<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/NCT02243618</url>
  </required_header>
  <id_info>
    <org_study_id>4-2014-0381</org_study_id>
    <nct_id>NCT02243618</nct_id>
  </id_info>
  <brief_title>The Effect of Proton Pump Inhibitor and Polaprezinc Combination Therapy for Healing of Endoscopic Submucosal Dissection-induced Ulcer</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc&#xD;
      resection of superficial tumors in the gastrointestinal tract. ESD, however, is a&#xD;
      time-consuming procedure that requires a high level of endoscopic skill to achieve a&#xD;
      desirable oncologic outcome. Several procedure-related complications may occur after ESD.&#xD;
      Especially, iatrogenic ulcer bleeding after ESD can be a concern for both endoscopists and&#xD;
      patients. In order to reduce the bleeding rate, proton pump inhibitors (PPIs) are&#xD;
      administered after ESD. In addition, ulcer protective agents such as rebamipide can be added&#xD;
      to PPIs for accelerating ulcer healing. We aimed to evaluate the efficacy of polaprezinc for&#xD;
      healing of iatrogenic ulcer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2015</start_date>
  <completion_date type="Actual">April 14, 2016</completion_date>
  <primary_completion_date type="Actual">April 14, 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ulcering healing rate</measure>
    <time_frame>4 weeks after the ESD</time_frame>
    <description>Healing rate of the iatrogenic ulcer according to the type of ulcer protective agents (polaprezinc vs. rebamipide).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Scarring change rate</measure>
    <time_frame>4 weeks after the ESD</time_frame>
    <description>Scarring change rate of the iatrogenic ulcer according to the type of ulcer protective agents (polaprezinc vs. rebamipide).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">153</enrollment>
  <condition>Gastric Adenoma</condition>
  <condition>Early Gastric Cancer</condition>
  <arm_group>
    <arm_group_label>Rebamipide group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Polaprezinc group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Polaprezinc</intervention_name>
    <description>Administration of pantoprazole 40 mg q.d. and polaprezinc 75 mg b.i.d. for 4 weeks after the ESD.</description>
    <arm_group_label>Polaprezinc group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rebamipide</intervention_name>
    <description>Administration of pantoprazole 40 mg q.d. and rebamipide 100 mg t.i.d. for 4 weeks after the ESD.</description>
    <arm_group_label>Rebamipide group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age, between 19 and 79&#xD;
&#xD;
          2. Patients with gastric adenoma or early gastric cancer&#xD;
&#xD;
          3. Patients with ECOG-PS 0 or 1&#xD;
&#xD;
          4. Patients with adequate renal function&#xD;
&#xD;
          5. Patients with adequate hepatic function&#xD;
&#xD;
          6. Patients with adequate bone marrow function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who has taken the medications for ulcer including PPIs, H2 blockers, and&#xD;
             mucosal protective agents within 3 months prior to the ESD.&#xD;
&#xD;
          2. Patients who has taken steroid or NSAIDswithin 3 months prior to the ESD.&#xD;
&#xD;
          3. Patients who has undergone gastrostomy&#xD;
&#xD;
          4. Patients with allergy for pantoprazole, polaprezinc, or rebamipide.&#xD;
&#xD;
          5. Pregnant or breast feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sevrance hospital</name>
      <address>
        <city>Seoul</city>
        <zip>120-752</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2014</study_first_posted>
  <last_update_submitted>March 25, 2019</last_update_submitted>
  <last_update_submitted_qc>March 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rebamipide</mesh_term>
    <mesh_term>Polaprezinc</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/NCT02243618
org study id: 4-2014-0381
nct id: NCT02243618
lead sponsor: 
has dmc: No
Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc
      resection of superficial tumors in the gastrointestinal tract. ESD, however, is a
      time-consuming procedure that requires a high level of endoscopic skill to achieve a
      desirable oncologic outcome. Several procedure-related complications may occur after ESD.
      Especially, iatrogenic ulcer bleeding after ESD can be a concern for both endoscopists and
      patients. In order to reduce the bleeding rate, proton pump inhibitors (PPIs) are
      administered after ESD. In addition, ulcer protective agents such as rebamipide can be added
      to PPIs for accelerating ulcer healing. We aimed to evaluate the efficacy of polaprezinc for
      healing of iatrogenic ulcer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Ulcering healing rate
time frame: 4 weeks after the ESD
description: Healing rate of the iatrogenic ulcer according to the type of ulcer protective agents (polaprezinc vs. rebamipide).
measure: Scarring change rate
time frame: 4 weeks after the ESD
description: Scarring change rate of the iatrogenic ulcer according to the type of ulcer protective agents (polaprezinc vs. rebamipide).
arm group label: Rebamipide group
arm group type: Active Comparator
arm group label: Polaprezinc group
arm group type: Active Comparator
intervention type: Drug
intervention name: Polaprezinc
description: Administration of pantoprazole 40 mg q.d. and polaprezinc 75 mg b.i.d. for 4 weeks after the ESD.
arm group label: Polaprezinc group
intervention type: Drug
intervention name: Rebamipide
description: Administration of pantoprazole 40 mg q.d. and rebamipide 100 mg t.i.d. for 4 weeks after the ESD.
arm group label: Rebamipide group
criteria: 
gender: All
minimum age: 19 Years
maximum age: 79 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Adenoma
mesh term: Rebamipide
mesh term: Polaprezinc