Double-dose Rabeprazole Accelerates and Sustains the Control of Symptoms in Patients With NERD: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- symptom improvement at 2 week after double dose rabeprazole treatment
研究概览
简要总结
To the best of our knowledge, there has been no randomized controlled trial to compare double dose PPI therapy with standard one dose PPI therapy for NERD patients. Thus, we hypothesize that a double dose PPI would accelerate and sustain the control of symptom in NERD patients.
详细描述
In Asian, the majority of GERD cases are cases of nonerosive reflux esophagitis(NERD). NERD is a difficult -to-treat acid reflux condition even with PPI compared to reflux esophagitis(RE). In addition, the quality of life of NERD patients is quite low, NERD patients need quicker and more effective treatment options. At present, PPI-based step-down treatment is recommended for GERD patients. Doubling th PPI dose has become a commonly practiced therapeutic strategy in patients with GERD who failed PPI once daily. In patients with symptomatic GERD who failed the one dose PPI can increase the rate of overall symptom improvement by 22-26%. There are various mechanisms for standard dose PPI failure in GERD patients. Esophageal hypersensitivity is likely the underlying mechanism in a significant number of patients. Patients with the sensitive esophagus (normal endoscopy and pH test but positive symptom index) were more likely to respond to PPI twice a day. It is thus of clinical interest to determine whether an increased dosage of PPI can achieve rapidly the control of symptoms for patient with NERD patients.
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
- None
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
- •heartburn and/or reflux at least twice weekly in the absence of visible esophageal mucosal breaks at endoscopy
排除标准
- •pregnancy
- •lactation
- •Hx of gastric surgery
- •Hx of gastric cancer or peptic ulcer
- •major medical problems (including CHF, renal failure, COPD, asthma, liver cirrhosis)
- •severe systemic illness
- •Hx of malignancy, allergy Hx to rabeprazole
- •patients who had taken antibiotics
- •antisecretory agents including H2-blocker
- •PPI within 4 weeks before endoscopy
- •current usage of steroids, NSAIDs, aspirin, anticoagulant medication
研究组 & 干预措施
Double dose rabeprazole
Rabeprazole 20m bid per day will be given for 2 weeks
干预措施: rabeprazole (Drug)
standard dose rabeprazole
rabeprazole 20mg per day will bi given for 2 weeks
干预措施: standard dose rabeprazole (Drug)
结局指标
主要结局
symptom improvement at 2 week after double dose rabeprazole treatment
时间窗: Two weeks
symptom improvement according to FSSG(the frequency scale for the symptoms of GERD) at 2 week after double dose rabeprazole treatment
次要结局
- sustained symptom improvement at 6 week after treatment(6 weeks)