<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/NCT01729182</url>
  </required_header>
  <id_info>
    <org_study_id>D961PC00002</org_study_id>
    <nct_id>NCT01729182</nct_id>
  </id_info>
  <brief_title>Nexium Capsules LDA Specific Clinical Experience Investigation</brief_title>
  <official_title>Nexium Capsules Specific Clinical Experience Investigation for Long-term Use Concerning Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer With LDA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <brief_summary>
    <textblock>
      The purpose of this investigation is to collect following data in patients given Nexium&#xD;
      capsule (Nexium) for long term in usual-post-marketing therapy to prevention of recurrence of&#xD;
      gastric ulcer or duodenal ulcer with Low dose Aspirin (LDA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nexium capsules Specific Clinical Experience Investigation for long-term use concerning&#xD;
      prevention of recurrence of gastric ulcer or duodenal ulcer with Low dose Aspirin (LDA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2013</start_date>
  <completion_date type="Actual">March 9, 2017</completion_date>
  <primary_completion_date type="Actual">March 9, 2017</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>Adverse events incidence</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Number of Adverse Drug Reactions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Non-recurrence rate of peptic ulcer</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2363</enrollment>
  <condition>Gastric Ulcer</condition>
  <condition>Duodenal Ulcer</condition>
  <arm_group>
    <arm_group_label>Nexium</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The patients who are continuously given Low dose Aspirin (LDA) to suppress&#xD;
        thrombus/embolism and who will be given Nexium for the first time to suppress recurrence of&#xD;
        gastric ulcer and duodenal ulcer.&#xD;
&#xD;
        (Patients who have previous experience of Nexium given in the treatment for gastric ulcer&#xD;
        or duodenal ulcer can be registered to this S-CEI.)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients having gastric ulcer/duodenal ulcer when Nexium is started (Active phase (A1,&#xD;
             A2) or healing phase (H1, H2) of Sakita-Miwa classification on endoscopy).&#xD;
&#xD;
          -  Patients who had been given Nexium for suppression of recurrence of gastric&#xD;
             ulcer/duodenal ulcer.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shigeru Yoshida, MD</last_name>
    <role>Study Director</role>
    <affiliation>AstraZeneca K.K.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aichi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Akita</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aomori</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chiba</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ehime</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fukui</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fukushima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gifu</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gunma</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hokkaido</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hyogo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ibaraki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ishikawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Iwate</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kagoshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kanagawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kochi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kumamoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Mie</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miyagi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Miyazaki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nagano</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nagasaki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nara</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Niigata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Oita</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Okayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Okinawa</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saga</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Saitama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shiga</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shimane</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Shizuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tochigi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tokushima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tottori</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toyama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wakayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yamagata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yamaguchi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Yamanashi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&amp;studyid=709&amp;filename=AZ%20Synopsis%20_D961PC00002.pdf</url>
    <description>AZ_Synopsis_D961PC00002</description>
  </link>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D961PC00002&amp;attachmentIdentifier=3369ebc0-0d02-4d61-998f-b9321c317c64&amp;fileName=NEX_SCEI_LDA_Protocol(E)_Ver3_redacted.pdf&amp;versionIdentifier=</url>
    <description>K. Sakamoto, M. Nii, T. Tokimoto and Y. Takumi Efficacy and Safety of Esomeprazole (Nexium) for the Prevention of Recurrent Gastric or Duodenal Ulcers in Patients on Continuous LDA; PMS of Long-term Use Jpn Pharmacol Ther, 47(6), 893 - 910, 2019</description>
  </link>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>August 5, 2019</last_update_submitted>
  <last_update_submitted_qc>August 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Low dose Aspirin(LDA)</keyword>
  <keyword>Gastric ulcer or duodenal ulcer</keyword>
  <keyword>Nexium</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Ulcer</mesh_term>
    <mesh_term>Duodenal Ulcer</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_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/NCT01729182
org study id: D961PC00002
nct id: NCT01729182
lead sponsor: 
The purpose of this investigation is to collect following data in patients given Nexium
      capsule (Nexium) for long term in usual-post-marketing therapy to prevention of recurrence of
      gastric ulcer or duodenal ulcer with Low dose Aspirin (LDA).
Nexium capsules Specific Clinical Experience Investigation for long-term use concerning
      prevention of recurrence of gastric ulcer or duodenal ulcer with Low dose Aspirin (LDA).
observational model: Cohort
time perspective: Prospective
measure: Adverse events incidence
time frame: Up to 2 years
description: Number of Adverse Drug Reactions
measure: Non-recurrence rate of peptic ulcer
time frame: Up to 2 years
arm group label: Nexium
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Shigeru Yoshida, MD
role: Study Director
affiliation: AstraZeneca K.K.
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country: Japan
url: http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=709&filename=AZ%20Synopsis%20_D961PC00002.pdf
description: AZ_Synopsis_D961PC00002
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D961PC00002&attachmentIdentifier=3369ebc0-0d02-4d61-998f-b9321c317c64&fileName=NEX_SCEI_LDA_Protocol(E)_Ver3_redacted.pdf&versionIdentifier=
description: K. Sakamoto, M. Nii, T. Tokimoto and Y. Takumi Efficacy and Safety of Esomeprazole (Nexium) for the Prevention of Recurrent Gastric or Duodenal Ulcers in Patients on Continuous LDA; PMS of Long-term Use Jpn Pharmacol Ther, 47(6), 893 - 910, 2019
responsible party type: Sponsor
mesh term: Stomach Ulcer
mesh term: Duodenal Ulcer
mesh term: Ulcer