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/NCT06004401</url>
    </required_header>
    <id_info>
      <org_study_id>CZHX2023.07</org_study_id>
      <nct_id>NCT06004401</nct_id>
    </id_info>
    <brief_title>The Observation on the Efficacy of Dual Therapy Based on Vonoprazan in Eradicating Helicobacter Pylori</brief_title>
    <official_title>The Observation on the Efficacy of Dual Therapy Based on Vonoprazan in Eradicating Helicobacter Pylori</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Changzheng Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Changzheng Hospital</source>
    <oversight_info>
      <has_dmc>No</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>
        Helicobacter pylori（Hp）is listed as a Class 1 carcinogen by the International Agency for&#xD;
        Research of Cancer (IARC), Eradicating Hp can significantly reduce the risk of gastric&#xD;
        cancer. In recent years, the resistance rate of Hp to antibiotics, especially Clarithromycin&#xD;
        and Metronidazole, has increased, leading to the gradual reduction of the eradication rate .&#xD;
        In addition, PPI is mainly metabolized by CYP2C19 in the body, and the genetic polymorphism&#xD;
        of this enzyme activity in the population results in significant individual differences in&#xD;
        the acid suppression effect of PPI; At the same time, PPI will affect the metabolism of other&#xD;
        drugs by affecting the activity of CYP2C19 in the liver.&#xD;
  &#xD;
        Potassium ion competitive acid blockers (P-CABs) are a new type of antacids, and vonoprazan&#xD;
        is a representative of this class of drugs. Compared to traditional proton pump inhibitors,&#xD;
        it has higher selectivity towards proton pumps, stronger acid inhibition effect, faster onset&#xD;
        time , longer sustained acid inhibition time, and less influence from food consumption.&#xD;
        Therefore, it can effectively eliminate Helicobacter pylori . In recent years, Vonoprazan has&#xD;
        been widely used in the eradication treatment of Hp . Vonoprazan can inhibit gastric acid&#xD;
        secretion more strongly and persistently, therefore, eradication plans based on vonoprazan&#xD;
        are expected to improve the eradication rate of Hp.&#xD;
  &#xD;
        Related studies have shown that compared to traditional proton pump inhibitors, vonoprazan&#xD;
        has a more significant therapeutic effect and higher safety in the treatment of Helicobacter&#xD;
        pylori positive peptic ulcers due to its unique mechanism of action..In recent years, there&#xD;
        have been reports of successful eradication of multi drug resistant Hp retreated patients&#xD;
        with Semisynthesis tetracycline. Some domestic scholars are also gradually trying to use&#xD;
        Semisynthesis tetracycline to eradicate Hp infection. Minocycline is a Semisynthesis&#xD;
        tetracycline. The drug sensitivity test in vitro showed that the resistance rate of Hp to&#xD;
        Minocycline was low , suggesting that Minocycline may have a better effect on eradicating Hp.&#xD;
  &#xD;
        Therefore, the investigators further carried out a prospective single center clinical study&#xD;
        and set up a penicillin negative group. One month after treatment, 13C carbon breath test was&#xD;
        performed to check the efficacy, in order to explore the efficacy of the combination therapy&#xD;
        based on vonoprazan in eradicating Hp, especially whether it is a good choice for penicillin&#xD;
        allergy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After one month of treatment, a 13C carbon breath test was conducted to investigate the&#xD;
        efficacy of a dual therapy based on vorolaxen in eradicating Hp, especially for those&#xD;
        allergic to penicillin.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 20, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2025</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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The eradication rate of Helicobacter pylori</measure>
      <time_frame>two years</time_frame>
      <description>whether the dual therapy based on vorolaxen has advantages over traditional quadruple therapy in penicillin negative and positive patients</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">400</enrollment>
    <condition>The Eradication Rate of Helicobacter Pylori</condition>
    <arm_group>
