<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02984930</url>
  </required_header>
  <id_info>
    <org_study_id>3-2016-0071</org_study_id>
    <nct_id>NCT02984930</nct_id>
  </id_info>
  <brief_title>Effect of Proton Pump Inhibitor and Mosapride on Acid Pocket in Gastroesophageal Reflux Disease</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gangnam Severance Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gangnam Severance Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The gastric acid pocket is believed to be the reservoir from which acid reflux events&#xD;
      originate. The risk for acidic reflux is mainly determined by the position of the gastric&#xD;
      acid pocket. Little is known about how changes in position and size of the acid pocket&#xD;
      contribute to the therapeutic effect of proton pump inhibitors(PPI) plus mosapride in&#xD;
      patients with gastroesophageal reflux disease. Investigators will conduct a prospective&#xD;
      randomized, single blind and placebo-controlled clinical trial to evaluate the hypothesis&#xD;
      that mosapride affecting gastric motility might reduce gastro-esophageal reflux by changing&#xD;
      the acid pocket position and size.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Size(cm2) of the acid pocket between PPI+placebo group and PPI+mosapride group</measure>
    <time_frame>After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Location(cm) of the acid pocket between PPI+placebo group and PPI+mosapride group</measure>
    <time_frame>After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)</time_frame>
    <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)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of reflux symptom</measure>
    <time_frame>After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)</time_frame>
    <description>Using RDQ(Reflux Disease Questionnaire)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Gastroesophageal Reflux Disease</condition>
  <arm_group>
    <arm_group_label>PPI + mosapride group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PPI + placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Administration of study drug (esomeprazole, mosapride)</intervention_name>
    <description>Esomeprazole(Hanxium®) 40 mg once daily and mosapride (Gasmotin®) 5 mg t.i.d for 4 weeks.</description>
    <arm_group_label>PPI + mosapride group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Administration of study drug (esomeprazole, placebo tablet)</intervention_name>
    <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.</description>
    <arm_group_label>PPI + placebo group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>upper endoscopy, scintigraphy</intervention_name>
    <description>After medication(4weeks), subjects will be undergo upper endoscopy and scintigraphy.</description>
    <arm_group_label>PPI + mosapride group</arm_group_label>
    <arm_group_label>PPI + placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with diagnosed GERD(gastro-esophageal reflux disease), defined by the&#xD;
             presence of oesophagitis obtained during a previous upper endoscopy or typical GERD&#xD;
             symptoms(heartburn, acid reflux).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  who had organic gastrointestinal disease including inflammatory bowel disease, cancer&#xD;
             and ulcer&#xD;
&#xD;
          -  who took drugs which could affect evaluation of the treatment; other PPIs, H2RAs(H2&#xD;
             receptor antagonists), prokinetics,mucosal protective agents, antacids, cholinergic&#xD;
             and anticholinergic agents, and antidepressants for at least 4 weeks prior to study&#xD;
             start&#xD;
&#xD;
          -  who had severe systemic diseases including hepatic and nephrotic disease&#xD;
&#xD;
          -  who had previous gastrectomy history&#xD;
&#xD;
          -  who was in state of pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hyojin Park, MD, PhD</last_name>
    <phone>82-2019-4624</phone>
    <email>gnocr@yuhs.ac</email>
  </overall_contact>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 6, 2016</last_update_submitted>
  <last_update_submitted_qc>December 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gangnam Severance Hospital</investigator_affiliation>
    <investigator_full_name>Hyojin Park</investigator_full_name>
    <investigator_title>Department of Internal Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <mesh_term>Esophagitis, Peptic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esomeprazole</mesh_term>
    <mesh_term>Mosapride</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02984930
org study id: 3-2016-0071
nct id: NCT02984930
lead sponsor: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Size(cm2) of the acid pocket between PPI+placebo group and PPI+mosapride group
time frame: After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)
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.
measure: Location(cm) of the acid pocket between PPI+placebo group and PPI+mosapride group
time frame: After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)
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)
measure: Improvement of reflux symptom
time frame: After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride)
description: Using RDQ(Reflux Disease Questionnaire)
arm group label: PPI + mosapride group
arm group type: Experimental
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 group label: PPI + placebo group
arm group type: Placebo Comparator
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: Administration of study drug (esomeprazole, mosapride)
description: Esomeprazole(Hanxium®) 40 mg once daily and mosapride (Gasmotin®) 5 mg t.i.d for 4 weeks.
arm group label: PPI + mosapride group
intervention type: Drug
intervention name: Administration of study drug (esomeprazole, placebo tablet)
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.
arm group label: PPI + placebo group
intervention type: Procedure
intervention name: upper endoscopy, scintigraphy
description: After medication(4weeks), subjects will be undergo upper endoscopy and scintigraphy.
arm group label: PPI + mosapride group
arm group label: PPI + placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Hyojin Park, MD, PhD
phone: 82-2019-4624
email: gnocr@yuhs.ac
responsible party type: Principal Investigator
investigator affiliation: Gangnam Severance Hospital
investigator full name: Hyojin Park
investigator title: Department of Internal Medicine
mesh term: Gastroesophageal Reflux
mesh term: Esophagitis, Peptic
mesh term: Esomeprazole
mesh term: Mosapride
sharing ipd: No