L30) in patients with moderate or severe EE, defined as Grade C or D in the Los Angeles (LA) Classification scale.
研究概览
简要总结
This study looks at the healing rates in patients with Erosive Esophagitis (EE) when treated with either esomeprazole or lansoprazole
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Episodes of heartburn (described as a burning feeling, rising from the stomach or lower part of the chest up towards the neck) for 2 days or more during the last 7 days prior to baseline.
- •Confirmed Erosive Esophagitis within 1 week prior to starting the study.
排除标准
- •Any signs of gastrointestinal bleeding at the time of the starting the study.
- •Any previous gastric or esophageal surgery.
- •Various gastrointestinal diseases as listed in the protocol.
研究组 & 干预措施
1
Experimental
Nexium
干预措施: Esomeprazole (Drug)
2
Active Comparator
Prevacid
干预措施: Lansoprazole (Drug)
结局指标
主要结局
To compare the difference in healing rates of erosive esophagitis (EE) between esomeprazole 40 mg qd (E40) and lansoprazole 30 mg qd (L30) in patients with moderate or severe EE, defined as Grade C or D in the Los Angeles (LA) Classification scale.
时间窗: Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4)
次要结局
- 1. To compare the difference in the resolution of, and relief of, the investigator evaluated GERD symptoms of heartburn, acid regurgitation, dysphagia, and epigastric pain between E40 and L30 at week 4 of treatment in patients with moderate or severe EE.(Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4))
- To evaluate safety and tolerability of E40 compared to that of L30 in patients with moderate or severe EE.(Adverse event collection on an ongoing basis)
- 1. To compare the difference between E40 and L30 in the occurrence of heartburn symptoms as reported in the patient's daily diary.(Dairy card to be completed by patient daily)
研究者
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