<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/NCT01677338</url>
  </required_header>
  <id_info>
    <org_study_id>URA-12-001</org_study_id>
    <nct_id>NCT01677338</nct_id>
  </id_info>
  <brief_title>Phase 2 Study to Evaluate the Preliminary Performance of the C13-URA Breath Test Kit in Dyspeptic Subjects</brief_title>
  <official_title>A Multi-center, Open-label Comparison Study of a 13C-uracil Breath Test Versus 99mTechnetium Sulfur Colloid Gastric Emptying Scintigraphy to Evaluate Normal, and Delayed Gastric Emptying Time in Dyspeptic Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Otsuka Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Covance</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Otsuka Pharmaceutical Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a multi-center, open-label comparison study and aimed to evaluate the&#xD;
      preliminary performance of this 13C-uracil GEBT to examine its abilities of identifying&#xD;
      abnormal (delayed) gastric emptying rates in subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Approximately equal numbers of subjects will be enrolled in each of the 2 groups (with normal&#xD;
      gastric emptying, and with delayed gastric emptying (gastroparesis)) to complete at least 10&#xD;
      subjects per group.&#xD;
&#xD;
      The subjects will first have their gastric emptying rates investigated by scintigraphy using&#xD;
      the Solid Test Meal containing 500 uCi 99mTc sulfur colloid at Visit 1. Second, the subjects&#xD;
      will have their gastric emptying rates investigated by scintigraphy and 13C-uracil GEBT&#xD;
      simultaneously using the Semi solid Test Meal containing 500 uCi 99mTc sulfur colloid and 100&#xD;
      mg of 13C-uracil, respectively, at Visit 2. A comparison will be made between the results&#xD;
      obtained at Visits 1 and 2 along with a comparison of the data obtained during Visit 2 for&#xD;
      evaluation of the 13C-uracil GEBT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">June 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>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Expired 13CO2 concentrations</measure>
    <time_frame>6 hours</time_frame>
    <description>Expired 13CO2 concentrations are obtained from breath test. The values will be calculated to Re(t)[B] semi-solid: remaining (%) of semi-solid test meal in stomach at t, t1/2[B] semi solid: half emptying time of semi-solid test meal , and tlag[B] semi-solid: lag time of semi-solid test meal.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentrations of 13C-uracil and its major metabolites in plasma and urine</measure>
    <time_frame>6 hours</time_frame>
    <description>PK parameters of 13C-uracil and its major metabolites, DHU and UPA, including AUCt, AUC∞, Cmax, tmax, λz, and t1/2,z, will be calculated based on plasma and urine concentration for 13C-uracil and its metabolites, and expired 13CO2-excretion, which calculated based on expired 13CO2 concentrations</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Dyspeptic Subjects</condition>
  <arm_group>
    <arm_group_label>13C-uracil and 99mTc sulfur colloid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will consume the Semi-solid Test Meal containing 500 uCi 99mTc sulfur colloid and 100 mg of 13C-uracil.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>99mTc sulfur colloid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will consume the Solid Test Meal containing 500 uCi 99mTc sulfur colloid.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>13C-uracil</intervention_name>
    <description>PO, the Semi-solid Test Meal containing 100 mg of 13C-uracil . Perform the Breath Test.</description>
    <arm_group_label>13C-uracil and 99mTc sulfur colloid</arm_group_label>
    <other_name>C13-URA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>99mTc sulfur colloid</intervention_name>
    <description>PO, the Solid Test Meal containing 500 uCi 99mTc sulfur colloid. Perform the Scintigraphy.</description>
    <arm_group_label>13C-uracil and 99mTc sulfur colloid</arm_group_label>
    <arm_group_label>99mTc sulfur colloid</arm_group_label>
    <other_name>Technetium Tc 99m Sulfur Colloid Injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index [range is 18.0 to 33.0 kg/m2&#xD;
&#xD;
          -  Subjects with any upper GI symptoms&#xD;
&#xD;
          -  Stable creatinine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of known peptic ulcers or stomach cancer.&#xD;
&#xD;
          -  History of stomach surgery or resection&#xD;
&#xD;
          -  History of significant hypersensitivity, intolerance, or allergy to any drug compound,&#xD;
             food or other substance, unless approved by the investigator&#xD;
&#xD;
          -  History of alcoholism or drug abuse&#xD;
&#xD;
          -  History or presence of clinically significant GI, cardiovascular, central nervous&#xD;
             system, hepatic, or renal disease; or other conditions&#xD;
&#xD;
          -  History of eating disorders&#xD;
&#xD;
          -  History or presence of an abnormal ECG, which, in the opinion of the investigator, is&#xD;
             clinically significant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</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>Compass Research</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center, Gastroenterology and Hepatology</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <disposition_first_submitted>October 20, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>November 11, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">December 10, 2015</disposition_first_posted>
  <last_update_submitted>April 1, 2019</last_update_submitted>
  <last_update_submitted_qc>April 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Technetium Tc 99m Sulfur Colloid</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT01677338
org study id: URA-12-001
nct id: NCT01677338
lead sponsor: 
collaborator: 
has dmc: No
This study is a multi-center, open-label comparison study and aimed to evaluate the
      preliminary performance of this 13C-uracil GEBT to examine its abilities of identifying
      abnormal (delayed) gastric emptying rates in subjects.
