<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/NCT04501627</url>
  </required_header>
  <id_info>
    <org_study_id>Vonoprazan-4007</org_study_id>
    <nct_id>NCT04501627</nct_id>
  </id_info>
  <brief_title>A Study on Vonoprazan in the Real-world Clinical Practice in China</brief_title>
  <acronym>VIEW</acronym>
  <official_title>A Multi-center, Single-arm, Prospective, Non-interventional Study on Vonoprazan in the Real-world Clinical Practice in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to evaluate the safety of Vonoprazan by assessing all adverse&#xD;
      events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs) in routine&#xD;
      clinical settings in China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, non-interventional study in Chinese participants with RE who are&#xD;
      receiving or will receive the standard treatment of vonoprazan. This study will assess the&#xD;
      safety and effectiveness of vonoprazan in the real-world clinical practice.&#xD;
&#xD;
      The study will enroll approximately 3000 participants. The data will be collected through&#xD;
      participants' medical records, self-reported questionnaires, and recorded information on&#xD;
      symptom via diaries. All the participants will be assigned to a single observational cohort:&#xD;
&#xD;
      • Participants with RE&#xD;
&#xD;
      The multi-center trial will be conducted in China. The standard treatment will be of 4 weeks&#xD;
      or it may reach up to 8 weeks if the dosing proves insufficient. All participants will be&#xD;
      followed up for additional 2 weeks after the standard treatment. The overall duration of the&#xD;
      study will be approximately 10 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 24, 2020</start_date>
  <completion_date type="Actual">October 24, 2022</completion_date>
  <primary_completion_date type="Actual">October 24, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Reporting one or More AEs</measure>
    <time_frame>Up to Week 10</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Reporting one or More SAEs</measure>
    <time_frame>Up to Week 10</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Reporting one or More ADRs</measure>
    <time_frame>Up to Week 10</time_frame>
    <description>ADRs refers to AE related to administered drug.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Endoscopic Healing of Reflux Esophagitis (RE) During 4-week Treatment</measure>
    <time_frame>Baseline up to Week 4</time_frame>
    <description>Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification Grade O during the treatment phase. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break less than [&lt;] 5 millimeter [mm]), Grade B (Mucosal break greater than or equal to [&gt;=] 5 mm), Grade C (Mucosal break continuous between two or more folds and &lt;75% of the esophageal circumference) and Grade D (Mucosal break &gt;=75 percent [%] of the esophageal circumference).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Endoscopic Healing of RE During 8-week Treatment</measure>
    <time_frame>Baseline up to Week 8</time_frame>
    <description>Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification Grade O during the treatment phase. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break &lt;5 mm), Grade B (Mucosal break &gt;=5 mm), Grade C (Mucosal break continuous between two or more folds and &lt;75% of the esophageal circumference) and Grade D (Mucosal break &gt;=75% of the esophageal circumference).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of RE Participants Without Gastroesophageal Reflux Disease (GERD) Typical Symptoms</measure>
    <time_frame>Baseline and Week 4</time_frame>
    <description>The severity of participants' GERD symptoms based on the investigator's assessment among all participants will be evaluated at Baseline and Week 4. GERD symptoms will be assessed on a 5-point scale, wherein 1= no symptom, 2= mild, 3= moderate, 4= severe and 5= very severe. GERD symptoms include heartburn (HB), acid regurgitation (AR), dysphagia (dysp), belching (bch) and epigastric pain (EP). The participants without any GERD typical symptoms will be analyzed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Heartburn at Baseline Achieving Complete Heartburn Symptom Relief During the First Week of Treatment</measure>
    <time_frame>Baseline up to Week 1</time_frame>
    <description>The complete relief of heartburn symptom is defined as no such symptom occurred on 7 consecutive days. Percentage of participants with complete relief during Week 1 will be reported. Reported data will be the percentage of participants, calculated by the (number of participants with complete heartburn symptom relief) divided by (the total number of participants) *100%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Night Time Heartburn at Baseline Achieving Complete Night Time Heartburn Symptom Relief During the First Week of Treatment</measure>
    <time_frame>Baseline up to Week 1</time_frame>
    <description>The complete relief of night time heartburn symptoms is defined as no such symptom occurred on 7 consecutive nights. Percentage of participants with complete relief during Week 1 will be reported. Reported data will be the percentage of participants, calculated by the (number of participants with complete night time heartburn symptom relief) divided by (the total number of participants) *100%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Acid Regurgitation at Baseline Achieving Complete Acid Regurgitation Symptom Relief During the First Week of Treatment</measure>
