Effect of Proton Pump Inhibitor and Mosapride on Acid Pocket in Gastroesophageal Reflux Disease

Study Overview
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Brief Summary
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The gastric acid pocket is believed to be the reservoir from which acid reflux events originate. The risk for acidic reflux is mainly determined by the position of the gastric acid pocket. Little is known about how changes in position and size of the acid pocket contribute to the therapeutic effect of proton pump inhibitors(PPI) plus mosapride in patients with gastroesophageal reflux disease. Investigators will conduct a prospective randomized, single blind and placebo-controlled clinical trial to evaluate the hypothesis that mosapride affecting gastric motility might reduce gastro-esophageal reflux by changing the acid pocket position and size.

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: Administration of study drug (esomeprazole, mosapride)
* Drug: Administration of study drug (esomeprazole, placebo tablet)
* Procedure: upper endoscopy, scintigraphy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with diagnosed GERD(gastro-esophageal reflux disease), defined by the presence of oesophagitis obtained during a previous upper endoscopy or typical GERD symptoms(heartburn, acid reflux). Exclusion Criteria: who had organic gastrointestinal disease including inflammatory bowel disease, cancer and ulcer who took drugs which could affect evaluation of the treatment; other PPIs, H2RAs(H2 receptor antagonists), prokinetics,mucosal protective agents, antacids, cholinergic and anticholinergic agents, and antidepressants for at least 4 weeks prior to study start who had severe systemic diseases including hepatic and nephrotic disease who had previous gastrectomy history who was in state of pregnancy

Ages Eligible for Study
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Minimum Age: 18 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PPI + mosapride group<br>After diagnosis(GERD), patient of this group will be taken proton pump inhibitor (40mg) plus mosapride for 4weeks. After then, patient of this group will be undergo upper endoscopy and scintigraphy. | Drug: Administration of study drug (esomeprazole, mosapride)<br>* Esomeprazole(Hanxium®) 40 mg once daily and mosapride (Gasmotin®) 5 mg t.i.d for 4 weeks.<br>Procedure: upper endoscopy, scintigraphy<br>* After medication(4weeks), subjects will be undergo upper endoscopy and scintigraphy.<br>|
| Placebo Comparator: PPI + placebo group<br>After diagnosis(GERD), patient of this group will be taken proton pump inhibitor (40mg) plus placebo drug of mosapride for 4weeks. After then, patient of this group will be undergo upper endoscopy and scintigraphy. | Drug: Administration of study drug (esomeprazole, placebo tablet)<br>* Esomeprazole(Hanxium®) 40 mg once daily and placebo tablets that are identical to mosapride tablets t.i.d (3 times a day) for 4 weeks.<br>Procedure: upper endoscopy, scintigraphy<br>* After medication(4weeks), subjects will be undergo upper endoscopy and scintigraphy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size(cm2) of the acid pocket between PPI+placebo group and PPI+mosapride group | The size of the acid pocket will be determined by drawing an area of interest over the acid pocket in the proximal stomach in images(scintigraphy) taken at 10-minute intervals. | After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride) | 
| Location(cm) of the acid pocket between PPI+placebo group and PPI+mosapride group | Measurements of the distances between the acid pocket and the diaphragm will be make through a straight line in a planar posterior view of the stomach in images(scintigraphy) | After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of reflux symptom | Using RDQ(Reflux Disease Questionnaire) | After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride) |