<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/NCT03779074</url>
  </required_header>
  <id_info>
    <org_study_id>VGHKS18-CT4-24</org_study_id>
    <nct_id>NCT03779074</nct_id>
  </id_info>
  <brief_title>Comparing the Efficacy of Hybrid, High-dose Dual and Bismuth Quadruple Therapies</brief_title>
  <official_title>Efficacies of Hybrid, High-dose Dual and Bismuth Quadruple Therapies for the First-line Anti-H Pylori Treatment and Tetracycline-levofloxacin Quadruple Therapy for the Second-line Anti-H Pylori Treatment - a Multicentre Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaohsiung Veterans General Hospital.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaohsiung Veterans General Hospital.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Both hybrid and high-dose dual therapies developed by the scholars from Taiwan can achieve a&#xD;
      high eradication rate for clarithromycin-resistant strains, and have a great potential to&#xD;
      replace bismuth quadruple therapy in the treatment of H. pylori infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bismuth quadruple therapy has been recommended as a choice of the first-line treatment for H.&#xD;
      pylori infection in several important international consensuses. However, it is associated&#xD;
      with a high frequency of adverse events. Both hybrid and high-dose dual therapies developed&#xD;
      by the scholars from Taiwan can achieve a high eradication rate for clarithromycin-resistant&#xD;
      strains, and have a great potential to replace bismuth quadruple therapy in the treatment of&#xD;
      H. pylori infection. In the second-line treatment, tetracycline-levofloxacin quadruple&#xD;
      therapy developed by our study group can achieve a higher eradication rate than levofloxacin&#xD;
      triple therapy for salvage treatment of hybrid therapy. However, whether the new therapy can&#xD;
      be a promising rescue treatment for bismuth quadruple or high-dose dual therapy remains&#xD;
      unanswered.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 3, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2022</primary_completion_date>
  <phase>Phase 3</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>3</number_of_arms>
  <enrollment type="Anticipated">918</enrollment>
  <condition>Helicobacter Pylori Infection</condition>
  <arm_group>
    <arm_group_label>10d bismuth quadruple therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>rabeprazole 20 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>14d hybrid therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>a dual regimen with rabeprazole 20 mg and amoxicillin 1 g b.i.d. for 7 days followed by a quadruple regimen with rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg b.i.d. for 7 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>14d high-dose dual therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>rabeprazole 20 mg and amoxicillin 750 mg q.i.d. for 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>10d bismuth quadruple therapy</intervention_name>
    <description>rabeprazole 20 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_label>10d bismuth quadruple therapy</arm_group_label>
    <other_name>rabeprazole 20 mg bid</other_name>
    <other_name>tripotassium dicitrate bismuthate 300mg qid</other_name>
    <other_name>tetracycline 500 mg qid</other_name>
    <other_name>metronidazole 250 mg qid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>14d hybrid therapy</intervention_name>
    <description>a dual regimen with rabeprazole 20 mg and amoxicillin 1 g b.i.d. for 7 days followed by a quadruple regimen with rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg b.i.d. for 7 days</description>
    <arm_group_label>14d hybrid therapy</arm_group_label>
    <other_name>rabeprazole 20 mg bid</other_name>
    <other_name>amoxicillin 1 g bid</other_name>
    <other_name>clarithromycin 500 mg bid</other_name>
    <other_name>metronidazole 500 mg bid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>14D high-dose dual therapy</intervention_name>
    <description>rabeprazole 20 mg and amoxicillin 750 mg q.i.d. for 14 days</description>
    <arm_group_label>14d high-dose dual therapy</arm_group_label>
    <other_name>rabeprazole 20 mg qid</other_name>
    <other_name>amoxicillin 750 mg qid</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive H pylori-infected outpatients, at least 20 years of age, with&#xD;
             endoscopically proven peptic ulcer diseases or gastritis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous H pylori-eradication therapy&#xD;
&#xD;
