Treatment Response of High-dose and Standard-dose Rabeprazole for Extra-esophageal Reflux.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment Response of High-dose and Standard-dose Rabeprazole for Gastroesophageal Reflux Disease With Extra-esophageal Manifestations: a Single-center, Randomized, Open-label Trial.

Conditions
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Esophageal Disease

Intervention / Treatment
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* Drug: Rabeprazole 20mg bid
* Drug: Rabeprazole 20mg qd


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-dose rabeprazole<br>Rabeprazole 20mg twice daily by mouth before breakfast and dinner for 8 weeks | Drug: Rabeprazole 20mg bid<br>* Rabeprazole 20mg tablet b.i.d.<br>* Other names: Rabiet;|
| Active Comparator: Standard-dose rabeprazole<br>Rabeprazole 20mg once daily by mouth before breakfast for 8 weeks | Drug: Rabeprazole 20mg qd<br>* Rabeprazole 20mg tablet q.d.<br>* Other names: Rabiet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective improvement of symptoms | 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroesophageal Reflux