<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/NCT03006874</url>
  </required_header>
  <id_info>
    <org_study_id>CJ_APA_304</org_study_id>
    <nct_id>NCT03006874</nct_id>
  </id_info>
  <brief_title>Study to Confirm the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis</brief_title>
  <official_title>A Double Blind, Randomized, Active-controlled, Phase 3 Study to Confirm the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HK inno.N Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HK inno.N Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to confirm the efficacy of CJ-12420, Once daily (QD), compared&#xD;
      to esomeprazole in patients with erosive esophagitis classified as Los Angeles (LA)&#xD;
      classification grades A to D at Week 8.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double blind, randomized, active controlled, phase 3 study. Subjects will be&#xD;
      randomly assigned to one of the three treatment groups (CJ-12420 50mg, CJ-12420 100mg,&#xD;
      esomeprazole 40mg).&#xD;
&#xD;
      All subjects will be asked to take three tablets at the same time each day throughout the&#xD;
      study, and also all subjects will be asked to record daytime and nighttime symptom in a&#xD;
      subject diary on a daily basis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2, 2016</start_date>
  <completion_date type="Actual">March 24, 2017</completion_date>
  <primary_completion_date type="Actual">March 24, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cumulative healing rate of erosive esophagitis at 8-week</measure>
    <time_frame>8 week</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Healing rate of erosive esophagitis at 4-week</measure>
    <time_frame>4-week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom assessment by subject diary</measure>
    <time_frame>4-week or 8-week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom assessment by questionnaire</measure>
    <time_frame>4-week or 8-week</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">302</enrollment>
  <condition>Erosive Esophagitis</condition>
  <arm_group>
    <arm_group_label>CJ-12420 50mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CJ-12420 50mg tablet, once daily, oral administration for up to 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CJ-12420 100mg QD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CJ-12420 100mg tablet, once daily, oral administration for up to 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Esomeprazole 40mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Esomeprazole 40mg, tablet. once daily, oral administration for up to 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CJ-12420 100mg QD</intervention_name>
    <description>CJ-12420 100mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of CJ-12420 100mg.</description>
    <arm_group_label>CJ-12420 100mg QD</arm_group_label>
    <other_name>Tegoprazan Tab.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Esomeprazole 40mg</intervention_name>
    <description>Esomeprazole 40mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of Esomeprazole 40mg.</description>
    <arm_group_label>Esomeprazole 40mg</arm_group_label>
    <other_name>Nexium Tab.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CJ-12420 50mg QD</intervention_name>
    <description>CJ-12420 50mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of CJ-12420 50mg.</description>
    <arm_group_label>CJ-12420 50mg QD</arm_group_label>
    <other_name>Tegoprazan Tab.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects aged between 20 and 75 years&#xD;
&#xD;
          2. Endoscopically confirmed erosive esophagitis as defined by LA Classification Grading&#xD;
             System (A-D) within 14 days prior to randomization&#xD;
&#xD;
          3. Subjects who had experienced heartburn and regurgitation within 7 days before visit 1&#xD;
&#xD;
          4. Subjects who is able to understand and follow the instructions and is willing to&#xD;
             participate throughout the entire study&#xD;
&#xD;
          5. Subjects who voluntarily signed written informed consent form&#xD;
&#xD;
          6. Subjects who agreed to use medically acceptable contraceptives during the period of&#xD;
             study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who cannot undergo EGD&#xD;
&#xD;
          2. Subjects who have esophageal stenosis, ulcer stenosis, gastroesophageal varices,&#xD;
             Barrett's esophagus, active gastric ulcer, gastrointestinal bleeding or malignant&#xD;
             tumor confirmed by EGD&#xD;
&#xD;
          3. Subjects who have warning symptoms of malignant gastrointestinal tract such as&#xD;
             odynophagia, severe dysphagia, bleeding, weight loss, anemia, or bloody stool&#xD;
&#xD;
          4. Subjects with eosinophilic esophagitis&#xD;
&#xD;
