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

Primary Purpose

Gastroesophageal Reflux Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Administration of study drug (esomeprazole, mosapride)
Administration of study drug (esomeprazole, placebo tablet)
upper endoscopy, scintigraphy
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    PPI + mosapride group

    PPI + placebo group

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.
    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)

    Secondary Outcome Measures

    Improvement of reflux symptom
    Using RDQ(Reflux Disease Questionnaire)

    Full Information

    First Posted
    August 23, 2016
    Last Updated
    December 6, 2016
    Sponsor
    Gangnam Severance Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02984930
    Brief Title
    Effect of Proton Pump Inhibitor and Mosapride on Acid Pocket in Gastroesophageal Reflux Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    July 2018 (Anticipated)
    Study Completion Date
    July 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Gangnam Severance Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastroesophageal Reflux Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    PPI + mosapride group
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    PPI + placebo group
    Arm Type
    Placebo Comparator
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Administration of study drug (esomeprazole, mosapride)
    Intervention Description
    Esomeprazole(Hanxium®) 40 mg once daily and mosapride (Gasmotin®) 5 mg t.i.d for 4 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Administration of study drug (esomeprazole, placebo tablet)
    Intervention Description
    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
    Procedure
    Intervention Name(s)
    upper endoscopy, scintigraphy
    Intervention Description
    After medication(4weeks), subjects will be undergo upper endoscopy and scintigraphy.
    Primary Outcome Measure Information:
    Title
    Size(cm2) of the acid pocket between PPI+placebo group and PPI+mosapride group
    Description
    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.
    Time Frame
    After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)
    Title
    Location(cm) of the acid pocket between PPI+placebo group and PPI+mosapride group
    Description
    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)
    Time Frame
    After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)
    Secondary Outcome Measure Information:
    Title
    Improvement of reflux symptom
    Description
    Using RDQ(Reflux Disease Questionnaire)
    Time Frame
    After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hyojin Park, MD, PhD
    Phone
    82-2019-4624
    Email
    gnocr@yuhs.ac

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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