xml: <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/NCT05966246</url>
    </required_header>
    <id_info>
      <org_study_id>3-2021-0480</org_study_id>
      <nct_id>NCT05966246</nct_id>
    </id_info>
    <brief_title>The Effect of Prucalopride Succinate on Gastrointestinal Motility After Laparoscopic Gastrectomy : Prospective Double Blind Case-control Study</brief_title>
    <official_title>The Effect of Prucalopride Succinate on Gastrointestinal Motility After Laparoscopic Gastrectomy : Prospective Double Blind Case-control Study</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>
        In order to improve postoperative ileus in patients undergoing gastrointestinal surgery,&#xD;
        digestive medications and prokinetics have been routinely used. Among them, mosapride citrate&#xD;
        is widely used as a representative drug, as it is a 5-hydroxytryptamine 4 receptor agonist&#xD;
        that increases gastrointestinal motility.&#xD;
  &#xD;
        Prucalopride succinate (dihydrobenzofurancarboxamide) is a type of 5-hydroxytryptamine 4&#xD;
        receptor agonist that has a higher affinity for the 5-HT4 receptor compared to mosapride (a&#xD;
        benzamide derivative) which belongs to the same class of drugs. Prucalopride succinate has&#xD;
        been demonstrated to increase both gastric and colonic motility through in vivo and in vitro&#xD;
        studies. As mentioned earlier, it exhibits high specificity for the 5-HT4 receptor. The 5-HT4&#xD;
        receptor is not expressed in the gastric mucosa but is expressed at low concentrations in the&#xD;
        small intestine, whereas it is highly expressed in the colonic mucosa. Therefore,&#xD;
        prucalopride is widely used as a therapeutic agent for chronic constipation by increasing&#xD;
        colonic motility. Furthermore, Prucalopride succinate stimulates the 5-HT4 receptors present&#xD;
        in the nerve terminals of the myenteric plexus, promoting the release of acetylcholine. The&#xD;
        released acetylcholine acts on α7nAch receptors located on the surface of enteric smooth&#xD;
        muscle cells, inhibiting inflammatory responses and reducing postoperative ilues.&#xD;
  &#xD;
        A randomized controlled trial (RCT) conducted on 110 patients who underwent gastrointestinal&#xD;
        surgery demonstrated that prucalopride succinate showed significant improvement in&#xD;
        gastrointestinal motility compared to the control group. Currently, mosapride citrate is&#xD;
        widely used as a prokinetic agent in clinical practice. However, preliminary studies have&#xD;
        shown no significant efficacy, and when comparing abdominal X-ray images taken on the third&#xD;
        day after surgery, there is no significant difference compared to the placebo group. As a&#xD;
        result, it can be observed that the recovery of gastrointestinal motility after surgery is&#xD;
        not primarily due to small bowel motility but rather delayed gas passing caused by colon&#xD;
        motility. Therefore, it can be assumed that using drugs that increase colon motility may be&#xD;
        effective in improving gastrointestinal motility after surgery.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 25, 2022</start_date>
    <completion_date type="Actual">June 30, 2023</completion_date>
    <primary_completion_date type="Actual">June 30, 2023</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>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Quantitative intestinal motility measurement using radio-opaque markers</measure>
      <time_frame>Every day from the 1st day to the 5th day after surgery</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Measurement of the amount of food intake, first flatus time and first defecation time</measure>
      <time_frame>Every day from the 1st day to the 5th day after surgery</time_frame>
      <description>Quantitatively compare and analyze the amount of food eaten in the test group and the control group.&#xD;
  Compare the first flatus appearance time and first defecation time in the test group and the control group.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">106</enrollment>
    <condition>Gastric Cancer</condition>
    <arm_group>
      <arm_group_label>Prucalopride succinate group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Taking prucalopride succinate from the first day to the fifth day after surgery.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control (mosapride citrate) group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Taking mosapride citrate from the first day to the fifth day after surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Arm I : Experimental (Prucalopride succinate group)</intervention_name>
      <description>Experimental group taking prucalopride succinate from day 1 to day 5 after surgery</description>
      <arm_group_label>Prucalopride succinate group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Arm II : Control (Mosapride citrate group)</intervention_name>
      <description>Control gourp taking mosapride citrate from day 1 day 5 after surgery</description>
      <arm_group_label>Control (mosapride citrate) group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients diagnosed with gastric adenocarcinoma pathologically before surgery&#xD;
  &#xD;
            2. Patients who underwent complete 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 of age&#xD;
  &#xD;
            2. Ascites or peritoneal metastasis&#xD;
  &#xD;
            3. If you have intestinal obstruction before surgery&#xD;
  &#xD;
            4. If chemotherapy was performed before surgery&#xD;
  &#xD;
            5. If cancer other than gastric cancer is diagnosed&#xD;
  &#xD;
            6. If there is a history of previous major intra-abdominal long-term surgery or abdominal&#xD;
               radiation therapy&#xD;
  &#xD;
            7. In case of liver failure or renal failure&#xD;
  &#xD;
            8. Pregnant women&#xD;
  &#xD;
            9. If it is judged that uncontrolled diabetes can affect intestinal function&#xD;
  &#xD;
           10. If you have a stoma&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>GangnamSeverance Hospital</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</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>Associate professor</investigator_title>
    </responsible_party>
    <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>Prucalopride</mesh_term>
      <mesh_term>Mosapride</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05966246
  org study id: 3-2021-0480
  nct id: NCT05966246
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In order to improve postoperative ileus in patients undergoing gastrointestinal surgery,
        digestive medications and prokinetics have been routinely used. Among them, mosapride citrate
        is widely used as a representative drug, as it is a 5-hydroxytryptamine 4 receptor agonist
        that increases gastrointestinal motility.
