<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/NCT04493125</url>
  </required_header>
  <id_info>
    <org_study_id>3-2020-0175</org_study_id>
    <nct_id>NCT04493125</nct_id>
  </id_info>
  <brief_title>The Effect of Mosapride Citrate on Gastrointestinal Motility After Gastrectomy: Prospective, Double Blind Placebo-controlled Study</brief_title>
  <official_title>The Effect of Mosapride Citrate on Gastrointestinal Motility After Gastrectomy:</official_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>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      &quot;Mosapride citrate is a 5-hydroxytryptamine 4 receptor agonist, and is widely used as an&#xD;
      agent to increase intestinal motility. Mosapride citrate has been demonstrated in in vitro&#xD;
      and in vivo studies to increase both gastric and colon motility. In a case-control study of&#xD;
      patients undergoing colonectomy, mosapride citrate was found to significantly reduce gas&#xD;
      passing and defecation time.&#xD;
&#xD;
      Recently, a study reported that mosapride citrate acts on the α7nACh receptor and,&#xD;
      consequently, suppresses the inflammatory response of macrophages, thereby suppressing the&#xD;
      mechanism that induces paralysis after surgery.&#xD;
&#xD;
      To date, this study is intended to analyze whether mosapride citrate significantly affects&#xD;
      the improvement of bowel movement after surgery after gastrectomy.&quot;&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 27, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2021</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of radiopaque markers transferred to the large intestine 3 days after surgery</measure>
    <time_frame>3 Days after surgery</time_frame>
    <description>Intestinal motility after gastrectomy</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">104</enrollment>
  <condition>Stomach Cancer</condition>
  <arm_group>
    <arm_group_label>Mosapride group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive placebo or mosapride citrate (5mg/T) three times a day from the first day after surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients receive placebo instead of mosapride citrate (5mg/T) three times a day from the first day after surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mosapride citrate</intervention_name>
    <description>Patients receive mosapride citrate (5mg/T) three times a day from the first day after surgery.</description>
    <arm_group_label>Mosapride group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients diagnosed with gastric cancer pathologically before surgery&#xD;
&#xD;
          2. Patients who underwent surgical resection (R0 resection)&#xD;
&#xD;
          3. Patients with an ASA score of 3 or less&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients over 80 years old&#xD;
&#xD;
          2. When there are multiple or peritoneal metastases&#xD;
&#xD;
          3. Intestinal obstruction before surgery&#xD;
&#xD;
          4. When chemotherapy was performed before surgery&#xD;
&#xD;
          5. When cancer other than stomach cancer is diagnosed&#xD;
&#xD;
          6. If you have a long history of major intra-abdominal surgery or a history of abdominal&#xD;
             radiotherapy&#xD;
&#xD;
          7. In case of liver failure or kidney failure&#xD;
&#xD;
          8. When it is judged that uncontrolled diabetes may affect intestinal function&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gangnam Severance Hospital</investigator_affiliation>
    <investigator_full_name>In Gyu Kwon</investigator_full_name>
    <investigator_title>Assistnat Professor</investigator_title>
  </responsible_party>
  <keyword>Gastrectomy, Intestinal motility, Mosapride, Adhesion, Ileus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mosapride</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04493125
org study id: 3-2020-0175
nct id: NCT04493125
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
"Mosapride citrate is a 5-hydroxytryptamine 4 receptor agonist, and is widely used as an
      agent to increase intestinal motility. Mosapride citrate has been demonstrated in in vitro
      and in vivo studies to increase both gastric and colon motility. In a case-control study of
      patients undergoing colonectomy, mosapride citrate was found to significantly reduce gas
      passing and defecation time.

      Recently, a study reported that mosapride citrate acts on the α7nACh receptor and,
      consequently, suppresses the inflammatory response of macrophages, thereby suppressing the
      mechanism that induces paralysis after surgery.

      To date, this study is intended to analyze whether mosapride citrate significantly affects
      the improvement of bowel movement after surgery after gastrectomy."
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: The number of radiopaque markers transferred to the large intestine 3 days after surgery
time frame: 3 Days after surgery
description: Intestinal motility after gastrectomy
arm group label: Mosapride group
arm group type: Experimental
description: Patients receive placebo or mosapride citrate (5mg/T) three times a day from the first day after surgery.
arm group label: Placebo group
arm group type: Placebo Comparator
description: Patients receive placebo instead of mosapride citrate (5mg/T) three times a day from the first day after surgery
intervention type: Drug
intervention name: Mosapride citrate
description: Patients receive mosapride citrate (5mg/T) three times a day from the first day after surgery.
arm group label: Mosapride group
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Gangnam Severance Hospital
investigator full name: In Gyu Kwon
investigator title: Assistnat Professor
mesh term: Stomach Neoplasms
mesh term: Mosapride