<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/NCT01667718</url>
  </required_header>
  <id_info>
    <org_study_id>rjkls2012011</org_study_id>
    <nct_id>NCT01667718</nct_id>
  </id_info>
  <brief_title>Bismuth Improves the Efficacy of Levofloxacin-containing Triple Therapy for Helicobacter Pylori Treatment</brief_title>
  <official_title>Levofloxacin-containing Therapy for Helicobacter Pylori Treatment</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and&#xD;
      without Bismuth for H.pylori treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The success rate of the standard triple therapy for H. pylori infection is decreasing&#xD;
      recently.Fluoroquinolone has been proposed to replace clarithromycin as an alternative in the&#xD;
      treatment. However prevalence of H.pylori resistance to Levofloxacin has increased rapidly in&#xD;
      our area. The purpose of this study is to observe the efficacy of 14 day Levofloxacin triple&#xD;
      therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">October 2012</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>eradication rate of Helicobacter pylori</measure>
    <time_frame>2 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">161</enrollment>
  <condition>Functional Dyspepsia</condition>
  <condition>Peptic Ulcer</condition>
  <arm_group>
    <arm_group_label>Levofloxacin-triple therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Levofloxacin-quadruple therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bismuth</intervention_name>
    <description>Bismuth 220mg b.i.d for 2 weeks</description>
    <arm_group_label>Levofloxacin-quadruple therapy</arm_group_label>
    <other_name>Bismuth potassium citrate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lansoprazole</intervention_name>
    <description>Lansoprazole 30 mg b.i.d.for 2 weeks</description>
    <arm_group_label>Levofloxacin-quadruple therapy</arm_group_label>
    <arm_group_label>Levofloxacin-triple therapy</arm_group_label>
    <other_name>Proton Pump Inhibitor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levoﬂoxacin</intervention_name>
    <description>Levoﬂoxacin 0.5 q.d. for 2 weeks</description>
    <arm_group_label>Levofloxacin-quadruple therapy</arm_group_label>
    <arm_group_label>Levofloxacin-triple therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amoxicillin</intervention_name>
    <description>Amoxicillin 1 g b.i.d. for 2 weeks</description>
    <arm_group_label>Levofloxacin-quadruple therapy</arm_group_label>
    <arm_group_label>Levofloxacin-triple therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who presented with upper gastrointestinal symptoms and endoscopically proven&#xD;
             H.pylori-positive functional dyspepsia and scarred peptic ulcer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with peptic ulcer, previous H.pylori eradication therapy, previous gastric&#xD;
             surgery, pregnancy, lactation, major systemic diseases, receipt of anti-secretory&#xD;
             therapy, antibiotics or bismuth in the preceding 4 weeks, or allergy to any one of the&#xD;
             medications&#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</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Jiao-Tong University School of Medicine Renji Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Jiao-Tong University School of Medicine Renji Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200127</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>June 5, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>December 12, 2012</last_update_submitted>
  <last_update_submitted_qc>December 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2012</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>Dr. HONG LU</investigator_full_name>
    <investigator_title>Professor of GI Division</investigator_title>
  </responsible_party>
  <keyword>eradication</keyword>
  <keyword>helicobacter pylori</keyword>
  <keyword>bismuth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peptic Ulcer</mesh_term>
    <mesh_term>Dyspepsia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amoxicillin</mesh_term>
    <mesh_term>Levofloxacin</mesh_term>
    <mesh_term>Potassium Citrate</mesh_term>
    <mesh_term>Lansoprazole</mesh_term>
    <mesh_term>Dexlansoprazole</mesh_term>
    <mesh_term>Bismuth</mesh_term>
    <mesh_term>Proton Pump Inhibitors</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/NCT01667718
org study id: rjkls2012011
nct id: NCT01667718
lead sponsor: 
has dmc: No
To examine and compare the efficacy of 2 week Levofloxacin-containing therapies with and
      without Bismuth for H.pylori treatment.
The success rate of the standard triple therapy for H. pylori infection is decreasing
      recently.Fluoroquinolone has been proposed to replace clarithromycin as an alternative in the
      treatment. However prevalence of H.pylori resistance to Levofloxacin has increased rapidly in
      our area. The purpose of this study is to observe the efficacy of 14 day Levofloxacin triple
      therapy-based, bismuth-containing quadruple therapy for H.pylori treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: eradication rate of Helicobacter pylori
time frame: 2 months
arm group label: Levofloxacin-triple therapy
arm group type: Active Comparator
description: Lansoprazole (Proton Pump Inhibitor), Levofloxacin, Amoxicillin
arm group label: Levofloxacin-quadruple therapy
arm group type: Experimental
description: Lansoprazole (Proton Pump Inhibitor),Bismuth, Levofloxacin, Amoxicillin
intervention type: Drug
intervention name: Bismuth
description: Bismuth 220mg b.i.d for 2 weeks
arm group label: Levofloxacin-quadruple therapy
other name: Bismuth potassium citrate
intervention type: Drug
intervention name: Lansoprazole
description: Lansoprazole 30 mg b.i.d.for 2 weeks
arm group label: Levofloxacin-quadruple therapy
arm group label: Levofloxacin-triple therapy
other name: Proton Pump Inhibitor
intervention type: Drug
intervention name: Levoﬂoxacin
description: Levoﬂoxacin 0.5 q.d. for 2 weeks
arm group label: Levofloxacin-quadruple therapy
arm group label: Levofloxacin-triple therapy
intervention type: Drug
intervention name: Amoxicillin
description: Amoxicillin 1 g b.i.d. for 2 weeks
arm group label: Levofloxacin-quadruple therapy
arm group label: Levofloxacin-triple therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Hong Lu
role: Principal Investigator
affiliation: Shanghai Jiao-Tong University School of Medicine Renji Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Jiao Tong University School of Medicine
investigator full name: Dr. HONG LU
investigator title: Professor of GI Division
mesh term: Peptic Ulcer
mesh term: Dyspepsia
mesh term: Amoxicillin
mesh term: Levofloxacin
mesh term: Potassium Citrate
mesh term: Lansoprazole
mesh term: Dexlansoprazole
mesh term: Bismuth
mesh term: Proton Pump Inhibitors