  
        Prucalopride succinate (dihydrobenzofurancarboxamide) is a type of 5-hydroxytryptamine 4
        receptor agonist that has a higher affinity for the 5-HT4 receptor compared to mosapride (a
        benzamide derivative) which belongs to the same class of drugs. Prucalopride succinate has
        been demonstrated to increase both gastric and colonic motility through in vivo and in vitro
        studies. As mentioned earlier, it exhibits high specificity for the 5-HT4 receptor. The 5-HT4
        receptor is not expressed in the gastric mucosa but is expressed at low concentrations in the
        small intestine, whereas it is highly expressed in the colonic mucosa. Therefore,
        prucalopride is widely used as a therapeutic agent for chronic constipation by increasing
        colonic motility. Furthermore, Prucalopride succinate stimulates the 5-HT4 receptors present
        in the nerve terminals of the myenteric plexus, promoting the release of acetylcholine. The
        released acetylcholine acts on α7nAch receptors located on the surface of enteric smooth
        muscle cells, inhibiting inflammatory responses and reducing postoperative ilues.
  
        A randomized controlled trial (RCT) conducted on 110 patients who underwent gastrointestinal
        surgery demonstrated that prucalopride succinate showed significant improvement in
        gastrointestinal motility compared to the control group. Currently, mosapride citrate is
        widely used as a prokinetic agent in clinical practice. However, preliminary studies have
        shown no significant efficacy, and when comparing abdominal X-ray images taken on the third
        day after surgery, there is no significant difference compared to the placebo group. As a
        result, it can be observed that the recovery of gastrointestinal motility after surgery is
        not primarily due to small bowel motility but rather delayed gas passing caused by colon
        motility. Therefore, it can be assumed that using drugs that increase colon motility may be
        effective in improving gastrointestinal motility after surgery.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Quantitative intestinal motility measurement using radio-opaque markers
  time frame: Every day from the 1st day to the 5th day after surgery
  measure: Measurement of the amount of food intake, first flatus time and first defecation time
  time frame: Every day from the 1st day to the 5th day after surgery
  description: Quantitatively compare and analyze the amount of food eaten in the test group and the control group.
  Compare the first flatus appearance time and first defecation time in the test group and the control group.
  arm group label: Prucalopride succinate group
  arm group type: Experimental
  description: Taking prucalopride succinate from the first day to the fifth day after surgery.
  arm group label: Control (mosapride citrate) group
  arm group type: Placebo Comparator
  description: Taking mosapride citrate from the first day to the fifth day after surgery.
  intervention type: Drug
  intervention name: Arm I : Experimental (Prucalopride succinate group)
  description: Experimental group taking prucalopride succinate from day 1 to day 5 after surgery
  arm group label: Prucalopride succinate group
  intervention type: Drug
  intervention name: Arm II : Control (Mosapride citrate group)
  description: Control gourp taking mosapride citrate from day 1 day 5 after surgery
  arm group label: Control (mosapride citrate) group
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 80 Years
  healthy volunteers: No
  facility: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Gangnam Severance Hospital
  investigator full name: In Gyu Kwon
  investigator title: Associate professor
  mesh term: Stomach Neoplasms
  mesh term: Prucalopride
  mesh term: Mosapride