    <time_frame>Baseline up to Week 1</time_frame>
    <description>The complete relief of acid regurgitation symptom is defined as no symptoms of acid regurgitation occurring on 7 consecutive days. Percentage of participants with complete relief during Week 1 will be reported. Reported data will be the percentage of participants, calculated by the (number of participants with complete acid regurgitation symptom relief) divided by (the total number of participants) *100%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Night Time Acid Regurgitation Symptom at Baseline Achieving Complete Night Time Acid Regurgitation Symptom Relief During the First Week of Treatment</measure>
    <time_frame>Baseline up to Week 1</time_frame>
    <description>The complete relief of acid regurgitation symptoms durng night time is defined as no symptoms of acid regurgitation occurring on 7 consecutive nights. Percentage of participants with complete relief during Week 1 will be reported. Reported data will be the percentage of participants, calculated by the (number of participants with complete night time acid regurgitation symptom relief) divided by (the total number of participants) *100%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Gastroesophageal Reflux Disease Questionnaire (GerdQ) Score at Week 4</measure>
    <time_frame>Baseline up to Week 4</time_frame>
    <description>GerdQ is a self-completed participant questionnaire that is used to assess whether the following symptoms of RE are improved under treatment: heartburn, regurgitation, stomach pain, nausea, sleep disturbance and use of additional medication due to heartburn/regurgitation. Symptom frequency will be assessed for the week passed using following answers: 0 days, 1 day, 2-3 days, and 4-7 days. Each answer will be assigned a score from 0 to 3 (heartburn, regurgitation, sleep disturbance and use of additional medication due to heartburn/regurgitation) or from 3 to 0 (stomach pain, nausea). Total score will be calculated as a sum of 6 individual scores. GerdQ score was calculated as sum of these scores, giving a total score ranging from 0 to 18. When GerdQ &gt;=8, the participants could be symptom based diagnosed as GERD. Total score of 0 to 2 points= 0% likelihood of GERD; 3 to 7 points= 50% likelihood of GERD; 8 to 10 points= 79% likelihood of GERD; 11 to 18 points= 89% likelihood of GERD.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">3000</enrollment>
  <condition>Esophagitis Peptic</condition>
  <arm_group>
    <arm_group_label>Participants with RE</arm_group_label>
    <description>Participants diagnosed with RE who have received 20 milligram (mg) of vonoprazan in routine clinical practice, will be observed prospectively. Data will be collected from participants' medical records, self-reported questionnaires and recorded information on symptom via diaries.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Chinese participants who are prescribed with vonoprazan treatment in real-world clinical&#xD;
        practice will be observed prospectively.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Must be undergoing treatment with Vonoprazan.&#xD;
&#xD;
          2. Must be at least 18 years old.&#xD;
&#xD;
          3. Provide signed informed consent indicating that they (or a legally acceptable&#xD;
             representative) have been informed of all pertinent aspects of the study and are&#xD;
             willing to participate.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Are currently enrolled in or plan to participate in any other clinical trials (that is&#xD;
             interventional study).&#xD;
&#xD;
          2. Are contraindicated for Vonoprazan according to Product Package Insert.&#xD;
&#xD;
          3. With a known hepatic function impairment, including jaundice.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>000000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Tsinghua Changgung Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>102218</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yongchuan Hospital of Chongqing Medical University</name>
      <address>
        <city>Yongchuan</city>
        <state>Chongqing</state>
        <zip>402160</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lanzhou University Second Hospital</name>
      <address>
        <city>Lanzhou</city>
        <state>Gansu</state>
        <zip>730030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510260</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanfang Hospital of Southern Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510515</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third Affiliated Hospital, Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510630</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huazhong University of Science and Technology Union Shenzhen Hospital</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>518052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhuhai People's Hospital</name>
      <address>
        <city>Zhuhai</city>
        <state>Guangdong</state>
        <zip>519050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heilongjiang Provincial Hospital (Nanshang)</name>
      <address>
        <city>Harbin</city>
        <state>Heilongjiang</state>
