Treatment Response of Maintenance Dose of Proton Pump Inhibitor in Patients With Nonerosive Gatroesophageal Reflux Disease

Study Overview
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Brief Summary
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For ERD(erosive reflux disease), which pathogenesis is mainly the acid reflux mechanism, primary treatment is therefore PPI. However, NERD(non-erosive reflux disease) is much more complex than ERD and there are more factors causing the typical symptoms. As a result, there is no consensus for the treatment of NERD besides using PPI similar to GERD(gastroesophageal reflux diseas). This study intent to evaluate the effect of PPI(Esomezol) on NERD patients and analyze the improvement of symptoms and the factors related to the result.

Detailed Description
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(1) Among GERD patients, EGD(esophagogastroduodenoscopy) must be done before 6 months and must prove there is no erosive lesion. (2) During EGD, esophagus mucosa histology will be taken for evaluation. (3) For NERD patients, Esomezol is given once a day (before breakfast meal), for whole 8 weeks. (4) PAGI-SYM and HAD-K is evaluated and score just before the administration of PPI, 4weeks after and 8weeks after the study initiation.

Official Title
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Treatment Response of Maintenance Dose of Proton Pump Inhibitor in Patients With Nonerosive Gatroesophageal Reflux Disease

Conditions
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Non-erosive Gatroesophageal Reflux Disease

Intervention / Treatment
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* Drug: PPI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient over 19 years old Patient with typical GERD symptom (heartburn or acid reflux more than once a week) Exclusion Criteria: Patient who received EGD since the past 6 months, and diagnosed as GERD endoscopically Patient with active gastric/duodenal ulcer Patient who received esophagus, stomach or duodenum surgery Patient with hypersensitivity to esomezol® Patient with no achieved agreement on the study from the guardian or patient himself.

Ages Eligible for Study
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Minimum Age: 19 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
Intervention Model: Single Group Assignment
Interventional Model Description: There is only one arm in this study. Patients diagnosed as NERD will take PPI (Esomezol) for 8 weeks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PPI<br>Esomezol® | Drug: PPI<br>* After the diagnosis of NERD through patient's symptom and endoscopy, PPI (esomezol) will be given for 8 weeks. The effect of PPI for NERD patients will be analyzed.<br>* Other names: Esomezol®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of PAGI-SYM score (0-2) patients after 8 weeks of PPI(Esomezol) | Scoring the PAGI-SYM to analyze the satisfaction of symptoms (heartburn and regurgitation) after 8 weeks of PPI administration to NERD patients | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The analysis of factors affecting the PAGI-SYM inculding immunolgic array and esophagus mucosal microbiota | The analysis of complete symptom (regurgitation, heartburn) remission (PAGI-SYM score 0) after 8weeks of PPI | 8 weeks |