<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/NCT04403087</url>
  </required_header>
  <id_info>
    <org_study_id>BCSHPAE</org_study_id>
    <nct_id>NCT04403087</nct_id>
  </id_info>
  <brief_title>Trimebutine on the Development of Adverse Events Related to the Helicobacter Pylori Eradication Medications</brief_title>
  <official_title>Additive Effect of Trimebutine on the Development of Adverse Events Related to the Helicobacter Pylori Eradication Medications; an Open-label, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chuncheon Sacred Heart Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chuncheon Sacred Heart Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adverse events related to the eradication medication is one of the reason of lower&#xD;
      eradication success in the H. pylori treatment. The aim of this study was to evaluate the&#xD;
      additive effect of trimebutine for the development of adverse events related to the H. pylori&#xD;
      eradication regimen.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adverse events related to the eradication medication is one of the reason of lower&#xD;
      eradication success in the H. pylori treatment. The common adverse events related to the&#xD;
      eradication medications area as follows; Abdomen discomfort, pain, nausea, vomiting,&#xD;
      diarrhea, bloating, urticaria, dizziness, headache, etc,. Various methods have been tried to&#xD;
      reduce or prevent the adverse events related to the eradication medications. However, there&#xD;
      is no established methods to reduce or prevent these events.&#xD;
&#xD;
      The aim of this study was to evaluate the additive effect of trimebutine for the development&#xD;
      of adverse events related to the H. pylori eradication regimen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2021</start_date>
  <completion_date type="Actual">July 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 1, 2021</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>Overall compliance of eradication medication</measure>
    <time_frame>2 weeks after prescription of eradication medication</time_frame>
    <description>How much the enrolled subjects took prescribed eradication medication</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse events related to eradication medication</measure>
    <time_frame>2 weeks and 6 weeks after prescription of eradication medication</time_frame>
    <description>percentage of Adverse events related to eradication medication</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Helicobacter Pylori Infection</condition>
  <arm_group>
    <arm_group_label>Trimebutine add group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Addition of Trimebutine on the Bismuth-containing quadruple regimen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Bismuth-containing quadruple regimen</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trimebutine 100 MG</intervention_name>
    <description>Trimebutine 100mg three times a day</description>
    <arm_group_label>Trimebutine add group</arm_group_label>
    <other_name>Polybutine (Samil Pharm.Co.,Ltd.)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who underwent upper gastrointestinal endoscopy and were proven to have H.&#xD;
             pylori infection either by using the rapid urease test, the 13 C-urea breath test&#xD;
             (UBT), or histological examination.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who took medications as Proton pump inhibitor, Histamin-2 receptor antagonist&#xD;
             and antibiotics,&#xD;
&#xD;
          -  Subjects who underwent stomach resection&#xD;
&#xD;
          -  Subjects less than 18 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chang Seok Bang, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hallym University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chuncheon Sacred Heart hospital</name>
      <address>
        <city>Chuncheon</city>
        <state>Gangwon</state>
        <zip>24253</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>July 9, 2022</last_update_submitted>
  <last_update_submitted_qc>July 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chuncheon Sacred Heart Hospital</investigator_affiliation>
    <investigator_full_name>Chang Seok Bang</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trimebutine</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/NCT04403087
org study id: BCSHPAE
nct id: NCT04403087
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Adverse events related to the eradication medication is one of the reason of lower
      eradication success in the H. pylori treatment. The aim of this study was to evaluate the
      additive effect of trimebutine for the development of adverse events related to the H. pylori
      eradication regimen.
Adverse events related to the eradication medication is one of the reason of lower
      eradication success in the H. pylori treatment. The common adverse events related to the
      eradication medications area as follows; Abdomen discomfort, pain, nausea, vomiting,
      diarrhea, bloating, urticaria, dizziness, headache, etc,. Various methods have been tried to
      reduce or prevent the adverse events related to the eradication medications. However, there
      is no established methods to reduce or prevent these events.

      The aim of this study was to evaluate the additive effect of trimebutine for the development
      of adverse events related to the H. pylori eradication regimen.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall compliance of eradication medication
time frame: 2 weeks after prescription of eradication medication
description: How much the enrolled subjects took prescribed eradication medication
measure: Adverse events related to eradication medication
time frame: 2 weeks and 6 weeks after prescription of eradication medication
description: percentage of Adverse events related to eradication medication
arm group label: Trimebutine add group
arm group type: Experimental
description: Addition of Trimebutine on the Bismuth-containing quadruple regimen
arm group label: Control group
arm group type: No Intervention
description: Bismuth-containing quadruple regimen
intervention type: Drug
intervention name: Trimebutine 100 MG
description: Trimebutine 100mg three times a day
arm group label: Trimebutine add group
other name: Polybutine (Samil Pharm.Co.,Ltd.)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Chang Seok Bang, MD, PHD
role: Principal Investigator
affiliation: Hallym University
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Chuncheon Sacred Heart Hospital
investigator full name: Chang Seok Bang
investigator title: Associate professor
mesh term: Trimebutine
sharing ipd: No