With-Drawal Study of Proton-Pump-Inhibitors in Patients From Primary Care Who Have Previously Been Treated on a Long-Term Basis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Comparison of the effect of treatment in one week with esomeprazole and placebo measured as symptomscore in patientdiary.
研究概览
简要总结
The primary purpose of the study is to determine the effect of esomeprazole compared to placebo in patients from general practice who have previously been treated with proton-pump-inhibitors (PPI) and who have no upper endoscopic findings.
详细描述
The majority of patients with dyspepsia are treated in primary care with acid-suppressive therapy for shorter or longer periods of time on the assumption that the patients´ symptoms are related to the production of acid in the stomach.
In about half of the dyspeptic patients there is no structural or biochemical explanation for their symptoms. These patients suffer from functional dyspepsia.
Treatment with proton-pump-inhibitors is effective in treating patients with gastroesophageal refluxdisease or ulcers. It is however controversial if acid-suppressive treatment is effective in the large group of patients with functional dyspepsia. Previous studies have shown no or very modest effect with a very high placeboresponse rate of 40-50%.
In primary care patients with upper abdominal symptoms are often treated with PPI as a diagnostic tool. If the treatment is effective continued or repeated treatment with PPI is often favored. However some of the patients must experience the abovementioned placebo-effect. These patients may end up being treated with PPI long-term on uncertain indication.
We wish to investigate the consequences of withdrawing treatment with PPI in patients from general practice who have previously been treated long-term.
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
- Double
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
- •Treatment with PPI in at least 4 months out of the preceding
- •Use of PPI in the preceding 10 out of 30 days before inclusion
- •Age above 18 years
排除标准
- •Erosive Esophagitis
- •PPI-treatment as prophylaxis against gastrointestinal bleeding
- •PPI-treatment as prophylaxis against ulcers
- •PPI-treatment as prophylaxis because of NSAID-treatment
- •Pregnant or lactating women
- •Previous upper GI surgery
结局指标
主要结局
Comparison of the effect of treatment in one week with esomeprazole and placebo measured as symptomscore in patientdiary.
次要结局
- Fraction of patients who are willing to withdraw treatment with PPI
- Fraction of patients who experience symptoms after withdrawal of treatment.
- Description of endoscopic findings in patients who have previously been treated with PPI long-term and who after withdrawal are symptomatic
- Length of time from withdrawal till symptoms arise
- Correlation between levels of gastrin and CgA and time till symptoms arise
- Investigators and patients ability to distinguish between active and placebo treatment