Long-Term Study of the Efficacy and Safety of Lansoprazole in the Treatment of Zollinger-Ellison and Other Acid Hypersecretors
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 主要终点
- Long-term Medical(Non-surgical)Control of Gastric Acid Production Assessed From Time of Study Enrollment, up to 240 Months Post Enrollment.
研究概览
简要总结
The purpose of this study is to study the safety and efficacy of high dose Prevacid in the long-term treatment of patients who secrete abnormally large amounts of gastric acid.
详细描述
The aim of this protocol is to study the medical management of acid hypersecretory states including Zollinger-Ellison using Prevacid. The immediate objective is to heal peptic ulcers and eliminate symptoms and in the long term to prevent relapse of symptoms, lesions and complications. Other objectives include observation of the efficacy in controlling gastric acid production and of the safety of high dose, long-term use of Prevacid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Zollinger-Ellison syndrome
排除标准
- •Pregnant or lactating females
研究组 & 干预措施
single group
This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
干预措施: Lansoprazole (Prevacid) (Drug)
结局指标
主要结局
Long-term Medical(Non-surgical)Control of Gastric Acid Production Assessed From Time of Study Enrollment, up to 240 Months Post Enrollment.
时间窗: up to 240 months from study enrollment
number of participants with control of gastric acid production
次要结局
- The Median Survival From the Time of Diagnosis.(survival or up to 240 months)
研究者
Charles Mel Wilcox, MD
Prinicle Investigator
University of Alabama at Birmingham