<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/NCT02225067</url>
  </required_header>
  <id_info>
    <org_study_id>CAC-14-001</org_study_id>
    <nct_id>NCT02225067</nct_id>
  </id_info>
  <brief_title>Comparison Study Between C13-CAC Breath Test and 24-hour Gastric pH Monitoring</brief_title>
  <official_title>Unblinded Comparison Study for Relationship and Reproducibility Between C13-CAC Breath Test and 24-hour Gastric pH Monitoring, in Patients With Acid-related Diseases and Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Otsuka Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>EPS Corporation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Otsuka Pharmaceutical Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare C13-CAC Breath Test with 24-hour Gastric pH&#xD;
      Monitoring in Patients with Gastric Acid-related Diseases and Healthy Volunteers&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</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>5，10，15，20，25，30，40，50，60，80，100 and 120minutes after C13-CAC administration</time_frame>
    <description>13CO2 concentration in expired air, 13CO2 excretion rate in expired air as well as the pharmacokinetic parameters (Cmax, AUCt, AUC∞, tmax, λz, and t1/2) determined from the 13CO2 concentration in expired air and 13CO2 excretion rate in expired air</description>
  </primary_outcome>
  <primary_outcome>
    <measure>24-hour gastric pH</measure>
    <time_frame>from completion of pre-study examination to before C13-CAC adminitration</time_frame>
    <description>Gastric pH immediately before taking the C13-CAC and mean gastric pH from a specified time point to the time before C13-CAC administration</description>
  </primary_outcome>
  <other_outcome>
    <measure>Gastric pH holding time ratio</measure>
    <time_frame>from completion of pre-study examination to before C13-CAC adminitration</time_frame>
    <description>pH 3 holding time ratio and pH 4 holding time ratio in the 24-hour gastric pH monitoring</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Gastric Acid-related Diseases</condition>
  <condition>Healthy</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>Visit 1 and Visit 2, 24-hour gastric pH monitoring and C13-CAC breath test containing 200 mg of Calcium (13C)Carbonate</description>
    <arm_group_label>C13-CAC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with Gastric Acid-related diseases like peptic ulcer or gastroesophageal&#xD;
             reflux disease in investigator's judgment&#xD;
&#xD;
          -  Healthy subjects who are determined no history of Helicobacter pylori infections&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with hypercalcemia&#xD;
&#xD;
          -  Patients with hypothyroidism&#xD;
&#xD;
          -  Patients with hyperparathyroidism&#xD;
&#xD;
          -  History of upper gastrointestinal surgery or resection&#xD;
&#xD;
          -  Any condition would limit the subject's ability to complete 24-hour gastric pH&#xD;
             monitoring&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kimiyoshi Sudoh</last_name>
    <role>Study Director</role>
    <affiliation>Otsuka Pharmaceutical Co., Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OPHAC Hospital</name>
      <address>
        <city>Osaka</city>
        <zip>532-0003</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>May 1, 2015</last_update_submitted>
  <last_update_submitted_qc>May 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Patients</keyword>
  <keyword>Volunteers</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium</mesh_term>
  </intervention_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/NCT02225067
org study id: CAC-14-001
nct id: NCT02225067
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to compare C13-CAC Breath Test with 24-hour Gastric pH
      Monitoring in Patients with Gastric Acid-related Diseases and Healthy Volunteers
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: 13CO2 concentration in expired air
time frame: 5，10，15，20，25，30，40，50，60，80，100 and 120minutes after C13-CAC administration
description: 13CO2 concentration in expired air, 13CO2 excretion rate in expired air as well as the pharmacokinetic parameters (Cmax, AUCt, AUC∞, tmax, λz, and t1/2) determined from the 13CO2 concentration in expired air and 13CO2 excretion rate in expired air
measure: 24-hour gastric pH
time frame: from completion of pre-study examination to before C13-CAC adminitration
description: Gastric pH immediately before taking the C13-CAC and mean gastric pH from a specified time point to the time before C13-CAC administration
measure: Gastric pH holding time ratio
time frame: from completion of pre-study examination to before C13-CAC adminitration
description: pH 3 holding time ratio and pH 4 holding time ratio in the 24-hour gastric pH monitoring
arm group label: C13-CAC
arm group type: Experimental
intervention type: Drug
intervention name: Calcium (13C)Carbonate
description: Visit 1 and Visit 2, 24-hour gastric pH monitoring and C13-CAC breath test containing 200 mg of Calcium (13C)Carbonate
arm group label: C13-CAC
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kimiyoshi Sudoh
role: Study Director
affiliation: Otsuka Pharmaceutical Co., Ltd.
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Calcium