<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/NCT03779087</url>
  </required_header>
  <id_info>
    <org_study_id>VGHKS18-CT7-22</org_study_id>
    <nct_id>NCT03779087</nct_id>
  </id_info>
  <brief_title>Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection</brief_title>
  <official_title>Efficacies of Two Bismuth Quadruple Therapies in the Second-line Treatment of H Pylori Infection - a Multi-center Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ping-I (William) Hsu, M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaohsiung Veterans General 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>
      From the profiles of antibiotic susceptibility data following eradication therapy,&#xD;
      tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the&#xD;
      rescue treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The H pylori-infected adult patients with failure of standard triple therapy and H&#xD;
      pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly&#xD;
      assigned to either TL quadruple therapy (esomeprazole-bismuth-tetracycline-levofloxacin&#xD;
      regimen) or AL quadruple therapy (esomeprazole-bismuth-amoxicillin-levofloxacin regimen) for&#xD;
      10 days. Repeated endoscopy with rapid urease test, histological examination and culture or&#xD;
      urea breath tests is performed at six weeks after the end of anti-H pylori therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 11, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2021</primary_completion_date>
  <phase>N/A</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>Number of Participants in Which H. Pylori Was Eradicated</measure>
    <time_frame>sixth week after the end of anti- H. pylori therapy</time_frame>
    <description>To assess eradication efficacy,repeated endoscopy with rapid urease test, histological</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">184</enrollment>
  <condition>Helicobacter Pylori Infection</condition>
  <arm_group>
    <arm_group_label>10d TL quadruple therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>esomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, tetracycline 500 mg and metronidazole 250 mg q.i.d. for 10 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>10d AL quadruple therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>esomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, amoxicillin 500 mg and metronidazole 250 mg q.i.d. for 10 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>10d TL quadruple therapy</intervention_name>
    <description>esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, tetracycline 500 mg qid, levofloxacin 500 mg qd.</description>
    <arm_group_label>10d TL quadruple therapy</arm_group_label>
    <other_name>esomeprazole 40 mg</other_name>
    <other_name>tripotassium dicitrate bismuthate 300mg</other_name>
    <other_name>tetracycline 500 mg</other_name>
    <other_name>levofloxacin 500 mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>10d AL quadruple therapy</intervention_name>
    <description>esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, amoxicillin 500 mg qid, levofloxacin 500 mg qd.</description>
    <arm_group_label>10d AL quadruple therapy</arm_group_label>
    <other_name>esomeprazole 40 mg</other_name>
    <other_name>tripotassium dicitrate bismuthate 300mg</other_name>
    <other_name>amoxicillin 500 mg</other_name>
    <other_name>levofloxacin 500 mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive H pylori-infected outpatients, at least 20 years of age with failure of&#xD;
             first-line eradication treatments (standard triple, non-bismuth quadruple and bismuth&#xD;
             quadruple therapies)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous allergic reactions to the study medications,&#xD;
&#xD;
          -  history of gastrectomy,&#xD;
&#xD;
          -  use of antibiotics within the previous 4 weeks,&#xD;
&#xD;
          -  pregnant or lactating women,&#xD;
&#xD;
          -  coexistence of serious concomitant illness (for example, decompensated liver&#xD;
             cirrhosis, uremia, and malignancy).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ping-I Hsu, Bachelor</last_name>
    <role>Study Chair</role>
    <affiliation>Kaohsiung Veterans General Hospital.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ping-I Hsu, Bachelor</last_name>
    <phone>+886-7-342-2121</phone>
    <phone_ext>8233</phone_ext>
    <email>williamhsup@yahoo.com.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kaohsiung Veterans General Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>813</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ping I Hsu, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 16, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>March 18, 2021</last_update_submitted>
  <last_update_submitted_qc>March 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Kaohsiung Veterans General Hospital.</investigator_affiliation>
    <investigator_full_name>Ping-I (William) Hsu, M.D.</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Helicobacter pylori</keyword>
  <keyword>Eradication rate</keyword>
  <keyword>Rescue treatment</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>
  </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>Ofloxacin</mesh_term>
    <mesh_term>Tetracycline</mesh_term>
    <mesh_term>Esomeprazole</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/NCT03779087
org study id: VGHKS18-CT7-22
nct id: NCT03779087
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
From the profiles of antibiotic susceptibility data following eradication therapy,
      tetracycline, amoxicillin and levofloxacin are all good candidates of antibiotics used in the
      rescue treatment.
The H pylori-infected adult patients with failure of standard triple therapy and H
      pylori-infected adult patients with failure of non-bismuth quadruple therapy are randomly
      assigned to either TL quadruple therapy (esomeprazole-bismuth-tetracycline-levofloxacin
      regimen) or AL quadruple therapy (esomeprazole-bismuth-amoxicillin-levofloxacin regimen) for
      10 days. Repeated endoscopy with rapid urease test, histological examination and culture or
      urea breath tests is performed at six weeks after the end of anti-H pylori therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants in Which H. Pylori Was Eradicated
time frame: sixth week after the end of anti- H. pylori therapy
description: To assess eradication efficacy,repeated endoscopy with rapid urease test, histological
arm group label: 10d TL quadruple therapy
arm group type: Experimental
description: esomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, tetracycline 500 mg and metronidazole 250 mg q.i.d. for 10 days
arm group label: 10d AL quadruple therapy
arm group type: Active Comparator
description: esomeprazole 40 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, amoxicillin 500 mg and metronidazole 250 mg q.i.d. for 10 days
intervention type: Drug
intervention name: 10d TL quadruple therapy
description: esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, tetracycline 500 mg qid, levofloxacin 500 mg qd.
arm group label: 10d TL quadruple therapy
other name: esomeprazole 40 mg
other name: tripotassium dicitrate bismuthate 300mg
other name: tetracycline 500 mg
other name: levofloxacin 500 mg
intervention type: Drug
intervention name: 10d AL quadruple therapy
description: esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, amoxicillin 500 mg qid, levofloxacin 500 mg qd.
arm group label: 10d AL quadruple therapy
other name: esomeprazole 40 mg
other name: tripotassium dicitrate bismuthate 300mg
other name: amoxicillin 500 mg
other name: levofloxacin 500 mg
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
last name: Ping-I Hsu, Bachelor
role: Study Chair
affiliation: Kaohsiung Veterans General Hospital.
last name: Ping-I Hsu, Bachelor
phone: +886-7-342-2121
phone ext: 8233
email: williamhsup@yahoo.com.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor-Investigator
investigator affiliation: Kaohsiung Veterans General Hospital.
investigator full name: Ping-I (William) Hsu, M.D.
investigator title: Professor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Amoxicillin
mesh term: Levofloxacin
mesh term: Ofloxacin
mesh term: Tetracycline
mesh term: Esomeprazole