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

NCT02984930 | Unknown DMC

• 1 other identifier: 3-2016-0071
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Improvement of reflux symptom

  After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)

Study Arms (2)

PPI + mosapride group

EXPERIMENTAL

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); Procedure: upper endoscopy, scintigraphy

PPI + placebo group

PLACEBO COMPARATOR

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); Procedure: upper endoscopy, scintigraphy

Interventions

Administration of study drug (esomeprazole, mosapride) DRUG

Esomeprazole(Hanxium®) 40 mg once daily and mosapride (Gasmotin®) 5 mg t.i.d for 4 weeks.

PPI + mosapride group

Administration of study drug (esomeprazole, placebo tablet) DRUG

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.

PPI + placebo group

upper endoscopy, scintigraphy PROCEDURE

After medication(4weeks), subjects will be undergo upper endoscopy and scintigraphy.

PPI + mosapride group; PPI + placebo group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Esomeprazole; mosapride; Gastroscopy

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Hyojin Park, MD, PhD

CONTACT

82-2019-4624; gnocr@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Internal Medicine

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: December 7, 2016
• Study Start: December 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: December 7, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share