      <arm_group_label>Penicillin negative test group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>（Vonopazan 20mg 2//day+Amoxicillin 1.0g 3/day）*14 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Penicillin negative contral group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>（Rabeprazole tablets 10mg 2/day+colloidal pectin bismuth 200mg 2/day+Amoxicillin 1g 2/day+Clarithromycin 500mg 2/day）*14 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Penicillin positive test group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>（Vonopazan 20mg 2/day+Minocycline 100mg 2/day）*14 days</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Penicillin positive control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>（Rabeprazole tablets 10mg 2/day+colloidal pectin bismuth 200mg 2/day+Metronidazole 0.4g 3/day+Clarithromycin 500mg 2/day）*14 days</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Vonopazan +Amoxicillin</intervention_name>
      <description>Vonopazan 20mg 2//day+Amoxicillin</description>
      <arm_group_label>Penicillin negative test group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Rabeprazole +colloidal pectin bismuth +Amoxicillin +Clarithromycin</intervention_name>
      <description>Rabeprazole tablets 10mg 2/day+colloidal pectin bismuth 200mg 2/day+Amoxicillin 1g 2/day+Clarithromycin 500mg 2/day</description>
      <arm_group_label>Penicillin negative contral group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Vonopazan +Minocycline</intervention_name>
      <description>Vonopazan 20mg 2/day+Minocycline 100mg 2/day</description>
      <arm_group_label>Penicillin positive test group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Rabeprazole +colloidal pectin bismuth +Metronidazole +Clarithromycin</intervention_name>
      <description>Rabeprazole tablets 10mg 2/day+colloidal pectin bismuth 200mg 2/day+Metronidazole 0.4g 3/day+Clarithromycin 500mg 2/day</description>
      <arm_group_label>Penicillin positive control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:•&#xD;
  &#xD;
            1. Male or female aged 18-75;&#xD;
  &#xD;
            2. Initial treatment patients with Helicobacter pylori infection (positive 13C carbon&#xD;
               breath test/positive Hp in gastroscopy pathological biopsy);&#xD;
  &#xD;
            3. Not taking antibiotics, bismuth agents, or traditional Chinese medicine with&#xD;
               antibacterial effects (Isatis indigotica, berberine, honeysuckle, forsythia suspensa)&#xD;
               in the first 4 weeks; I did not take drugs that affect Hp activity such as PPI or H2&#xD;
               receptor antagonists in the first two weeks.&#xD;
  &#xD;
               -&#xD;
  &#xD;
               Exclusion Criteria:&#xD;
  &#xD;
                 -  1）Age&lt;18 years old or&gt;75 years old; 2）Pregnant and lactating women; 3）Patients&#xD;
                    with severe primary diseases such as cardiovascular, liver, kidney, and&#xD;
                    hematopoietic systems, as well as mental illness.&#xD;
  &#xD;
                    4）History of Drug allergy used in the treatment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Shanghai Changzheng Hospital</investigator_affiliation>
      <investigator_full_name>Wei-Fen Xie</investigator_full_name>
      <investigator_title>Head of gastroenterology，Shanghai Changzheng Hospital</investigator_title>
    </responsible_party>
    <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>Minocycline</mesh_term>
      <mesh_term>Rabeprazole</mesh_term>
      <mesh_term>Bismuth</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06004401
  org study id: CZHX2023.07
  nct id: NCT06004401
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Helicobacter pylori（Hp）is listed as a Class 1 carcinogen by the International Agency for
        Research of Cancer (IARC), Eradicating Hp can significantly reduce the risk of gastric
        cancer. In recent years, the resistance rate of Hp to antibiotics, especially Clarithromycin
        and Metronidazole, has increased, leading to the gradual reduction of the eradication rate .
        In addition, PPI is mainly metabolized by CYP2C19 in the body, and the genetic polymorphism
        of this enzyme activity in the population results in significant individual differences in
        the acid suppression effect of PPI; At the same time, PPI will affect the metabolism of other
        drugs by affecting the activity of CYP2C19 in the liver.
  
        Potassium ion competitive acid blockers (P-CABs) are a new type of antacids, and vonoprazan
        is a representative of this class of drugs. Compared to traditional proton pump inhibitors,
        it has higher selectivity towards proton pumps, stronger acid inhibition effect, faster onset
        time , longer sustained acid inhibition time, and less influence from food consumption.
