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

NCT ID: NCT02984930

Last Updated: 2016-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-07-31

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.

Detailed Description

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Conditions

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Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Administration of study drug (esomeprazole, mosapride)

Intervention Type DRUG

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

upper endoscopy, scintigraphy

Intervention Type PROCEDURE

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

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.

Group Type PLACEBO_COMPARATOR

Administration of study drug (esomeprazole, placebo tablet)

Intervention Type 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.

upper endoscopy, scintigraphy

Intervention Type PROCEDURE

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

Interventions

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Administration of study drug (esomeprazole, mosapride)

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

Intervention Type 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.

Intervention Type DRUG

upper endoscopy, scintigraphy

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyojin Park

Department of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Hyojin Park, MD, PhD

Role: CONTACT

Phone: 82-2019-4624

Email: [email protected]

Other Identifiers

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3-2016-0071

Identifier Type: -

Identifier Source: org_study_id