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

Gastroesophageal Reflux Disease Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02984930
• Other study ID #: 3-2016-0071
• Status: Not yet recruiting
• Phase: N/A
• First received: August 23, 2016
• Last updated: December 6, 2016
• Start date: December 2016
• Est. completion date: July 2018

Study information

• Verified date: August 2016
• Source: Gangnam Severance Hospital
• Contact: Hyojin Park, MD, PhD
• Phone: 82-2019-4624
• Email: gnocr[@]yuhs.ac
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Administration of study drug (esomeprazole, mosapride)
Esomeprazole(Hanxium®) 40 mg once daily and mosapride (Gasmotin®) 5 mg t.i.d for 4 weeks.
• 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.

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	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)	No
Secondary	Improvement of reflux symptom	Using RDQ(Reflux Disease Questionnaire)	After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)	No