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

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.

Study Overview

• Status: Unknown
• Conditions: Gastroesophageal Reflux Disease
• Intervention / Treatment: Drug: Administration of study drug (esomeprazole, mosapride); Procedure: upper endoscopy, scintigraphy; Drug: Administration of study drug (esomeprazole, placebo tablet)

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hyojin Park, MD, PhD; Phone Number: 82-2019-4624; Email: gnocr@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PPI + mosapride group; 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); Esomeprazole(Hanxium®) 40 mg once daily and mosapride (Gasmotin®) 5 mg t.i.d for 4 weeks.; Procedure: upper endoscopy, scintigraphy; After medication(4weeks), subjects will be undergo upper endoscopy and scintigraphy.
Placebo Comparator: PPI + placebo group; 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.	Procedure: upper endoscopy, scintigraphy; After medication(4weeks), subjects will be undergo upper endoscopy and scintigraphy.; Drug: Administration of study drug (esomeprazole, placebo tablet); 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): July 1, 2018

Study Registration Dates

• First Submitted: August 23, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (Estimate): December 7, 2016

Study Record Updates

• Last Update Posted (Estimate): December 7, 2016
• Last Update Submitted That Met QC Criteria: December 6, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Serotonin Agents; Serotonin Receptor Agonists; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole; Mosapride
• Other Study ID Numbers: 3-2016-0071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No