Proton Pump Inhibitor Treatment Stop: Discontinuation of Acid-suppressive Medication Among Long-term Users in a Primary Health Care Setting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Failure of patient perceived symptom control despite treatment with project medication
研究概览
简要总结
The purpose of this study is to determine how many chronic users of antisecretory medication can stop after a test for a bacteria associated with peptic ulcer disease.
This is evaluated in a discontinuation trial.
详细描述
Background:
Testing patients with a Helicobacter pylori (Hp) 13C-urea breath test and treatment with eradication of Hp if positive - test-and-eradicate - have proven as effective and safe as prompt endoscopy for management of dyspeptic patients in a primary health care setting. However, empirical treatment with an ulcer-healing drug is often used in dyspeptic patients, as reflected in a growing proportion of long-term users without known ulcer or gastro-oesophageal reflux disease (GORD). This group of patients contributed to 59% of the total use of acid-suppressive medication in the County of Funen in Denmark in 1997.
Aim/purpose:
It is our aim to examine the need for continued medication with prescribed, acid-suppressive drugs in primary health care.
Our secondary objective is to investigate the profile of symptoms, quality of life, Hp-status, consumption of drugs and use of health care services in the same context.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Use of antisecretory medication for more than 2 months during the last 6 months
排除标准
- •Malignity or severe, competing medical or psychiatric disease
- •Esophagitis (proven by endoscopy)
- •Prior complication to peptic ulcer disease
- •Alarm symptoms
- •Pregnancy or lactation
- •Allergy towards esomeprazole
- •Planned hospitalisation during study period
研究组 & 干预措施
esomeprazole
Long-term users continue antisecretory medication
干预措施: esomeprazole (Drug)
esomeprazole
Long-term users continue antisecretory medication
干预措施: Helicobacter pylori c-13 breath test (Procedure)
placebo drug
Long-term users are treated with placebo
干预措施: esomeprazole (Drug)
placebo drug
Long-term users are treated with placebo
干预措施: Helicobacter pylori c-13 breath test (Procedure)
结局指标
主要结局
Failure of patient perceived symptom control despite treatment with project medication
时间窗: 12 months
次要结局
- Gastrointestinal symptoms(12 months)
- Quality of life(12 months)
- GPs and patients satisfaction(12 months)
- Helicobacter pylori status(At enrolement)
- Resource consumption(12 months)
- Days without symptoms(12 months)
- Use of otc-medication(12 months)
- Sick-leave days(12 months)
- Number of visits to primary and secondary healthcare system(12 months)