<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/NCT03824548</url>
  </required_header>
  <id_info>
    <org_study_id>HLT-RWE-GERD-001</org_study_id>
    <nct_id>NCT03824548</nct_id>
  </id_info>
  <brief_title>Outcomes for Patients With Gastro-Esophageal Reflux Disease</brief_title>
  <official_title>Real-World Analysis on the Diagnosis, Treatment Pattern and Outcomes for Patients With Gastro-Esophageal Reflux Disease (GERD) in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Happy Life Technology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin Happy Life Technology Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Gastro-esophageal reflux disease (GERD), the most common cause of erosive esophagitis (EE),&#xD;
      remains highly prevalent worldwide.&#xD;
&#xD;
      GERD poses substantial burden on both patients and society. EE treatment patterns and unmet&#xD;
      needs have been well-studied overseas, but evidence gaps still exist in China.&#xD;
&#xD;
      To fill these evidence gaps, real-world evidence for GERD and EE are needed. To understand&#xD;
      GERD market we will analysis :Patient profile,GERD patient journey within hospital (first&#xD;
      present, get diagnosed, receive initial and maintenance treatment),medication cost,department&#xD;
      differentiation.&#xD;
&#xD;
      To investigate current treatment patterns of GERD / EE in China we will analysis: Current&#xD;
      agents used and treatment duration in clinical practice treatment patterns by different&#xD;
      reimbursement status treatment pattern by EE/NERD.&#xD;
&#xD;
      To get healing rate of EE we will analysis: Real-world efficacy of the current standard&#xD;
      treatment (i.e. PPIs) for patient with two test results of gastroscopy.&#xD;
&#xD;
      The data required for this project are accessible in hospital electronic system; no specific&#xD;
      data collection tools or methods are required for this project design. Only algorithms for&#xD;
      retrieving and extracting eligible patients' records are required and will be developed by&#xD;
      HLT based on the eligibility criteria defined in this protocol.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Anticipated">May 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of GERD patients with an EE diagnosis confirmed by physician judgment vs. endoscopy</measure>
    <time_frame>oOnly patients diagnosed between January 1st, 2015 and October 31st, 2017 will be included to allow for at least an 8-week observational period.</time_frame>
    <description>oAnalysis can be stratified by age group, sex, and health plan type to investigate possible differences in diagnostic practices based on these related patient characteristics.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Similarly, descriptive statistics will also be presented for secondary endpoints as the analysis further examines treatment use and proxy indicators assessing real-world treatment efficacy.</measure>
    <time_frame>Only patients diagnosed between January 1st, 2015 and October 31st, 2017 will be included to allow for at least an 8-week observational period.</time_frame>
    <description>Proportion of EE patients and NERD patients by treatment use</description>
  </secondary_outcome>
  <enrollment type="Anticipated">50000</enrollment>
  <condition>Gastro-esophageal Reflux Disease</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>this is non-intervention study, there is no intervention drug or device in this study.</intervention_name>
    <description>this is exactly a non-interventional study, no intervention during the whole study.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The overall analysis population will consist of patients of all ages who were diagnosed&#xD;
        with GERD from January 2015 to December 2017.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medical records of GERD, NERD and/or EE diagnoses （ICD code scope will be confirmed&#xD;
             later）from January 1st, 2015 to December 31st, 2017.&#xD;
&#xD;
        oGERD is typically characterized by symptoms of heartburn and acid regurgitation. A&#xD;
        diagnosis of EE or NERD can only be confirmed upon endoscopic examination.&#xD;
&#xD;
          -  All ages, males or females&#xD;
&#xD;
          -  A primary diagnosis of GERD/NERD/EE&#xD;
&#xD;
        For treatment patterns, patients are also required to have received one episode of&#xD;
        treatment during the analysis period.&#xD;
&#xD;
        For RW treatment efficacy, the population will be restricted to the EE treatment population&#xD;
        who underwent at least two endoscopy examinations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - No exclusion criteria will be applied for investigating diagnosis since all patients&#xD;
        diagnosed with GERD, NERD, or EE should be captured regardless of whether they have medical&#xD;
        conditions that affect their treatments.&#xD;
&#xD;
        A patient will not be eligible for investigating treatment patterns and RW treatment&#xD;
        efficacy if he/she has any of the following exclusion criterion:&#xD;
&#xD;
          -  A post-operative diagnosis of gastrointestinal cancers&#xD;
&#xD;
          -  A diagnosis of esophageal foreign bodies or neoplasms&#xD;
&#xD;
          -  A history of gastric or esophageal surgery&#xD;
&#xD;
          -  Zollinger-Ellison syndrome&#xD;
&#xD;
          -  Primary esophageal motility disorders (ex: achalasia)&#xD;
&#xD;
          -  Esophageal strictures&#xD;
&#xD;
          -  Eosinophilic esophagitis&#xD;
&#xD;
          -  Identified as pregnant or lactating&#xD;
&#xD;
          -  Hospitalized (inpatient) patients (to be confirmed by expert.) due to GERD as primary&#xD;
             or secondary diagnosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Yuan Na</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuan Na, master</last_name>
      <phone>13911152732</phone>
      <email>na.yuan@yiducloud.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 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>
    <mesh_term>Esophagitis, Peptic</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/NCT03824548
org study id: HLT-RWE-GERD-001
nct id: NCT03824548
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Gastro-esophageal reflux disease (GERD), the most common cause of erosive esophagitis (EE),
      remains highly prevalent worldwide.

      GERD poses substantial burden on both patients and society. EE treatment patterns and unmet
      needs have been well-studied overseas, but evidence gaps still exist in China.

      To fill these evidence gaps, real-world evidence for GERD and EE are needed. To understand
      GERD market we will analysis :Patient profile,GERD patient journey within hospital (first
      present, get diagnosed, receive initial and maintenance treatment),medication cost,department
      differentiation.

      To investigate current treatment patterns of GERD / EE in China we will analysis: Current
      agents used and treatment duration in clinical practice treatment patterns by different
      reimbursement status treatment pattern by EE/NERD.

      To get healing rate of EE we will analysis: Real-world efficacy of the current standard
      treatment (i.e. PPIs) for patient with two test results of gastroscopy.

      The data required for this project are accessible in hospital electronic system; no specific
      data collection tools or methods are required for this project design. Only algorithms for
      retrieving and extracting eligible patients' records are required and will be developed by
      HLT based on the eligibility criteria defined in this protocol.
observational model: Other
time perspective: Retrospective
measure: Proportion of GERD patients with an EE diagnosis confirmed by physician judgment vs. endoscopy
time frame: oOnly patients diagnosed between January 1st, 2015 and October 31st, 2017 will be included to allow for at least an 8-week observational period.
description: oAnalysis can be stratified by age group, sex, and health plan type to investigate possible differences in diagnostic practices based on these related patient characteristics.
measure: Similarly, descriptive statistics will also be presented for secondary endpoints as the analysis further examines treatment use and proxy indicators assessing real-world treatment efficacy.
time frame: Only patients diagnosed between January 1st, 2015 and October 31st, 2017 will be included to allow for at least an 8-week observational period.
description: Proportion of EE patients and NERD patients by treatment use
intervention type: Other
intervention name: this is non-intervention study, there is no intervention drug or device in this study.
description: this is exactly a non-interventional study, no intervention during the whole study.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Gastroesophageal Reflux
mesh term: Esophagitis, Peptic
sharing ipd: No