<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/NCT03829150</url>
  </required_header>
  <id_info>
    <org_study_id>CMRPG8F1421</org_study_id>
    <nct_id>NCT03829150</nct_id>
  </id_info>
  <brief_title>Dexlansoprazole MR-Based Concomitant Quadruple Therapy</brief_title>
  <official_title>Anti-Helicobacter Pylori Therapy With Dexlansoprazole MR-Based Concomitant Quadruple Therapy- A Prospective Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial 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>
      Background:&#xD;
&#xD;
      Recommended proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment&#xD;
      for 7 to14 days is the first choice treatment for H pylori infection. The eradication rate of&#xD;
      the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or less)&#xD;
      recently because the increasing incidence of clarithromycin-resistant strains of H. pylori.&#xD;
      Standard triple therapies should be abandoned in the areas with clarithromycin resistance ≥&#xD;
      20%. The investigators have proven that 7-day Concomitant therapy can achieve a promising&#xD;
      success rate of &gt;90 % in the presence of clarithromycin resistance. However, high dose PPI is&#xD;
      needed with a dosage of twice daily but when a dual delayed release formulation PPI in&#xD;
      capsules for oral administration (Dexlansoprazole MR), a once daily dose may be needed only.&#xD;
      The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules&#xD;
      with different pH-dependent dissolution profiles. It suppresses gastric acid secretion via&#xD;
      inhibition of the proton pump in the gastric parietal cell, which blocks the final step of&#xD;
      acid production. Thus, it improves acid suppression and offer benefits over conventional&#xD;
      single release PPI formulations. by prolonging optimal plasma concentration and create a&#xD;
      favorable condition H. pylori eradication&#xD;
&#xD;
      Aim:&#xD;
&#xD;
      The efficacy of Dexlansoprazole MR-based concomitant quadruple therapy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Recommended proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment&#xD;
      for 7 to14 days is the first choice treatment for H pylori infection. The eradication rate of&#xD;
      the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or less)&#xD;
      recently because the increasing incidence of clarithromycin-resistant strains of H. pylori.&#xD;
      Standard triple therapies should be abandoned in the areas with clarithromycin resistance ≥&#xD;
      20%. The investigators have proven that 7-day Concomitant therapy can achieve a promising&#xD;
      success rate of &gt;90% in the presence of clarithromycin resistance. However, high dose PPI is&#xD;
      needed with a dosage of twice daily but when a dual delayed release formulation PPI in&#xD;
      capsules for oral administration (Dexlansoprazole MR), a once daily dose may be needed only.&#xD;
      The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules&#xD;
      with different pH-dependent dissolution profiles. It suppresses gastric acid secretion via&#xD;
      inhibition of the proton pump in the gastric parietal cell, which blocks the final step of&#xD;
      acid production. Thus, it improves acid suppression and offer benefits over conventional&#xD;
      single release PPI formulations. by prolonging optimal plasma concentration and create a&#xD;
      favorable condition H. pylori eradication&#xD;
&#xD;
      Aim:&#xD;
&#xD;
      The efficacy of Dexlansoprazole MR-based concomitant quadruple therapy&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Two hundred and two consecutive H. pylori-infected participants are randomly assigned to a&#xD;
      7-day Dexlansoprazole MR-based non-bismuth quadruple therapy (Dexlansoprazole MR 60 mg&#xD;
      qd.,clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7&#xD;
      days) or a 7-day lansoprazole-based non-bismuth quadruple therapy (Lansoprazole 30 mg bid. ,&#xD;
      clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days).&#xD;
      Participants are asked to return at the 2nd week to assess drug compliance and adverse&#xD;
      events. Repeated endoscopy with rapid urease test, histological examination is performed at&#xD;
      the 8th week after the end of anti- H. pylori therapy. If participants refuse follow-up&#xD;
      endoscopy, urea breath tests are conducted to assess H. pylori status. The rates of&#xD;
      eradication are analyzed by intention-to-treat and per-protocol analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">April 20, 2019</completion_date>
  <primary_completion_date type="Actual">April 20, 2019</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>The rates of H.pylori eradication</measure>
    <time_frame>8 weeks</time_frame>
    <description>The primary outcome variables were the rates of eradication. Chi-square test with or without Yates correction for continuity and Fisher's exact test were used when appropriate to compare the major outcomes between groups. A P value less than 0.05 was considered statistically significant.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">202</enrollment>
  <condition>Helicobacter Pylori Infection</condition>
  <arm_group>
    <arm_group_label>Dexlansoprazole MR group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dexlansoprazole MR 60 mg qd.,clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>lansoprazole group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lansoprazole 30 mg bid., clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexlan</intervention_name>
    <description>Dexlansoprazole MR 60 mg qd for 7 days</description>
    <arm_group_label>Dexlansoprazole MR group</arm_group_label>
    <arm_group_label>lansoprazole group</arm_group_label>
    <other_name>Dexlansoprazole MR</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amoxicillin</intervention_name>
    <description>Amoxicillin (Amolin) 1 g bid. for 7 days</description>
    <arm_group_label>Dexlansoprazole MR group</arm_group_label>
    <arm_group_label>lansoprazole group</arm_group_label>
    <other_name>Amolin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clarithromycin 500mg</intervention_name>
    <description>clarithromycin (Klaricid) 500 mg bid for 7 days</description>
    <arm_group_label>Dexlansoprazole MR group</arm_group_label>
    <arm_group_label>lansoprazole group</arm_group_label>
    <other_name>Klaricid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Metronidazole</intervention_name>
    <description>Metronidazole (Flagyl) 500 mg bid daily for 7 days</description>
    <arm_group_label>Dexlansoprazole MR group</arm_group_label>
    <arm_group_label>lansoprazole group</arm_group_label>
    <other_name>Flagyl</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        H. pylori-infected outpatients with endoscopically proven peptic ulcer diseases or&#xD;
        gastritis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous H. pylori-eradication therapy&#xD;
&#xD;
          2. ingestion of antibiotics, bismuth, or PPIs within the prior 4 weeks&#xD;
&#xD;
          3. patients with allergic history to the medications used&#xD;
&#xD;
          4. patients with previous gastric surgery&#xD;
&#xD;
          5. the coexistence of serious concomitant illness (for example, decompensated liver&#xD;
             cirrhosis, uremia)&#xD;
&#xD;
          6. pregnant women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seng-Kee Chuah, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaohsiung Chang Gung Memorial Hospital,Taiwan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaohsiung Chang Gung Memorial Hospital,Taiwan</name>
      <address>
        <city>Kaohsiung</city>
        <zip>833</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>May 11, 2019</last_update_submitted>
  <last_update_submitted_qc>May 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Seng-Kee Chuah</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>non-bismuth containing quadruple therapy</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>Dexlansoprazole</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/NCT03829150
org study id: CMRPG8F1421
nct id: NCT03829150
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Background:

