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临床试验/NCT00256737
NCT00256737已完成3 期

Omeprazole Versus Anti-reflux Surgery in the Long-term Management of Peptic Esophagitis - a 10 Year Follow up Study of Patients Previously Studied for 5 Years - A Nordic Multicentre Study

AstraZeneca13 个研究点 分布在 4 个国家目标入组 219 人开始时间: 1998年1月最近更新:
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
219
试验地点
13
主要终点
Determine the safety of omeprazole during long term treatment

研究概览

简要总结

The purpose of this study is to study gastritis, GI symptoms during long term omeprazole treatment

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Previous inclusion into Astra study I-635 and willing to continue for another 10 years,

排除标准

  • Pregnancy or lactation; Woman planning pregnancy within 5 years; Suspected or confirmed malignancy; Documented eradication of Helicobacter pylori.

结局指标

主要结局

Determine the safety of omeprazole during long term treatment

次要结局

  • To investigate the long term control of reflux symptoms, healing of esophagitis and persistence of post fundoplication symptoms during long term treatment of omeprazole

研究者

发起方
AstraZeneca
申办方类型
Industry

研究点 (13)

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