<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/NCT01668927</url>
  </required_header>
  <id_info>
    <org_study_id>rjkls_2012009</org_study_id>
    <nct_id>NCT01668927</nct_id>
  </id_info>
  <brief_title>Empirical Rescue Therapies of Helicobacter Pylori Infection</brief_title>
  <official_title>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>
      The increase of antibiotic resistance to H. pylori causes failure of treatment. Furazolidone,&#xD;
      amoxicillin and tetracycline are good candidates for rescue therapy since resistance to these&#xD;
      three antimicrobials was rare. It is necessary to assess the efficacy and safety of these&#xD;
      four bismuth-containing quadruple regimens with above antibiotics as empirical rescue&#xD;
      therapies for H. pylori eradication.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">September 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 H. pylori</measure>
    <time_frame>2 months</time_frame>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">424</enrollment>
  <condition>Functional Dyspepsia</condition>
  <condition>Scarred Peptic Ulcer</condition>
  <arm_group>
    <arm_group_label>tetracycline/furazolidone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>one of the four empirical rescue therapies</description>
  </arm_group>
  <arm_group>
    <arm_group_label>amoxicillin/tetracycline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>one of the four empirical rescue therapies</description>
  </arm_group>
  <arm_group>
    <arm_group_label>amoxicillin/furazolidone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>one of the four empirical rescue therapies</description>
  </arm_group>
  <arm_group>
    <arm_group_label>tetracycline /metronidazole</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Classical rescue therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Proton Pump Inhibitor</intervention_name>
    <arm_group_label>amoxicillin/furazolidone</arm_group_label>
    <arm_group_label>amoxicillin/tetracycline</arm_group_label>
    <arm_group_label>tetracycline /metronidazole</arm_group_label>
    <arm_group_label>tetracycline/furazolidone</arm_group_label>
    <other_name>Lansoprazole</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bismuth</intervention_name>
    <arm_group_label>amoxicillin/furazolidone</arm_group_label>
    <arm_group_label>amoxicillin/tetracycline</arm_group_label>
    <arm_group_label>tetracycline /metronidazole</arm_group_label>
    <arm_group_label>tetracycline/furazolidone</arm_group_label>
    <other_name>Bismuth potassium citrate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metronidazole</intervention_name>
    <arm_group_label>tetracycline /metronidazole</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tetracycline</intervention_name>
    <arm_group_label>amoxicillin/tetracycline</arm_group_label>
    <arm_group_label>tetracycline /metronidazole</arm_group_label>
    <arm_group_label>tetracycline/furazolidone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Furazolidone</intervention_name>
    <arm_group_label>amoxicillin/furazolidone</arm_group_label>
    <arm_group_label>tetracycline/furazolidone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amoxicillin</intervention_name>
    <arm_group_label>amoxicillin/furazolidone</arm_group_label>
    <arm_group_label>amoxicillin/tetracycline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  H. pylori -positive patients with functional dyspepsia and scarred peptic ulcers who&#xD;
             had previously failed one or more eradication regimens containing clarithromycin,&#xD;
             metronidazole and/or amoxicillin.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  less than 18 years old, never receiving eradication treatment before, with previous&#xD;
             gastric surgery, pregnancy, lactation, major systemic diseases, administration of&#xD;
             antibiotics, bismuth, antisecretory drugs in the preceding 8 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 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, Renji Hospital</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>Amoxicillin</mesh_term>
    <mesh_term>Metronidazole</mesh_term>
    <mesh_term>Tetracycline</mesh_term>
    <mesh_term>Furazolidone</mesh_term>
    <mesh_term>Potassium Citrate</mesh_term>
    <mesh_term>Lansoprazole</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/NCT01668927
org study id: rjkls_2012009
nct id: NCT01668927
lead sponsor: 
has dmc: No
The increase of antibiotic resistance to H. pylori causes failure of treatment. Furazolidone,
      amoxicillin and tetracycline are good candidates for rescue therapy since resistance to these
      three antimicrobials was rare. It is necessary to assess the efficacy and safety of these
      four bismuth-containing quadruple regimens with above antibiotics as empirical rescue
      therapies for H. pylori eradication.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: eradication rate of H. pylori
time frame: 2 months
arm group label: tetracycline/furazolidone
arm group type: Experimental
description: one of the four empirical rescue therapies
arm group label: amoxicillin/tetracycline
arm group type: Experimental
description: one of the four empirical rescue therapies
arm group label: amoxicillin/furazolidone
arm group type: Experimental
description: one of the four empirical rescue therapies
arm group label: tetracycline /metronidazole
arm group type: Active Comparator
description: Classical rescue therapy
intervention type: Drug
intervention name: Proton Pump Inhibitor
arm group label: amoxicillin/furazolidone
arm group label: amoxicillin/tetracycline
arm group label: tetracycline /metronidazole
arm group label: tetracycline/furazolidone
other name: Lansoprazole
intervention type: Drug
intervention name: Bismuth
arm group label: amoxicillin/furazolidone
arm group label: amoxicillin/tetracycline
arm group label: tetracycline /metronidazole
arm group label: tetracycline/furazolidone
other name: Bismuth potassium citrate
intervention type: Drug
intervention name: Metronidazole
arm group label: tetracycline /metronidazole
intervention type: Drug
intervention name: Tetracycline
arm group label: amoxicillin/tetracycline
arm group label: tetracycline /metronidazole
arm group label: tetracycline/furazolidone
intervention type: Drug
intervention name: Furazolidone
arm group label: amoxicillin/furazolidone
arm group label: tetracycline/furazolidone
intervention type: Drug
intervention name: Amoxicillin
arm group label: amoxicillin/furazolidone
arm group label: amoxicillin/tetracycline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
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, Renji Hospital
mesh term: Peptic Ulcer
mesh term: Dyspepsia
mesh term: Amoxicillin
mesh term: Metronidazole
mesh term: Tetracycline
mesh term: Furazolidone
mesh term: Potassium Citrate
mesh term: Lansoprazole
mesh term: Bismuth
mesh term: Proton Pump Inhibitors