        <zip>150036</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henan Provincial Peoples Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Union Hospital, Tongji Medical College of Huazhong University of Science &amp; Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital, Tongji Medical College, Huazhong University of Science &amp; Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changshu No.2 People's Hospital</name>
      <address>
        <city>Changshu</city>
        <state>Jiangsu</state>
        <zip>215500</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Drum Tower Hospital of Nanjing University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanjing First Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangxi Provincial People's Hospital</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qilu Hospital of Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shandong Provincial Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Qilu Hospital of Shandong University (Qingdao)</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <zip>266035</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weifang Peoples Hospital</name>
      <address>
        <city>Weifang</city>
        <state>Shandong</state>
        <zip>261041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yantai Affiliated Hospital of Binzhou Medical College</name>
      <address>
        <city>Yantai</city>
        <state>Shandong</state>
        <zip>264100</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chengdu Third People's Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610031</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>General Hospital of Tianjin</name>
      <address>
        <city>Tianjing</city>
        <state>Tianjin</state>
        <zip>300052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Hangzhou Normal University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhejiang Provincial People's Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Medical School of Ningbo University</name>
      <address>
        <city>Ningbo</city>
        <state>Zhejiang</state>
        <zip>315105</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wenzhou Central Hospital</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Wenzhou Medical College</name>
      <address>
        <city>Wenzhou</city>
        <state>Zhejiang</state>
        <zip>325027</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Fourth Affiliated Hospital Zhejiang University School of Medicine</name>
      <address>
        <city>Yiwu</city>
        <state>Zhejiang</state>
        <zip>32200</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.takeda.com/study-detail/5f9293e2296beb001e63bf63?idFilter=%5B%22Vonoprazan-4007%22%5D</url>
    <description>To obtain more information about this study, click this link.</description>
  </link>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophagitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/takeda/</ipd_url>
  </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/NCT04501627
org study id: Vonoprazan-4007
nct id: NCT04501627
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the safety of Vonoprazan by assessing all adverse
      events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs) in routine
      clinical settings in China.
This is a prospective, non-interventional study in Chinese participants with RE who are
      receiving or will receive the standard treatment of vonoprazan. This study will assess the
      safety and effectiveness of vonoprazan in the real-world clinical practice.

      The study will enroll approximately 3000 participants. The data will be collected through
      participants' medical records, self-reported questionnaires, and recorded information on
      symptom via diaries. All the participants will be assigned to a single observational cohort:

      • Participants with RE

      The multi-center trial will be conducted in China. The standard treatment will be of 4 weeks
      or it may reach up to 8 weeks if the dosing proves insufficient. All participants will be
      followed up for additional 2 weeks after the standard treatment. The overall duration of the
      study will be approximately 10 weeks.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants Reporting one or More AEs
time frame: Up to Week 10
measure: Percentage of Participants Reporting one or More SAEs
time frame: Up to Week 10
measure: Percentage of Participants Reporting one or More ADRs
time frame: Up to Week 10
description: ADRs refers to AE related to administered drug.
measure: Percentage of Participants with Endoscopic Healing of Reflux Esophagitis (RE) During 4-week Treatment
time frame: Baseline up to Week 4
description: Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification Grade O during the treatment phase. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break less than [<] 5 millimeter [mm]), Grade B (Mucosal break greater than or equal to [>=] 5 mm), Grade C (Mucosal break continuous between two or more folds and <75% of the esophageal circumference) and Grade D (Mucosal break >=75 percent [%] of the esophageal circumference).
measure: Percentage of Participants with Endoscopic Healing of RE During 8-week Treatment
time frame: Baseline up to Week 8
description: Endoscopic healing is defined as participants endoscopically diagnosed as Los Angeles classification Grade O during the treatment phase. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break <5 mm), Grade B (Mucosal break >=5 mm), Grade C (Mucosal break continuous between two or more folds and <75% of the esophageal circumference) and Grade D (Mucosal break >=75% of the esophageal circumference).