        Therefore, it can effectively eliminate Helicobacter pylori . In recent years, Vonoprazan has
        been widely used in the eradication treatment of Hp . Vonoprazan can inhibit gastric acid
        secretion more strongly and persistently, therefore, eradication plans based on vonoprazan
        are expected to improve the eradication rate of Hp.
  
        Related studies have shown that compared to traditional proton pump inhibitors, vonoprazan
        has a more significant therapeutic effect and higher safety in the treatment of Helicobacter
        pylori positive peptic ulcers due to its unique mechanism of action..In recent years, there
        have been reports of successful eradication of multi drug resistant Hp retreated patients
        with Semisynthesis tetracycline. Some domestic scholars are also gradually trying to use
        Semisynthesis tetracycline to eradicate Hp infection. Minocycline is a Semisynthesis
        tetracycline. The drug sensitivity test in vitro showed that the resistance rate of Hp to
        Minocycline was low , suggesting that Minocycline may have a better effect on eradicating Hp.
  
        Therefore, the investigators further carried out a prospective single center clinical study
        and set up a penicillin negative group. One month after treatment, 13C carbon breath test was
        performed to check the efficacy, in order to explore the efficacy of the combination therapy
        based on vonoprazan in eradicating Hp, especially whether it is a good choice for penicillin
        allergy.
  After one month of treatment, a 13C carbon breath test was conducted to investigate the
        efficacy of a dual therapy based on vorolaxen in eradicating Hp, especially for those
        allergic to penicillin.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: The eradication rate of Helicobacter pylori
  time frame: two years
  description: whether the dual therapy based on vorolaxen has advantages over traditional quadruple therapy in penicillin negative and positive patients
  arm group label: Penicillin negative test group
  arm group type: Experimental
  description: （Vonopazan 20mg 2//day+Amoxicillin 1.0g 3/day）*14 days
  arm group label: Penicillin negative contral group
  arm group type: Active Comparator
  description: （Rabeprazole tablets 10mg 2/day+colloidal pectin bismuth 200mg 2/day+Amoxicillin 1g 2/day+Clarithromycin 500mg 2/day）*14 days
  arm group label: Penicillin positive test group
  arm group type: Experimental
  description: （Vonopazan 20mg 2/day+Minocycline 100mg 2/day）*14 days
  arm group label: Penicillin positive control group
  arm group type: Active Comparator
  description: （Rabeprazole tablets 10mg 2/day+colloidal pectin bismuth 200mg 2/day+Metronidazole 0.4g 3/day+Clarithromycin 500mg 2/day）*14 days
  intervention type: Drug
  intervention name: Vonopazan +Amoxicillin
  description: Vonopazan 20mg 2//day+Amoxicillin
  arm group label: Penicillin negative test group
  intervention type: Drug
  intervention name: Rabeprazole +colloidal pectin bismuth +Amoxicillin +Clarithromycin
  description: Rabeprazole tablets 10mg 2/day+colloidal pectin bismuth 200mg 2/day+Amoxicillin 1g 2/day+Clarithromycin 500mg 2/day
  arm group label: Penicillin negative contral group
  intervention type: Drug
  intervention name: Vonopazan +Minocycline
  description: Vonopazan 20mg 2/day+Minocycline 100mg 2/day
  arm group label: Penicillin positive test group
  intervention type: Drug
  intervention name: Rabeprazole +colloidal pectin bismuth +Metronidazole +Clarithromycin
  description: Rabeprazole tablets 10mg 2/day+colloidal pectin bismuth 200mg 2/day+Metronidazole 0.4g 3/day+Clarithromycin 500mg 2/day
  arm group label: Penicillin positive control group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Shanghai Changzheng Hospital
  investigator full name: Wei-Fen Xie
  investigator title: Head of gastroenterology，Shanghai Changzheng Hospital
  mesh term: Amoxicillin
  mesh term: Metronidazole
  mesh term: Clarithromycin
  mesh term: Minocycline
  mesh term: Rabeprazole
  mesh term: Bismuth
  sharing ipd: No