Comparison of the Percentage Chronic on-Demand Users Treated With 20 Mg Pantoprazole on-Demand and Placebo o.d Versus Placebo on-Demand and 20 Mg Pantoprazole o.d. After Symptom Relief With 20 Mg Pantoprazole o.d.
试验速览
- 阶段
- 3 期
- 发起方
- UMC Utrecht
- 入组人数
- 276
- 主要终点
- The percentage of patients taking 6 or more tablets on-demand per week (averaged from week 5-17.
研究概览
简要总结
The purpose of this study is to investigate several aspects of chronic use of acid suppressing medication: dependence on maintenance therapy, the possibilities for on-demand use, and predictors (patient characteristics) for daily need, for on-demand use and for termination of chronic use.
详细描述
2-5% of the general population is chronic user of acid suppressing medication (proton pump inhibitors, H2 receptor antagonists), mostly because of gastro-oesophageal reflux disease (GORD). Prescription data from health insurances show that the number of chronic users increases every year, which has large economic consequences.
There are indications however that on-demand and intermittent therapy can be as effective as daily use. No evidence exists regarding patients who are likely to benefit from intermittent, on-demand therapy or even termination.
In this study several aspects of chronic use of acid suppressive therapy are investigated in family practice patients.
Chronic users are transferred to pantoprazole 20 mg for 4 weeks. Patients with adequate relief of symptoms are randomized in two groups for a period of 13 weeks.
group 1: daily pantoprazole 20 mg, placebo on-demand (indicative for placebo-dependency) group 2: daily placebo, pantoprazole 20 mg on-demand (indicative for pharmacological dependency) Patients visit the research nurse at the beginning of the study and at week 4, 5, 10 and 17.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female (non-pregnant, non-lactating)out-patients between 18-75
- •chronic users of acid suppressive therapy for at least 180 days over the last year
排除标准
- •stage 3, 4 oesophagitis, Barrett's oesophagus, acute peptic ulcer
- •gastric hypersecretory condition, predominantly IBS symptoms, previous gastric/oesophageal surgery, pyloric stenosis
- •severe, unstable comorbidities
- •alarm symptoms
- •malignancies in the past 5 years
- •use of NSAID, systemic glucocorticoids, Cox-2 inhibitors, acetylsalicylic acid more than 150 mg daily, drugs with pH-dependent absorption, anticholinergics
结局指标
主要结局
The percentage of patients taking 6 or more tablets on-demand per week (averaged from week 5-17.
次要结局
- -mean weakly consumption of on-demand tablets
- -percentage of patients in placebo group requiring less than 2 tablets pantoprazole per week
- -proportion of patients with adequate relief per treatment group per week
- -quality of life during double-blind phase (via SF-36 and QOLRAD for GERD symptom score)
- -predictors of the primary outcome (age, sex, general medical and gastrointestinal history, Hp status, BMI, lifestyle factors, personality and psychological state)
- -proportion of patients successfully changed from omeprazole to pantoprazole, or from 40 mg to 20 mg
- -costs during all phases
- -cost-effectiveness