Omeprazole and Reflux Disease - Improvement of Clinical Outcome by Genotype-adjusted Dosing
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- endoscopic healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole (according to metabolic capacity of the patient)
研究概览
简要总结
Patients with gastroesophageal reflux disease (GERD) are either treated for 4 weeks with a standard dose (20mg) of omeprazole, a drug of first choice, or by an individualized dosing (20 or 60mg/day) according how fast the patient can metabolize (eliminate) the drug. The individual elimination capacity is genetically controlled and therefore all patients will be genotyped prior to therapy.
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
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with GERD grade A and B (mild to moderate severe disease) diagnosed by routine endoscopy will be recruited in different clinical and ambulant centres of gastroenterology; written informed consent is obligatory
- •Range of Age: 20-70
- •BMI: 20-30
排除标准
- •Patients who are allergic to proton-pump inhibitors or show incompatibility
- •Patients who have lactase deficiency
- •Patients who have severe chronic disease
- •Patients who participated in another study during the last three months
- •Patients who are pregnant
研究组 & 干预措施
control group
3 tablets, only 20 mg omeprazole, genotype independent
干预措施: omeprazole (Drug)
intervention group
20 vs. 60 mg daily, genotype dependent
干预措施: omeprazole (Drug)
结局指标
主要结局
endoscopic healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole (according to metabolic capacity of the patient)
时间窗: 4 weeks
次要结局
- clinical healing rate in patients with GERD after 4 weeks of individualised dosing of omeprazole(4 weeks)
研究者
Matthias Schwab
MD
Robert Bosch Gesellschaft für Medizinische Forschung mbH