<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/NCT01667575</url>
  </required_header>
  <id_info>
    <org_study_id>rjkls2012004</org_study_id>
    <nct_id>NCT01667575</nct_id>
  </id_info>
  <brief_title>Efficiency Study of Clarithromycin and Bismuth-containing Quadruple Therapy to Treat H.Pylori</brief_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>
      The purpose of this study is to observe the efficacy of ten day triple therapy-based,&#xD;
      bismuth-containing quadruple therapy for H.pylori treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The success rate of currently recommended triple therapy with a proton pump inhibitor (PPI)&#xD;
      plus amoxicillin and clarithromycin has fallen into the unacceptable range. The purpose of&#xD;
      this study is to observe the efficacy of ten day triple therapy-based, bismuth-containing&#xD;
      quadruple therapy for H.pylori treatment, while ten day triple therapy is used as control.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>
    <description>To calculate and compare the efficacy of 10 day and 14 day triple therapies with and without bismuth,to examine whether long duration and addition of bismuth affects the eradication.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Functional Dyspepsia</condition>
  <condition>Peptic Ulcer</condition>
  <condition>Helicobacter Pylori</condition>
  <arm_group>
    <arm_group_label>10 day Quadruple Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>10 day Triple therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Esomeprazole 20mg, Amoxicillin 1.0g,and Clarithromycin 500mg, twice a day, for ten days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>14 day quadruple therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Esomeprazole</intervention_name>
    <description>antisecretary drug of the quadruple therapy</description>
    <arm_group_label>10 day Quadruple Therapy</arm_group_label>
    <arm_group_label>10 day Triple therapy</arm_group_label>
    <arm_group_label>14 day quadruple therapy</arm_group_label>
    <other_name>proton pump inhibitor</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amoxicillin</intervention_name>
    <description>antibiotic of the quadruple therapy</description>
    <arm_group_label>10 day Quadruple Therapy</arm_group_label>
    <arm_group_label>10 day Triple therapy</arm_group_label>
    <arm_group_label>14 day quadruple therapy</arm_group_label>
    <other_name>antibiotic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clarithromycin</intervention_name>
    <description>antibiotic of the quadruple therapy</description>
    <arm_group_label>10 day Quadruple Therapy</arm_group_label>
    <arm_group_label>10 day Triple therapy</arm_group_label>
    <arm_group_label>14 day quadruple therapy</arm_group_label>
    <other_name>antibiotic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bismuth Potassium Citrate</intervention_name>
    <description>one of a component of a quadruple therapy</description>
    <arm_group_label>10 day Quadruple Therapy</arm_group_label>
    <arm_group_label>14 day quadruple therapy</arm_group_label>
    <other_name>Bismuth</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>long duration (14 day)</intervention_name>
    <arm_group_label>14 day quadruple 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 ulcers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients less than 18 years old, with history of H. pylori infection treatment, with&#xD;
             previous gastric surgery, pregnancy, lactation, major systemic diseases,&#xD;
             administration of antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks,&#xD;
             or allergy to any one of the given medication in the regimens.&#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, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>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>June 2013</verification_date>
  <study_first_submitted>August 15, 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>June 1, 2013</last_update_submitted>
  <last_update_submitted_qc>June 1, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 4, 2013</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>
  <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>Anti-Bacterial Agents</mesh_term>
    <mesh_term>Amoxicillin</mesh_term>
    <mesh_term>Clarithromycin</mesh_term>
    <mesh_term>Antibiotics, Antitubercular</mesh_term>
    <mesh_term>Potassium Citrate</mesh_term>
    <mesh_term>Esomeprazole</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/NCT01667575
org study id: rjkls2012004
nct id: NCT01667575
lead sponsor: 
has dmc: No
The purpose of this study is to observe the efficacy of ten day triple therapy-based,
      bismuth-containing quadruple therapy for H.pylori treatment.
The success rate of currently recommended triple therapy with a proton pump inhibitor (PPI)
      plus amoxicillin and clarithromycin has fallen into the unacceptable range. The purpose of
      this study is to observe the efficacy of ten day triple therapy-based, bismuth-containing
      quadruple therapy for H.pylori treatment, while ten day triple therapy is used as control.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Eradication rate of Helicobacter pylori
time frame: 2 months
description: To calculate and compare the efficacy of 10 day and 14 day triple therapies with and without bismuth,to examine whether long duration and addition of bismuth affects the eradication.
arm group label: 10 day Quadruple Therapy
arm group type: Experimental
description: Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 10 days
arm group label: 10 day Triple therapy
arm group type: Active Comparator
description: Esomeprazole 20mg, Amoxicillin 1.0g,and Clarithromycin 500mg, twice a day, for ten days
arm group label: 14 day quadruple therapy
arm group type: Active Comparator
description: Esomeprazole 20mg, Amoxicillin 1.0g, Clarithromycin 500mg and Bismuth Potassium Citrate 220mg,twice a day for 14 days
intervention type: Drug
intervention name: Esomeprazole
description: antisecretary drug of the quadruple therapy
arm group label: 10 day Quadruple Therapy
arm group label: 10 day Triple therapy
arm group label: 14 day quadruple therapy
other name: proton pump inhibitor
intervention type: Drug
intervention name: Amoxicillin
description: antibiotic of the quadruple therapy
arm group label: 10 day Quadruple Therapy
arm group label: 10 day Triple therapy
arm group label: 14 day quadruple therapy
other name: antibiotic
intervention type: Drug
intervention name: Clarithromycin
description: antibiotic of the quadruple therapy
arm group label: 10 day Quadruple Therapy
arm group label: 10 day Triple therapy
arm group label: 14 day quadruple therapy
other name: antibiotic
intervention type: Drug
intervention name: Bismuth Potassium Citrate
description: one of a component of a quadruple therapy
arm group label: 10 day Quadruple Therapy
arm group label: 14 day quadruple therapy
other name: Bismuth
intervention type: Other
intervention name: long duration (14 day)
arm group label: 14 day quadruple therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Hong Lu, M.D.
role: Principal Investigator
affiliation: Shanghai Jiao Tong University School of Medicine
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: Anti-Bacterial Agents
mesh term: Amoxicillin
mesh term: Clarithromycin
mesh term: Antibiotics, Antitubercular
mesh term: Potassium Citrate
mesh term: Esomeprazole
mesh term: Bismuth
mesh term: Proton Pump Inhibitors