跳至主要内容
临床试验/NCT00261300
NCT00261300已完成3 期

Long-term Pantoprazole Trial in Patients With Symptoms of Chronic Acid Peptic Complaints

Takeda1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2000年10月最近更新:
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
入组人数
100
试验地点
1
主要终点
Safety (adverse events, laboratory values).

研究概览

简要总结

Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD might occur when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting reflux symptoms. One of the main symptoms of GERD is heartburn. It occurs when the acidic content from the stomach touches the lining of the esophagus, causing a burning sensation in the chest or throat. Proton pump inhibitors such as pantoprazole can relieve symptoms of GERD and peptic ulcers in a large proportion of patients.

Additionally, long-term treatment with proton pump inhibitors may be needed for patients with chronic ulcer disease not caused by H. pylori (H. pylori is a stomach-dwelling bacteria which is often associated with ulcers in the stomach or duodenum).

The aim of the study is to evaluate the long-term effect of pantoprazole in patients with chronic gastric acid-related complaints. The study duration consists of a 5-year treatment period. Pantoprazole will be administered once daily. The study will provide further data on long-term safety, tolerability, and efficacy of pantoprazole.

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

性别
All
接受健康志愿者

入选标准

  • Patients who completed ALTANA Pharma study BY1023/FK3006 (long-term clinical trial regarding efficacy and tolerability of Pantoprazole in patients not responding to treatment with H2-receptor antagonists or omeprazole)
  • Written informed consent

排除标准

  • Concomitant diseases
  • Pregnant or nursing female patients; female patients of childbearing potential who are not using reliable contraception

研究组 & 干预措施

1

Experimental

Pantoprazole 40 mg

干预措施: Pantoprazole (Drug)

结局指标

主要结局

Safety (adverse events, laboratory values).

时间窗: 5 years

次要结局

  • Evaluation of gastrointestinal symptoms, histological parameters.(5 years)

研究者

发起方
Takeda
申办方类型
Industry

研究点 (1)

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