NCT00251927已完成3 期
An Open, Randomized, Multicenter, Phase IIIB Study During 5 Years to Assess Long-term Efficacy and Tolerability of Esomeprazole Compared to Laparoscopic Anti-reflux Surgery in Adult Subjects With Gastroesophageal Reflux Disease - LOTUS.
适应症
干预措施
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
- 626
- 试验地点
- 1
- 主要终点
- Number of Participants With Treatment Failure at 5 Years
研究概览
简要总结
The study investigates the efficacy of long-term treatment of esomeprazole compared to anti-reflux surgery in the control of gastroesophageal reflux disease by assessing time to treatment failure.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects considered suitable for surgical treatment and long-term management of esomeprazole.
- •History of chronic reflux esophagitis or symptomatic GERD
排除标准
- •History of esophageal, gastric, or duodenal surgery predicted to influence negatively on subsequent treatment within the study.
- •Contraindication to the study drug.
- •Pregnancy, lactating or of child-bearing potential.
研究组 & 干预措施
1
Active Comparator
Surgery
干预措施: Laparoscopic fundoplication (surgery) (Procedure)
2
Experimental
Esomeprazole (NEXIUM) therapy
干预措施: esomeprazole (Drug)
结局指标
主要结局
Number of Participants With Treatment Failure at 5 Years
时间窗: During 5 years
Treatment failure in the surgical arm defined when need for medical treatment for control of symptoms from reflux disease. Treatment failure in the medical arm defined when need for treatment other than esomeprazole for control of symptoms of reflux disease.
次要结局
- Los Angeles (LA) Grade 'Normal' at 5 Year Visit(At 5 year visit)
- Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With no Heartburn(At 5 year visit)
- Total Score for Microscopic Reflux-related Changes in the Distal Esophagus 2 cm Above the Z-line, at 5 Year Visit(At 5 year visit)
- Percentage Time With pH<4 During 24-hour pH Metry at 5 Year Visit(At 5 year visit)
- Los Angeles (LA) Grade 'A' at 5 Year Visit(At 5 year visit)
- Los Angeles (LA) Grade 'B' at 5 Year Visit(At 5 year visit)
- Los Angeles (LA) Grade C at 5 Year Visit(At 5 year visit)
- Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Mild Heartburn(At 5 year visit)
- Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Moderate Heartburn(At 5 year visit)
- Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Severe Heartburn(At 5 year visit)
研究者
研究点 (1)
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