NCT00079833已完成3 期
A Phase III, Multicenter, Open-Label Study To Evaluate the Control of Gastric Acid Secretion With Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome For 12 Months
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
- 25
- 试验地点
- 9
- 主要终点
- To assess the gastric acid secretory rate at the final study visit.
研究概览
简要总结
This research study will determine if esomeprazole, when administered twice daily at 40, 80, or 120 mg doses, can control excessive stomach acid secretion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Males or females at least 18 years of age.
- •Diagnosis of Zollinger-Ellison Syndrome or idiopathic hypersecretion
排除标准
- •Pregnant or lactating females
- •History of drug addiction or alcohol abuse within 12 months prior to Screening.
- •History of intolerance to any proton pump inhibitors or any ingredient in their formulation.
结局指标
主要结局
To assess the gastric acid secretory rate at the final study visit.
Control is defined as gastric acid secretory rate below 10 mEq/h or below 5 meq/h for patients with prior gastric acid reducing Surgery
次要结局
- The status (controlled or not controlled) of gastric acid secretory rate at the Month 6 study visit.
- Control is defined as gastric acid secretory rate below 10 mEq/h or below 5 meq/h for patients with prior gastric acid reducing surgery.
- The following safety variables will be assessed at Month 6 and Month 12: adverse events, clinical laboratory results (ie, chemistry, hematology, urinalysis), physical examinations, and EGDs.
研究者
研究点 (9)
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