xml: <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/NCT06037122</url>
    </required_header>
    <id_info>
      <org_study_id>2023-0674</org_study_id>
      <nct_id>NCT06037122</nct_id>
    </id_info>
    <brief_title>Efficacy of Low-dose Vonoprazan for Helicobacter Pylori Eradication</brief_title>
    <official_title>Efficacy and Safety Evaluation of Bismuth-containing Quadruple Therapies Based on Low-dose Vonoprazan in the Initial Treatment of Helicobacter Pylori Infection: a Retrospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</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>
        The primary objective of this retrospective study was to assess the efficacy and safety of a&#xD;
        bismuth quadruple regimen of a low-dose potassium-competitive acid blocker versus a&#xD;
        standard-dose potassium-competitive acid blocker and a standard-dose proton pump inhibitor&#xD;
        combined with amoxicillin and clarithromycin as the initial treatment of Helicobacter pylori&#xD;
        infection.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Helicobacter pylori (H. pylori) infection is closely associated with a variety of diseases&#xD;
        including chronic gastritis, peptic ulcer, and gastric cancer. Adequate acid suppression is&#xD;
        essential for H. pylori eradication therapy. Potassium-competitive acid blocker (P-CAB)&#xD;
        vonoprazan (VPZ) has faster, stronger, and longer-lasting acid inhibition and plays an&#xD;
        important role in H. pylori treatment. 2022 Chinese national clinical practice guideline on&#xD;
        Helicobacter pylori eradication treatment recommended for the first time a quadruple regimen&#xD;
        of bismuth containing P-CAB for H. pylori eradication, in which P-CAB was administered as VPZ&#xD;
        20 mg twice daily. In this retrospective study, we compared the efficacy and safety of a&#xD;
        quadruple regimen based on low-dose P-CAB (VPZ 20 mg once daily) versus a quadruple regimen&#xD;
        based on standard-dose P-CAB (VPZ 20 mg twice daily) or standard-dose proton pump inhibitor&#xD;
        (rabeprazole 10 mg twice daily) containing amoxicillin, clarithromycin, and bismuth as&#xD;
        initial treatment for H. pylori infection. Our study will provide clinical evidence for the&#xD;
        necessary dosage of VPZ in bismuth quadruple regimens, which will help to further optimize&#xD;
        the treatment regimen for H. pylori infection.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Helicobacter H. pylori eradication rate</measure>
      <time_frame>after eradication therapy at least 4 weeks</time_frame>
      <description>number of patients successfully eradicated / the total number participants</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>safety of regimens</measure>
      <time_frame>Within 4 weeks from the beginning to the end of therapy</time_frame>
      <description>comparison of the incidence of adverse events in each group</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>compliance</measure>
      <time_frame>4 weeks after therapy completion</time_frame>
      <description>percentage of correctly administered drugs</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">558</enrollment>
    <condition>Helicobacter Pylori Infection</condition>
    <arm_group>
      <arm_group_label>group R-BID</arm_group_label>
      <description>rabeprazole 10mg, amoxicillin 1000 mg, clarithromycin 500 mg, bismuth pectin 200 mg or bismuth potassium citrate 220mg twice daily, all drugs given for 14 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>group V-BID</arm_group_label>
      <description>vonoprazan 20mg, amoxicillin 1000 mg, clarithromycin 500 mg, bismuth pectin 200 mg or bismuth potassium citrate 220mg twice daily, all drugs given for 14 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>group V-QD</arm_group_label>
      <description>vonoprazan 20mg once daily, amoxicillin 1000 mg, clarithromycin 500 mg, bismuth pectin 200 mg or bismuth potassium citrate 220mg twice daily, all drugs given for 14 days</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          The study population consisted of patients undergoing initial treatment for H. pylori&#xD;
          infection who attended the outpatient clinic of the Department of Gastroenterology at the&#xD;
          Second Hospital of Zhejiang University School of Medicine from January 1, 2021 to December&#xD;
          31, 2021. Only patients using a quadruple regimen based on rabeprazole or vonoprazan&#xD;
          combined with amoxicillin and clarithromycin with bismuth were included in the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Diagnosis of H. pylori infection confirmed by urea breath test, monoclonal fecal&#xD;
               antigen test, endoscopic biopsy histopathology, or bacterial culture;&#xD;
  &#xD;
            2. No previous eradication therapy for H. pylori;&#xD;
  &#xD;
            3. Age and gender are not restricted.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Use of acid-suppressing drugs within 2 weeks prior to treatment, or use of bismuth or&#xD;
               antibiotics (including herbal medicines with antimicrobial properties) within 4 weeks&#xD;
               prior to treatment;&#xD;
  &#xD;
            2. Known hypersensitivity to the drugs used in this study;&#xD;