Approximately equal numbers of subjects will be enrolled in each of the 2 groups (with normal
      gastric emptying, and with delayed gastric emptying (gastroparesis)) to complete at least 10
      subjects per group.

      The subjects will first have their gastric emptying rates investigated by scintigraphy using
      the Solid Test Meal containing 500 uCi 99mTc sulfur colloid at Visit 1. Second, the subjects
      will have their gastric emptying rates investigated by scintigraphy and 13C-uracil GEBT
      simultaneously using the Semi solid Test Meal containing 500 uCi 99mTc sulfur colloid and 100
      mg of 13C-uracil, respectively, at Visit 2. A comparison will be made between the results
      obtained at Visits 1 and 2 along with a comparison of the data obtained during Visit 2 for
      evaluation of the 13C-uracil GEBT.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Expired 13CO2 concentrations
time frame: 6 hours
description: Expired 13CO2 concentrations are obtained from breath test. The values will be calculated to Re(t)[B] semi-solid: remaining (%) of semi-solid test meal in stomach at t, t1/2[B] semi solid: half emptying time of semi-solid test meal , and tlag[B] semi-solid: lag time of semi-solid test meal.
measure: Concentrations of 13C-uracil and its major metabolites in plasma and urine
time frame: 6 hours
description: PK parameters of 13C-uracil and its major metabolites, DHU and UPA, including AUCt, AUC∞, Cmax, tmax, λz, and t1/2,z, will be calculated based on plasma and urine concentration for 13C-uracil and its metabolites, and expired 13CO2-excretion, which calculated based on expired 13CO2 concentrations
arm group label: 13C-uracil and 99mTc sulfur colloid
arm group type: Experimental
description: Subjects will consume the Semi-solid Test Meal containing 500 uCi 99mTc sulfur colloid and 100 mg of 13C-uracil.
arm group label: 99mTc sulfur colloid
arm group type: Experimental
description: Subjects will consume the Solid Test Meal containing 500 uCi 99mTc sulfur colloid.
intervention type: Drug
intervention name: 13C-uracil
description: PO, the Semi-solid Test Meal containing 100 mg of 13C-uracil . Perform the Breath Test.
arm group label: 13C-uracil and 99mTc sulfur colloid
other name: C13-URA
intervention type: Drug
intervention name: 99mTc sulfur colloid
description: PO, the Solid Test Meal containing 500 uCi 99mTc sulfur colloid. Perform the Scintigraphy.
arm group label: 13C-uracil and 99mTc sulfur colloid
arm group label: 99mTc sulfur colloid
other name: Technetium Tc 99m Sulfur Colloid Injection
criteria: 
gender: All
minimum age: 21 Years
maximum age: 65 Years
healthy volunteers: No
last name: Kimiyoshi Sudoh
role: Study Director
affiliation: Otsuka Pharmaceutical Co., Ltd.
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Technetium Tc 99m Sulfur Colloid