Treatment Response of High-dose and Standard-dose Rabeprazole for Gastroesophageal Reflux Disease With Extra-esophageal Manifestations: a Single-center, Randomized, Open-label Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Effective improvement of symptoms
研究概览
简要总结
This is a single-center, randomized, open-label clinical study to assess the treatment response of high-dose rabeprazole compared with standard-dose rabeprazole in patients with extra-esophageal manifestations of gastroesophageal reflux disease.
详细描述
Gastroesophageal reflux disease is a condition in which reflux of stomach contents into the esophagus. This disease can be classified in to two subtypes according to the symptoms; Typical symptoms such as heartburn and regurgitation, and atypical symptoms (extra-esophageal symptoms) such as chronic cough, asthma, non-cardiac chest pain, globus sensation, etc.
Acid suppression with proton pump inhibitors is the mainstream of therapy for the extra-esophageal manifestation as well as the typical symptoms of gastroesophageal reflux disease.
However, there is controversy about the efficacy of proton pump inhibitors on extra-esophageal reflux.
Therefore, we aimed to assess the effect of proton pump inhibotor (rabeprazole) on the extra-esophageal manifestation of gastroesophageal reflux disease, through comparison of treatment response with high-dose and standard-dose rabeprazole.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age is over 20 years old, under 80 years old, men or women
- •Patients who had experienced extra-esophageal symptoms of gastroesophageal reflux disease more than once a week within the last month prior to the start of the study
排除标准
- •Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 4 weeks
- •Patients administered with anti-thrombotic drugs
- •Patients taking other investigational drugs or participating in other clinical studies in 4 weeks
- •Patients with esophageal stricture, esophageal varix, Barrett's esophagus, peptic ulcer or gastrointestinal bleeding
- •Patients with Zollinger-Ellison syndrome
- •Patients with any kind of malignant tumor
- •Patients with surgery related to gastroesophageal
- •Patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease
- •Patients with neuropsychiatric disorder, alcoholism, or drug abuse
- •Women either pregnant or breast feeding
研究组 & 干预措施
High-dose rabeprazole
Rabeprazole 20mg twice daily by mouth before breakfast and dinner for 8 weeks
干预措施: Rabeprazole 20mg bid (Drug)
Standard-dose rabeprazole
Rabeprazole 20mg once daily by mouth before breakfast for 8 weeks
干预措施: Rabeprazole 20mg qd (Drug)
结局指标
主要结局
Effective improvement of symptoms
时间窗: 8 weeks
A percentage of subjects showed effective improvement of extra-esophageal symptoms of gastroesophageal reflux disease by assessing the average sum of the questionnaire symptom scores. The definition of "effective improvement" is the subjects showed ≥50% reduction from the initial questionnaire score. The symptom questionnaire consists of a 5-graded Likert scale for each symptom to assess intensity of symptoms. \[score 0: no symptoms, score 1: mild symptoms that is not easily felt, score 2: moderate symptoms but not affect daily life, score 3: severe symptoms that hinder daily life or sleep, score 4: very severe symptoms that cannot lead to normal daily life or sleep\] In this trial, extra-esophageal symptoms consist of eight symptoms; non-cardiac chest pain, cough, globus, wheezing, laryngopharyngitis, hoarseness, belching and dysphagia.
次要结局
未报告次要终点
研究者
Dong Ho Lee
Director, Clinical Research
Seoul National University Hospital