  &#xD;
            3. History of esophageal or gastric surgery;&#xD;
  &#xD;
            4. Pregnant or lactating women;&#xD;
  &#xD;
            5. Serious systemic diseases, diseases of the heart, lungs, brain and other vital organs,&#xD;
               hepatic or renal insufficiency or malignant tumors (except gastric cancer);&#xD;
  &#xD;
            6. Patients unable to express their main complaints.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Qin DU</last_name>
      <role>Study Chair</role>
      <affiliation>Second Affiliated Hospital of Zhejiang University, School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Qin DU</last_name>
      <phone>+86 0571-89713734</phone>
      <email>duqin@zju.edu.cn</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Helicobacter Pylori</keyword>
    <keyword>quadruple regimen</keyword>
    <keyword>vonoprazan</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</mesh_term>
      <mesh_term>Helicobacter Infections</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>After the completion of this study, data are available upon reasonable request. Data are available from the corresponding author upon reasonable request.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>IPD Sharing will be available from June 30th 2024.</ipd_time_frame>
      <ipd_access_criteria>After the completion of this study, data are available upon reasonable request. Data are available from the corresponding author upon reasonable request.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06037122
  org study id: 2023-0674
  nct id: NCT06037122
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The primary objective of this retrospective study was to assess the efficacy and safety of a
        bismuth quadruple regimen of a low-dose potassium-competitive acid blocker versus a
        standard-dose potassium-competitive acid blocker and a standard-dose proton pump inhibitor
        combined with amoxicillin and clarithromycin as the initial treatment of Helicobacter pylori
        infection.
  Helicobacter pylori (H. pylori) infection is closely associated with a variety of diseases
        including chronic gastritis, peptic ulcer, and gastric cancer. Adequate acid suppression is
        essential for H. pylori eradication therapy. Potassium-competitive acid blocker (P-CAB)
        vonoprazan (VPZ) has faster, stronger, and longer-lasting acid inhibition and plays an
        important role in H. pylori treatment. 2022 Chinese national clinical practice guideline on
        Helicobacter pylori eradication treatment recommended for the first time a quadruple regimen
        of bismuth containing P-CAB for H. pylori eradication, in which P-CAB was administered as VPZ
        20 mg twice daily. In this retrospective study, we compared the efficacy and safety of a
        quadruple regimen based on low-dose P-CAB (VPZ 20 mg once daily) versus a quadruple regimen
        based on standard-dose P-CAB (VPZ 20 mg twice daily) or standard-dose proton pump inhibitor
        (rabeprazole 10 mg twice daily) containing amoxicillin, clarithromycin, and bismuth as
        initial treatment for H. pylori infection. Our study will provide clinical evidence for the
        necessary dosage of VPZ in bismuth quadruple regimens, which will help to further optimize
        the treatment regimen for H. pylori infection.
  observational model: Cohort
  time perspective: Retrospective
  measure: Helicobacter H. pylori eradication rate
  time frame: after eradication therapy at least 4 weeks
  description: number of patients successfully eradicated / the total number participants
  measure: safety of regimens
  time frame: Within 4 weeks from the beginning to the end of therapy
  description: comparison of the incidence of adverse events in each group
  measure: compliance
  time frame: 4 weeks after therapy completion
  description: percentage of correctly administered drugs
  arm group label: group R-BID
  description: rabeprazole 10mg, amoxicillin 1000 mg, clarithromycin 500 mg, bismuth pectin 200 mg or bismuth potassium citrate 220mg twice daily, all drugs given for 14 days
  arm group label: group V-BID
  description: vonoprazan 20mg, amoxicillin 1000 mg, clarithromycin 500 mg, bismuth pectin 200 mg or bismuth potassium citrate 220mg twice daily, all drugs given for 14 days
  arm group label: group V-QD
  description: vonoprazan 20mg once daily, amoxicillin 1000 mg, clarithromycin 500 mg, bismuth pectin 200 mg or bismuth potassium citrate 220mg twice daily, all drugs given for 14 days
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Qin DU
  role: Study Chair
  affiliation: Second Affiliated Hospital of Zhejiang University, School of Medicine
  last name: Qin DU
  phone: +86 0571-89713734
  email: duqin@zju.edu.cn
  responsible party type: Sponsor
  mesh term: Infections
  mesh term: Helicobacter Infections
  sharing ipd: Yes
  ipd description: After the completion of this study, data are available upon reasonable request. Data are available from the corresponding author upon reasonable request.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: IPD Sharing will be available from June 30th 2024.
  ipd access criteria: After the completion of this study, data are available upon reasonable request. Data are available from the corresponding author upon reasonable request.