          5. Subjects diagnosed with primary esophageal motility disorder, IBS, IBD, etc. or with&#xD;
             suspected IBS in the last 3 months&#xD;
&#xD;
          6. Subjects who have a history of gastric acid suppression surgery or upper&#xD;
             gastrointestinal, esophageal surgery&#xD;
&#xD;
          7. Subjects who have AIDS or Hepatitis&#xD;
&#xD;
          8. Subjects who take antipsychotic drugs, antidepressant drug, antianxiety drug&#xD;
&#xD;
          9. Subjects who take gastric acid suppression like PPI within 2 weeks to EGD&#xD;
&#xD;
         10. Subjects who take medications related to reflux esophagitis more than 2 times within 1&#xD;
             weeks to EGD&#xD;
&#xD;
         11. Requirement of persistent daily use of drugs that may cause an ulcer such as&#xD;
             nonsteroidal anti-inflammatory drugs(NSAIDs) or aspirin during the course of the study&#xD;
&#xD;
         12. Pregnant or lactating women&#xD;
&#xD;
         13. Subjects with the following clinically significant laboratory abnormalities&#xD;
&#xD;
         14. Subjects with the following clinically significant ECG abnormalities&#xD;
&#xD;
         15. Sollinger-Ellison syndrome patients&#xD;
&#xD;
         16. Subjects with a history of malignant tumor&#xD;
&#xD;
         17. Subjects with a history of clinically significant hepatic, renal, cardiovascular,&#xD;
             respiratory, endocrine and CNS system disorder&#xD;
&#xD;
         18. Subjects with a history of hypersensitivity to the active ingredient or excipients of&#xD;
             the study drug, etc&#xD;
&#xD;
         19. Scheduled surgery requiring hospitalization or requirement of surgical treatment&#xD;
             during study participation&#xD;
&#xD;
         20. Subjects who participated in the other clinical trial within 4 weeks prior to&#xD;
             randomization&#xD;
&#xD;
         21. Subjects who are judged unsuitable to participate in the study in the opinion of the&#xD;
             investigator&#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_official>
    <last_name>Poong Ryul Lee, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>June 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</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>Esophagitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esomeprazole</mesh_term>
  </intervention_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/NCT03006874
org study id: CJ_APA_304
nct id: NCT03006874
lead sponsor: 
has dmc: No
The purpose of this study is to confirm the efficacy of CJ-12420, Once daily (QD), compared
      to esomeprazole in patients with erosive esophagitis classified as Los Angeles (LA)
      classification grades A to D at Week 8.
This is a double blind, randomized, active controlled, phase 3 study. Subjects will be
      randomly assigned to one of the three treatment groups (CJ-12420 50mg, CJ-12420 100mg,
      esomeprazole 40mg).

      All subjects will be asked to take three tablets at the same time each day throughout the
      study, and also all subjects will be asked to record daytime and nighttime symptom in a
      subject diary on a daily basis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Cumulative healing rate of erosive esophagitis at 8-week
time frame: 8 week
measure: Healing rate of erosive esophagitis at 4-week
time frame: 4-week
measure: Symptom assessment by subject diary
time frame: 4-week or 8-week
measure: Symptom assessment by questionnaire
time frame: 4-week or 8-week
arm group label: CJ-12420 50mg QD
arm group type: Experimental
description: CJ-12420 50mg tablet, once daily, oral administration for up to 8 weeks.
arm group label: CJ-12420 100mg QD
arm group type: Experimental
description: CJ-12420 100mg tablet, once daily, oral administration for up to 8 weeks.
arm group label: Esomeprazole 40mg
arm group type: Active Comparator
description: Esomeprazole 40mg, tablet. once daily, oral administration for up to 8 weeks.
intervention type: Drug
intervention name: CJ-12420 100mg QD
description: CJ-12420 100mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of CJ-12420 100mg.
arm group label: CJ-12420 100mg QD
other name: Tegoprazan Tab.
intervention type: Drug
intervention name: Esomeprazole 40mg
description: Esomeprazole 40mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of Esomeprazole 40mg.
arm group label: Esomeprazole 40mg
other name: Nexium Tab.
intervention type: Drug
intervention name: CJ-12420 50mg QD
description: CJ-12420 50mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of CJ-12420 50mg.
arm group label: CJ-12420 50mg QD
other name: Tegoprazan Tab.
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
last name: Poong Ryul Lee, Ph.D
role: Principal Investigator
affiliation: Samsung Medical Center
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Esophagitis
mesh term: Esomeprazole
sharing ipd: No