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

Yonsei University Health System (YUHS)

Status: Unknown

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: Administration of study drug (esomeprazole, placebo tablet); Procedure: upper endoscopy, scintigraphy; Drug: Administration of study drug (esomeprazole, mosapride)

Study type: Interventional

Funder types: Other

Identifiers

NCT02984930

3-2016-0071

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

30 participants in 2 patient groups, including a placebo group

PPI + mosapride group

Experimental group

Description:

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.

Treatment:

Drug: Administration of study drug (esomeprazole, mosapride)

Procedure: upper endoscopy, scintigraphy

PPI + placebo group

Placebo Comparator group

Description:

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.

Treatment:

Procedure: upper endoscopy, scintigraphy

Drug: Administration of study drug (esomeprazole, placebo tablet)