<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/NCT03024086</url>
  </required_header>
  <id_info>
    <org_study_id>DW_DWJ1252002</org_study_id>
    <nct_id>NCT03024086</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia</brief_title>
  <official_title>Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study (PART 1)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daewoong Pharmaceutical Co. LTD.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Daewoong Pharmaceutical Co. LTD.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the Efficacy and Safety of DWJ1252 in treatment of&#xD;
      Functional Dyspepsia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2016</start_date>
  <completion_date type="Actual">April 25, 2017</completion_date>
  <primary_completion_date type="Actual">April 25, 2017</primary_completion_date>
  <phase>Phase 3</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 change from baseline in GIS (Gastrointestinal Symptom Score)</measure>
    <time_frame>At 4 Weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">124</enrollment>
  <condition>Functional Dyspepsia</condition>
  <arm_group>
    <arm_group_label>DWJ1252</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DWJ1252 + Placebo of Gasmotin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gasmotin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gasmotin + Placebo of DWJ1252</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DWJ1252</intervention_name>
    <description>DWJ1252 and Placebo of Gasmotin</description>
    <arm_group_label>DWJ1252</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gasmotin</intervention_name>
    <description>Gasmotin and Placebo of DWJ1252</description>
    <arm_group_label>Gasmotin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male of female of at least 19 years old&#xD;
&#xD;
          -  Patient with functional dyspepsia met the ROME III criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with previous gastrointestinal surgery&#xD;
&#xD;
          -  Patients with history of gastrointestinal bleeding, mechanical obstruction,&#xD;
             perforation&#xD;
&#xD;
          -  Patients with history of gastrointestinal cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hanyang University Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 29, 2016</study_first_submitted>
  <study_first_submitted_qc>January 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>June 25, 2019</last_update_submitted>
  <last_update_submitted_qc>June 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 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>Dyspepsia</mesh_term>
  </condition_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/NCT03024086
org study id: DW_DWJ1252002
nct id: NCT03024086
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the Efficacy and Safety of DWJ1252 in treatment of
      Functional Dyspepsia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: The change from baseline in GIS (Gastrointestinal Symptom Score)
time frame: At 4 Weeks
arm group label: DWJ1252
arm group type: Experimental
description: DWJ1252 + Placebo of Gasmotin
arm group label: Gasmotin
arm group type: Active Comparator
description: Gasmotin + Placebo of DWJ1252
intervention type: Drug
intervention name: DWJ1252
description: DWJ1252 and Placebo of Gasmotin
arm group label: DWJ1252
intervention type: Drug
intervention name: Gasmotin
description: Gasmotin and Placebo of DWJ1252
arm group label: Gasmotin
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Dyspepsia
sharing ipd: No