<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/NCT03284177</url>
  </required_header>
  <id_info>
    <org_study_id>334-103-00001</org_study_id>
    <secondary_id>JapicCTI-173713</secondary_id>
    <nct_id>NCT03284177</nct_id>
  </id_info>
  <brief_title>A Trial of C13-CAC Breath Test in PPI Resistant GERD Patients</brief_title>
  <official_title>A Multicenter, Open-label Trial to Investigate the Safety of C13-CAC and the Relationship Among C13-CAC Breath Test, Gastric pH, and the Improvement of Symptoms in PPI Resistant GERD Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Otsuka Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Otsuka 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>
      To investigate the safety of C13-CAC and the relationship among C13-CAC breath test, gastric&#xD;
      pH, and the improvement of symptoms by switching PPI in PPI resistant GERD patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 31, 2017</start_date>
  <completion_date type="Actual">December 4, 2018</completion_date>
  <primary_completion_date type="Actual">December 4, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>13CO2 concentration in expired air.</measure>
    <time_frame>5，10，15，20，25 and 30 minutes after C13-CAC administration.</time_frame>
    <description>Sensitivity and specificity of 13CO2 concentration in expired air for improvement of symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gastric pH</measure>
    <time_frame>1 hour prior to C13-CAC administration</time_frame>
    <description>Sensitivity and specificity of mean gastric pH for improvement of symptoms.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Gastroesophageal Reflux Disease</condition>
  <arm_group>
    <arm_group_label>C13-CAC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcium (13C)Carbonate</intervention_name>
    <description>C13-CAC breath test containing Calcium (13C) Carbonate was performed twice under fasting conditions.</description>
    <arm_group_label>C13-CAC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gastric acid inhibitors</intervention_name>
    <description>Gastric acid inhibitor was orally administrated once daily for 4weeks after first C13-CAC breath test.</description>
    <arm_group_label>C13-CAC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Gastric pH monitoring</intervention_name>
    <description>Gastric pH monitoring was performed once under fasting condition.</description>
    <arm_group_label>C13-CAC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  GERD patients who have been judged to require additional treatment to improve their&#xD;
             symptoms by investigator or subinvestigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients suspected to have hypothyroidism or hyperparathyroidism.&#xD;
&#xD;
          -  Patients with hypercalcemia&#xD;
&#xD;
          -  Patients with a history of gastric or duodenal surgery.&#xD;
&#xD;
          -  Patients who have received the eradication therapy of Helicobacter pylori within six&#xD;
             months prior to participation of the study.&#xD;
&#xD;
          -  Patients with a prior or current history of Zollinger-Ellison syndrome.&#xD;
&#xD;
          -  Patients with a history of surgery or treatment affecting gastroesophageal reflux.&#xD;
&#xD;
          -  Patients who have been diagnosed with acute upper gastrointestinal bleeding or active&#xD;
             gastric or duodenal ulcer within 30 days prior to participation of the study.&#xD;
&#xD;
          -  Patients with serious central nervous system disorders, cardiovascular disease,&#xD;
             pulmonary disease, hepatic disease, renal disease, metabolic disease, gastrointestinal&#xD;
             disorders, urinary disorders, endocrine disease, or blood dyspraxia.&#xD;
&#xD;
          -  Patients scheduled for surgery requiring hospitalization or required surgery during&#xD;
             the study period.&#xD;
&#xD;
          -  Patients who have had either a prior or current history of chest pain due to heart&#xD;
             disease or with chest pain suspected to have caused by heart disease within one year&#xD;
             prior to participation of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Akita University Hospital</name>
      <address>
        <city>Akita</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Hakodate Hospital</name>
      <address>
        <city>Hakodate</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shimane University Hospital</name>
      <address>
        <city>Izumo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kawasaki Medical School General Medical Center</name>
      <address>
        <city>Kurashiki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kawasaki Medical School Hospital</name>
      <address>
        <city>Kurashiki</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Matsumoto Medical Center</name>
      <address>
        <city>Matsumoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hyogo College Of Medicine College Hospital</name>
      <address>
        <city>Nishinomiya</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Saiseikai Nakatsu Hospital</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Center Hospital of the National Center for Global Health and Medicine, National Research and Development Agency</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hiratsuka stomach and intestines Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nippon Medical School Hospital</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Yokohama Medical Center</name>
      <address>
        <city>Yokohama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yokohama City University Hospital</name>
      <address>
        <city>Yokohama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>March 28, 2019</last_update_submitted>
  <last_update_submitted_qc>March 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 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>Calcium</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/NCT03284177
org study id: 334-103-00001
secondary id: JapicCTI-173713
nct id: NCT03284177
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To investigate the safety of C13-CAC and the relationship among C13-CAC breath test, gastric
      pH, and the improvement of symptoms by switching PPI in PPI resistant GERD patients
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: 13CO2 concentration in expired air.
time frame: 5，10，15，20，25 and 30 minutes after C13-CAC administration.
description: Sensitivity and specificity of 13CO2 concentration in expired air for improvement of symptoms.
measure: Gastric pH
time frame: 1 hour prior to C13-CAC administration
description: Sensitivity and specificity of mean gastric pH for improvement of symptoms.
arm group label: C13-CAC
arm group type: Experimental
intervention type: Drug
intervention name: Calcium (13C)Carbonate
description: C13-CAC breath test containing Calcium (13C) Carbonate was performed twice under fasting conditions.
arm group label: C13-CAC
intervention type: Drug
intervention name: Gastric acid inhibitors
description: Gastric acid inhibitor was orally administrated once daily for 4weeks after first C13-CAC breath test.
arm group label: C13-CAC
intervention type: Other
intervention name: Gastric pH monitoring
description: Gastric pH monitoring was performed once under fasting condition.
arm group label: C13-CAC
criteria: 
gender: All
minimum age: 20 Years
maximum age: 89 Years
healthy volunteers: No
facility: 
facility: 
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country: Japan
responsible party type: Sponsor
mesh term: Gastroesophageal Reflux
mesh term: Calcium
sharing ipd: No