<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/NCT02264587</url>
  </required_header>
  <id_info>
    <org_study_id>GAS-IIS-2013-03</org_study_id>
    <nct_id>NCT02264587</nct_id>
  </id_info>
  <brief_title>Effects and Mechanism of Mosapride Citrate on Diabetic Gastroparesis</brief_title>
  <acronym>MDGP</acronym>
  <official_title>Effects and Mechanism of Mosapride Citrate on Diabetic Gastroparesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Liangzhou Wei</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sumitomo Pharma (Suzhou) Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Qingdao University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effects and mechanism of mosapride citrate on&#xD;
      diabetic gastroparesi.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate the effect of mosapride on DPG by 13 C - octylic acid breath test.&#xD;
&#xD;
      IF C13- octylic acid be absorbed by mucous membrane of small intestine, octylic acid will be&#xD;
      oxidated to CO2.Patients eating food containing C13, and then collect their expired gas at&#xD;
      15, 30,45,60,75,90,105,120,150,180,210,240min, analyse the mass of C13 by mass spectrometer,&#xD;
      then can calculate the gastric emptying rate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">September 2015</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The improvement of gastric emptying time after taking the medicine</measure>
    <time_frame>2 weeks</time_frame>
    <description>Gastric emptying time will be tested by C13 breath test.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Diabetic Gastroparesis</condition>
  <arm_group>
    <arm_group_label>mosapride</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>mosapride 5mg by mouth, 30 minutes before meals, every times one day for 14days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>domperidone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>domperidone 10mg by mouth, 30 minutes before meals, every times one day for 14days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mosapride</intervention_name>
    <description>Mosapride 5mg by mouth ,3 times one day for 1 4days.</description>
    <arm_group_label>mosapride</arm_group_label>
    <other_name>Gasmotin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>domperidone</intervention_name>
    <description>Domperidone 10mg by mouth ,3 times one day for 1 4days.</description>
    <arm_group_label>domperidone</arm_group_label>
    <other_name>Motilium</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18≤ age ≤ 75&#xD;
&#xD;
          2. Patients coincided to, the WHO diagnostic criteria for diabetes in 1999 (namely have&#xD;
             diabetes symptoms, plasma glucose tendency for 11.1 / L, at any time or fasting plasma&#xD;
             glucose tendency for 7.0 / L, or oral glucose tolerance test 2 h plasma glucose levels&#xD;
             tendency for 11.1 / L）&#xD;
&#xD;
          3. fasting blood-glucose≤7.0mmol/L and 2h postprandial plasma glucose≤10.0mmol/L&#xD;
&#xD;
          4. Be diagnosed diabetes more than 5 years, blood sugar steady in one month.&#xD;
&#xD;
          5. have the following symptoms for over 4weeks: early satiety ,postprandial fullness&#xD;
             ,nausea, vomting,abdominal distension,belching, inappetence, epigastric pain,&#xD;
             constipation.&#xD;
&#xD;
          6. Be diagnosed as Delayed Gastric Emptying by C13 breath test.&#xD;
&#xD;
          7. Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. take gastrointestinal drugs within 2 weeks prior to screening. Or patients with other&#xD;
             digestive disease.&#xD;
&#xD;
          2. All patients will be administrated gastroscope in order to exclude stomach or duodenum&#xD;
             disease, pyloric obstruction. It's normal in Liver, gallbladder, pancreas,spleen,&#xD;
             nephridium by Ultrasound examination .&#xD;
&#xD;
          3. Serious ketoacidosis.&#xD;
&#xD;
          4. History of abdominal operation.&#xD;
&#xD;
          5. Thyroid hypofunction or hyperthyroidism.&#xD;
&#xD;
          6. nervous system disease or autoimmune diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>October 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 14, 2014</last_update_submitted>
  <last_update_submitted_qc>October 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Qingdao University</investigator_affiliation>
    <investigator_full_name>Liangzhou Wei</investigator_full_name>
    <investigator_title>Head of departments</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroparesis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Domperidone</mesh_term>
    <mesh_term>Mosapride</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/NCT02264587
org study id: GAS-IIS-2013-03
nct id: NCT02264587
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to evaluate the effects and mechanism of mosapride citrate on
      diabetic gastroparesi.
To evaluate the effect of mosapride on DPG by 13 C - octylic acid breath test.

      IF C13- octylic acid be absorbed by mucous membrane of small intestine, octylic acid will be
      oxidated to CO2.Patients eating food containing C13, and then collect their expired gas at
      15, 30,45,60,75,90,105,120,150,180,210,240min, analyse the mass of C13 by mass spectrometer,
      then can calculate the gastric emptying rate.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The improvement of gastric emptying time after taking the medicine
time frame: 2 weeks
description: Gastric emptying time will be tested by C13 breath test.
arm group label: mosapride
arm group type: Experimental
description: mosapride 5mg by mouth, 30 minutes before meals, every times one day for 14days
arm group label: domperidone
arm group type: Active Comparator
description: domperidone 10mg by mouth, 30 minutes before meals, every times one day for 14days
intervention type: Drug
intervention name: Mosapride
description: Mosapride 5mg by mouth ,3 times one day for 1 4days.
arm group label: mosapride
other name: Gasmotin
intervention type: Drug
intervention name: domperidone
description: Domperidone 10mg by mouth ,3 times one day for 1 4days.
arm group label: domperidone
other name: Motilium
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Qingdao University
investigator full name: Liangzhou Wei
investigator title: Head of departments
mesh term: Gastroparesis
mesh term: Domperidone
mesh term: Mosapride