<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/NCT04432233</url>
  </required_header>
  <id_info>
    <org_study_id>rjkls2020031</org_study_id>
    <nct_id>NCT04432233</nct_id>
  </id_info>
  <brief_title>Intravenous Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease</brief_title>
  <official_title>Intravenous Administration of Metronidazole, Levofloxacin and Esomeprazole Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Jiao Tong University School of Medicine</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>
      Helicobacter pylori infection causes active peptic ulcer disease and related complications&#xD;
      like bleeding and pyloric obstruction. Usually, clinicians tended to treat Helicobacter&#xD;
      pylori infection after active peptic ulcer disease and related complicaitons getting healed,&#xD;
      which spent time and money. This study is designed to evaluate the efficacy and safety of&#xD;
      intravenous administration of metronidazole, levofloxacin and esomeprazole triple therapy in&#xD;
      the treatment of Helicobacter pylori infection combined with peptic ulcer disease related&#xD;
      complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Anticipated">June 15, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 15, 2021</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Helicobacter pylori eradication rate</measure>
    <time_frame>Six weeks after completion of therapy</time_frame>
    <description>Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (&lt;4‰) (4‰ as the cutoff value).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of adverse effects</measure>
    <time_frame>Within 7 days after completion of therapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of stop bleeding</measure>
    <time_frame>Within 7 days after completion of therapy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of pyloric obstruction remission</measure>
    <time_frame>Within 7 days after completion of therapy</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Helicobacter Pylori Infection</condition>
  <condition>Intravenous Drug Usage</condition>
  <arm_group>
    <arm_group_label>Intravenous therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjected enrolled will receive (a) a 10-day intravenous triple therapy containing esomeprazole 40 mg thrice a day, metronidazole 500 mg twice a day and levofloxacin 500 mg once a day and (b) esomeprazole 20 mg twice a day taken orally for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Esomeprazole</intervention_name>
    <description>Proton pump inhibitor</description>
    <arm_group_label>Intravenous therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metronidazole</intervention_name>
    <description>antibiotic for H. pylori eradication</description>
    <arm_group_label>Intravenous therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levofloxacin</intervention_name>
    <description>antibiotic for H. pylori eradication</description>
    <arm_group_label>Intravenous therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female aged between 18 and 75 years old&#xD;
&#xD;
          -  Without previous Helicobacter pylori treatment&#xD;
&#xD;
          -  Diagnosed with active peptic ulcer disease and related complications like bleeding and&#xD;
             pyloric obstruction by endoscopy examination&#xD;
&#xD;
          -  Ability and willingness to participate in the study and to sign and give informed&#xD;
             consent&#xD;
&#xD;
          -  Positive for Helicobacter pylori IgM antibody&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  With previous gastric surgery&#xD;
&#xD;
          -  Major systemic diseases&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Allergy to any of the study drugs&#xD;
&#xD;
          -  Decline to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hong Lu, PHD,MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Renji Hospital, School of Medicine, Shanghai Jiao Tong University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiao Liang, PHD,MD</last_name>
    <phone>13120839615</phone>
    <email>xliang5515@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Renji Hospital, School of Medicine, Shanghai Jiao Tong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiao Liang, PHD,MD</last_name>
      <phone>13120839615</phone>
      <email>xliang5515@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>August 25, 2020</last_update_submitted>
  <last_update_submitted_qc>August 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Hong Lu, MD</investigator_full_name>
    <investigator_title>Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Helicobacter Pylori Infection</keyword>
  <keyword>Intravenous Drug Usage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Helicobacter Infections</mesh_term>
    <mesh_term>Peptic Ulcer</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metronidazole</mesh_term>
    <mesh_term>Levofloxacin</mesh_term>
    <mesh_term>Esomeprazole</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/NCT04432233
org study id: rjkls2020031
nct id: NCT04432233
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Helicobacter pylori infection causes active peptic ulcer disease and related complications
      like bleeding and pyloric obstruction. Usually, clinicians tended to treat Helicobacter
      pylori infection after active peptic ulcer disease and related complicaitons getting healed,
      which spent time and money. This study is designed to evaluate the efficacy and safety of
      intravenous administration of metronidazole, levofloxacin and esomeprazole triple therapy in
      the treatment of Helicobacter pylori infection combined with peptic ulcer disease related
      complications.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Helicobacter pylori eradication rate
time frame: Six weeks after completion of therapy
description: Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-urea breath test. Eradication was defined as negative result from urea breath test (<4‰) (4‰ as the cutoff value).
measure: Rate of adverse effects
time frame: Within 7 days after completion of therapy
measure: Rate of stop bleeding
time frame: Within 7 days after completion of therapy
measure: Rate of pyloric obstruction remission
time frame: Within 7 days after completion of therapy
arm group label: Intravenous therapy
arm group type: Experimental
description: Subjected enrolled will receive (a) a 10-day intravenous triple therapy containing esomeprazole 40 mg thrice a day, metronidazole 500 mg twice a day and levofloxacin 500 mg once a day and (b) esomeprazole 20 mg twice a day taken orally for 8 weeks.
intervention type: Drug
intervention name: Esomeprazole
description: Proton pump inhibitor
arm group label: Intravenous therapy
intervention type: Drug
intervention name: Metronidazole
description: antibiotic for H. pylori eradication
arm group label: Intravenous therapy
intervention type: Drug
intervention name: Levofloxacin
description: antibiotic for H. pylori eradication
arm group label: Intravenous therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Hong Lu, PHD,MD
role: Principal Investigator
affiliation: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
last name: Xiao Liang, PHD,MD
phone: 13120839615
email: xliang5515@gmail.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Jiao Tong University School of Medicine
investigator full name: Hong Lu, MD
investigator title: Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Helicobacter Infections
mesh term: Peptic Ulcer
mesh term: Metronidazole
mesh term: Levofloxacin
mesh term: Esomeprazole
sharing ipd: No