measure: Percentage of RE Participants Without Gastroesophageal Reflux Disease (GERD) Typical Symptoms
time frame: Baseline and Week 4
description: The severity of participants' GERD symptoms based on the investigator's assessment among all participants will be evaluated at Baseline and Week 4. GERD symptoms will be assessed on a 5-point scale, wherein 1= no symptom, 2= mild, 3= moderate, 4= severe and 5= very severe. GERD symptoms include heartburn (HB), acid regurgitation (AR), dysphagia (dysp), belching (bch) and epigastric pain (EP). The participants without any GERD typical symptoms will be analyzed.
measure: Percentage of Participants With Heartburn at Baseline Achieving Complete Heartburn Symptom Relief During the First Week of Treatment
time frame: Baseline up to Week 1
description: The complete relief of heartburn symptom is defined as no such symptom occurred on 7 consecutive days. Percentage of participants with complete relief during Week 1 will be reported. Reported data will be the percentage of participants, calculated by the (number of participants with complete heartburn symptom relief) divided by (the total number of participants) *100%.
measure: Percentage of Participants with Night Time Heartburn at Baseline Achieving Complete Night Time Heartburn Symptom Relief During the First Week of Treatment
time frame: Baseline up to Week 1
description: The complete relief of night time heartburn symptoms is defined as no such symptom occurred on 7 consecutive nights. Percentage of participants with complete relief during Week 1 will be reported. Reported data will be the percentage of participants, calculated by the (number of participants with complete night time heartburn symptom relief) divided by (the total number of participants) *100%.
measure: Percentage of Participants With Acid Regurgitation at Baseline Achieving Complete Acid Regurgitation Symptom Relief During the First Week of Treatment
time frame: Baseline up to Week 1
description: The complete relief of acid regurgitation symptom is defined as no symptoms of acid regurgitation occurring on 7 consecutive days. Percentage of participants with complete relief during Week 1 will be reported. Reported data will be the percentage of participants, calculated by the (number of participants with complete acid regurgitation symptom relief) divided by (the total number of participants) *100%.
measure: Percentage of Participants With Night Time Acid Regurgitation Symptom at Baseline Achieving Complete Night Time Acid Regurgitation Symptom Relief During the First Week of Treatment
time frame: Baseline up to Week 1
description: The complete relief of acid regurgitation symptoms durng night time is defined as no symptoms of acid regurgitation occurring on 7 consecutive nights. Percentage of participants with complete relief during Week 1 will be reported. Reported data will be the percentage of participants, calculated by the (number of participants with complete night time acid regurgitation symptom relief) divided by (the total number of participants) *100%.
measure: Change from Baseline in Gastroesophageal Reflux Disease Questionnaire (GerdQ) Score at Week 4
time frame: Baseline up to Week 4
description: GerdQ is a self-completed participant questionnaire that is used to assess whether the following symptoms of RE are improved under treatment: heartburn, regurgitation, stomach pain, nausea, sleep disturbance and use of additional medication due to heartburn/regurgitation. Symptom frequency will be assessed for the week passed using following answers: 0 days, 1 day, 2-3 days, and 4-7 days. Each answer will be assigned a score from 0 to 3 (heartburn, regurgitation, sleep disturbance and use of additional medication due to heartburn/regurgitation) or from 3 to 0 (stomach pain, nausea). Total score will be calculated as a sum of 6 individual scores. GerdQ score was calculated as sum of these scores, giving a total score ranging from 0 to 18. When GerdQ >=8, the participants could be symptom based diagnosed as GERD. Total score of 0 to 2 points= 0% likelihood of GERD; 3 to 7 points= 50% likelihood of GERD; 8 to 10 points= 79% likelihood of GERD; 11 to 18 points= 89% likelihood of GERD.
arm group label: Participants with RE
description: Participants diagnosed with RE who have received 20 milligram (mg) of vonoprazan in routine clinical practice, will be observed prospectively. Data will be collected from participants' medical records, self-reported questionnaires and recorded information on symptom via diaries.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Medical Director
role: Study Director
affiliation: Takeda
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country: China
url: https://clinicaltrials.takeda.com/study-detail/5f9293e2296beb001e63bf63?idFilter=%5B%22Vonoprazan-4007%22%5D
description: To obtain more information about this study, click this link.
responsible party type: Sponsor
mesh term: Esophagitis
sharing ipd: Yes
ipd description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
ipd url: https://vivli.org/ourmember/takeda/