Treatment Response of High-dose and Standard-dose Rabeprazole for Extra-esophageal Reflux.
- Conditions
- Esophageal Disease
- Interventions
- Registration Number
- NCT04001400
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 73
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard-dose rabeprazole Rabeprazole 20mg qd Rabeprazole 20mg once daily by mouth before breakfast for 8 weeks High-dose rabeprazole Rabeprazole 20mg bid Rabeprazole 20mg twice daily by mouth before breakfast and dinner for 8 weeks
- Primary Outcome Measures
Name Time Method Effective improvement of symptoms 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Seoul National University Bungdang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of