<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/NCT03811080</url>
  </required_header>
  <id_info>
    <org_study_id>DW_DWP14012302</org_study_id>
    <nct_id>NCT03811080</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non Erosive Reflux Disease</brief_title>
  <official_title>A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non-Erosive Gastroesophageal Reflux Disease</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to demonstrate the superiority of efficacy of DWP14012, once&#xD;
      daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multi-center, double blind, randomized, placebo-controlled, parallel-group, phase 3&#xD;
      study. Subjects will be randomly assigned to one of the three treatment groups (DWP14012 A mg&#xD;
      or DWP14012 B mg or placebo).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 7, 2019</start_date>
  <completion_date type="Anticipated">February 2020</completion_date>
  <primary_completion_date type="Anticipated">February 2020</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>1. Percentage of patients with complete resolution of major symptoms (heartburn and acid regurgitation) at 4-week</measure>
    <time_frame>4 week</time_frame>
    <description>defined as no episodes of symptom during the last 7 days of treatment, using Reflux Disease Questionnaire(RDQ)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)</measure>
    <time_frame>2 week, 4 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reflux disease symptom assessment using Subject diary</measure>
    <time_frame>4 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life assessment using PAGI-QoL</measure>
    <time_frame>4 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of rescue medication</measure>
    <time_frame>4 week</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">327</enrollment>
  <condition>Non-Erosive Gastroesophageal Reflux Disease</condition>
  <arm_group>
    <arm_group_label>DWP14012 A mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DWP14012 A mg, tablet, once daily, oral administration for up to 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DWP14012 B mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DWP14012 B mg, tablet, once daily, oral administration for up to 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, tablet, once daily, oral administration for up to 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DWP14012 A mg</intervention_name>
    <description>The participants will receive treatment of DWP14012 A mg, tablet, orally, once daily and DWP14012 B mg placebo-matching tablet, orally, once daily for up to 4 weeks.</description>
    <arm_group_label>DWP14012 A mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DWP14012 B mg</intervention_name>
    <description>The participants will receive treatment of DWP14012 B mg, tablet, orally, once daily and DWP14012 A mg placebo-matching tablet, orally, once daily for up to 4 weeks.</description>
    <arm_group_label>DWP14012 B mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>The participants will receive treatment of DWP14012 A mg placebo-matching tablet, orally, once daily and DWP14012 B mg placebo-matching tablet, orally, once daily for up to 4 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects aged between 20 and 75 years&#xD;
&#xD;
          2. Subjects who were not observed mucosal break according to the LA classification(LA&#xD;
             grade) on the EGD&#xD;
&#xD;
          3. Subjects who had experienced major symptom within 3 months&#xD;
&#xD;
          4. Subjects who had experienced major symptom within 7 days before randomization. Entry&#xD;
             into study also required that patients had experienced at least mild symptoms on at&#xD;
             least 2 days/week or at least moderate symptoms on at least 1 day/week&#xD;
&#xD;
          5. Subjects who is able to understand and follow the instructions&#xD;
&#xD;
          6. Subjects who voluntarily signed written informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who have Barrett's esophagus, gastroesophageal varices, esophageal stenosis,&#xD;
             ulcer stenosis, active gastric ulcer, gastrointestinal bleeding or malignant tumor&#xD;
             confirmed by endoscopy&#xD;
&#xD;
          2. Subjects who have erosive esophagitis, acute upper gastrointestinal bleeding, gastric&#xD;
             ulcers or duodenal ulcers within 2 months before Visit 1&#xD;
&#xD;
          3. Subjects diagnosed with functional dyspepsia, primary esophageal motility disorder,&#xD;
             IBS, IBD in the last 3 months&#xD;
&#xD;
          4. Subjects who have a history of gastric acid suppression surgery or gastroesophageal&#xD;
             surgery&#xD;
&#xD;
          5. Subjects with Zollinger-Ellison syndrome&#xD;
&#xD;
          6. Subjects with eosinophilic esophagitis&#xD;
&#xD;
          7. Subjects with clinically significant liver, kidney, nervous system, respiratory,&#xD;
             endocrine, hematologic, cardiovascular, urinary system disease .&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Daewoong Pharmaceutical Co. LTD.</last_name>
  </overall_contact>
  <location>
    <facility>
      <name>Hanyang University Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ohyoung Lee</last_name>
      <phone>82-2-2290-9652</phone>
      <email>irb@hyumc.com</email>
    </contact>
    <investigator>
      <last_name>Ohoyoung Lee</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>June 23, 2019</last_update_submitted>
  <last_update_submitted_qc>June 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 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>Gastroesophageal Reflux</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fexuprazan</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/NCT03811080
org study id: DW_DWP14012302
nct id: NCT03811080
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to demonstrate the superiority of efficacy of DWP14012, once
      daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4.
This is a multi-center, double blind, randomized, placebo-controlled, parallel-group, phase 3
      study. Subjects will be randomly assigned to one of the three treatment groups (DWP14012 A mg
      or DWP14012 B mg or placebo).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: 1. Percentage of patients with complete resolution of major symptoms (heartburn and acid regurgitation) at 4-week
time frame: 4 week
description: defined as no episodes of symptom during the last 7 days of treatment, using Reflux Disease Questionnaire(RDQ)
measure: Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)
time frame: 2 week, 4 week
measure: Reflux disease symptom assessment using Subject diary
time frame: 4 week
measure: Quality of Life assessment using PAGI-QoL
time frame: 4 week
measure: Use of rescue medication
time frame: 4 week
arm group label: DWP14012 A mg
arm group type: Experimental
description: DWP14012 A mg, tablet, once daily, oral administration for up to 4 weeks
arm group label: DWP14012 B mg
arm group type: Experimental
description: DWP14012 B mg, tablet, once daily, oral administration for up to 4 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo, tablet, once daily, oral administration for up to 4 weeks
intervention type: Drug
intervention name: DWP14012 A mg
description: The participants will receive treatment of DWP14012 A mg, tablet, orally, once daily and DWP14012 B mg placebo-matching tablet, orally, once daily for up to 4 weeks.
arm group label: DWP14012 A mg
intervention type: Drug
intervention name: DWP14012 B mg
description: The participants will receive treatment of DWP14012 B mg, tablet, orally, once daily and DWP14012 A mg placebo-matching tablet, orally, once daily for up to 4 weeks.
arm group label: DWP14012 B mg
intervention type: Drug
intervention name: Placebo
description: The participants will receive treatment of DWP14012 A mg placebo-matching tablet, orally, once daily and DWP14012 B mg placebo-matching tablet, orally, once daily for up to 4 weeks.
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Daewoong Pharmaceutical Co. LTD.
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Gastroesophageal Reflux
mesh term: Fexuprazan