          -  ingestion of antibiotics or bismuth within the prior 4 weeks&#xD;
&#xD;
          -  patients with allergic history to the medications used&#xD;
&#xD;
          -  patients with previous gastric surgery&#xD;
&#xD;
          -  the coexistence of serious concomitant illness (for example, decompensated liver&#xD;
             cirrhosis, uremia)&#xD;
&#xD;
          -  pregnant women&#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>
  <overall_contact_backup>
    <last_name>Feng-woei Tsay, Bachelor</last_name>
    <phone>+886-7-342-2121</phone>
    <phone_ext>8233</phone_ext>
    <email>fwchaie@vghks.gov.tw</email>
  </overall_contact_backup>
  <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>
      <phone>886-7346-8233</phone>
      <email>williamhsup@yahoo.com.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>March 2022</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 11, 2022</last_update_submitted>
  <last_update_submitted_qc>March 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal 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>
  <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>Clarithromycin</mesh_term>
    <mesh_term>Tetracycline</mesh_term>
    <mesh_term>Rabeprazole</mesh_term>
    <mesh_term>Bismuth</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/NCT03779074
org study id: VGHKS18-CT4-24
nct id: NCT03779074
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Both hybrid and high-dose dual therapies developed by the scholars from Taiwan can achieve a
      high eradication rate for clarithromycin-resistant strains, and have a great potential to
      replace bismuth quadruple therapy in the treatment of H. pylori infection.
Bismuth quadruple therapy has been recommended as a choice of the first-line treatment for H.
      pylori infection in several important international consensuses. However, it is associated
      with a high frequency of adverse events. Both hybrid and high-dose dual therapies developed
      by the scholars from Taiwan can achieve a high eradication rate for clarithromycin-resistant
      strains, and have a great potential to replace bismuth quadruple therapy in the treatment of
      H. pylori infection. In the second-line treatment, tetracycline-levofloxacin quadruple
      therapy developed by our study group can achieve a higher eradication rate than levofloxacin
      triple therapy for salvage treatment of hybrid therapy. However, whether the new therapy can
      be a promising rescue treatment for bismuth quadruple or high-dose dual therapy remains
      unanswered.
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 bismuth quadruple therapy
arm group type: Active Comparator
description: rabeprazole 20 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: 14d hybrid therapy
arm group type: Experimental
description: a dual regimen with rabeprazole 20 mg and amoxicillin 1 g b.i.d. for 7 days followed by a quadruple regimen with rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg b.i.d. for 7 days.
arm group label: 14d high-dose dual therapy
arm group type: Experimental
description: rabeprazole 20 mg and amoxicillin 750 mg q.i.d. for 14 days
intervention type: Drug
intervention name: 10d bismuth quadruple therapy
description: rabeprazole 20 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 bismuth quadruple therapy
other name: rabeprazole 20 mg bid
other name: tripotassium dicitrate bismuthate 300mg qid
other name: tetracycline 500 mg qid
other name: metronidazole 250 mg qid
intervention type: Drug
intervention name: 14d hybrid therapy
description: a dual regimen with rabeprazole 20 mg and amoxicillin 1 g b.i.d. for 7 days followed by a quadruple regimen with rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg b.i.d. for 7 days
arm group label: 14d hybrid therapy
other name: rabeprazole 20 mg bid
other name: amoxicillin 1 g bid
other name: clarithromycin 500 mg bid
other name: metronidazole 500 mg bid
intervention type: Drug
intervention name: 14D high-dose dual therapy
description: rabeprazole 20 mg and amoxicillin 750 mg q.i.d. for 14 days
arm group label: 14d high-dose dual therapy
other name: rabeprazole 20 mg qid
other name: amoxicillin 750 mg qid
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
last name: Feng-woei Tsay, Bachelor
phone: +886-7-342-2121
phone ext: 8233
email: fwchaie@vghks.gov.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Kaohsiung Veterans General Hospital.
investigator full name: Ping-I (William) Hsu, M.D.
investigator title: Professor
mesh term: Amoxicillin
mesh term: Metronidazole
mesh term: Clarithromycin
mesh term: Tetracycline
mesh term: Rabeprazole
mesh term: Bismuth