      Recommended proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment
      for 7 to14 days is the first choice treatment for H pylori infection. The eradication rate of
      the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or less)
      recently because the increasing incidence of clarithromycin-resistant strains of H. pylori.
      Standard triple therapies should be abandoned in the areas with clarithromycin resistance ≥
      20%. The investigators have proven that 7-day Concomitant therapy can achieve a promising
      success rate of >90 % in the presence of clarithromycin resistance. However, high dose PPI is
      needed with a dosage of twice daily but when a dual delayed release formulation PPI in
      capsules for oral administration (Dexlansoprazole MR), a once daily dose may be needed only.
      The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules
      with different pH-dependent dissolution profiles. It suppresses gastric acid secretion via
      inhibition of the proton pump in the gastric parietal cell, which blocks the final step of
      acid production. Thus, it improves acid suppression and offer benefits over conventional
      single release PPI formulations. by prolonging optimal plasma concentration and create a
      favorable condition H. pylori eradication

      Aim:

      The efficacy of Dexlansoprazole MR-based concomitant quadruple therapy
Background:

      Recommended proton pump inhibitor (PPI)-clarithromycin-amoxicillin or metronidazole treatment
      for 7 to14 days is the first choice treatment for H pylori infection. The eradication rate of
      the standard triple therapy has generally declined to unacceptable levels (i.e., 80% or less)
      recently because the increasing incidence of clarithromycin-resistant strains of H. pylori.
      Standard triple therapies should be abandoned in the areas with clarithromycin resistance ≥
      20%. The investigators have proven that 7-day Concomitant therapy can achieve a promising
      success rate of >90% in the presence of clarithromycin resistance. However, high dose PPI is
      needed with a dosage of twice daily but when a dual delayed release formulation PPI in
      capsules for oral administration (Dexlansoprazole MR), a once daily dose may be needed only.
      The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules
      with different pH-dependent dissolution profiles. It suppresses gastric acid secretion via
      inhibition of the proton pump in the gastric parietal cell, which blocks the final step of
      acid production. Thus, it improves acid suppression and offer benefits over conventional
      single release PPI formulations. by prolonging optimal plasma concentration and create a
      favorable condition H. pylori eradication

      Aim:

      The efficacy of Dexlansoprazole MR-based concomitant quadruple therapy

      Methods:

      Two hundred and two consecutive H. pylori-infected participants are randomly assigned to a
      7-day Dexlansoprazole MR-based non-bismuth quadruple therapy (Dexlansoprazole MR 60 mg
      qd.,clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7
      days) or a 7-day lansoprazole-based non-bismuth quadruple therapy (Lansoprazole 30 mg bid. ,
      clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days).
      Participants are asked to return at the 2nd week to assess drug compliance and adverse
      events. Repeated endoscopy with rapid urease test, histological examination is performed at
      the 8th week after the end of anti- H. pylori therapy. If participants refuse follow-up
      endoscopy, urea breath tests are conducted to assess H. pylori status. The rates of
      eradication are analyzed by intention-to-treat and per-protocol analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The rates of H.pylori eradication
time frame: 8 weeks
description: The primary outcome variables were the rates of eradication. Chi-square test with or without Yates correction for continuity and Fisher's exact test were used when appropriate to compare the major outcomes between groups. A P value less than 0.05 was considered statistically significant.
arm group label: Dexlansoprazole MR group
arm group type: Experimental
description: Dexlansoprazole MR 60 mg qd.,clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days
arm group label: lansoprazole group
arm group type: Experimental
description: Lansoprazole 30 mg bid., clarithromycin 500 mg bid., amoxicillin 1 g bid. and metronidazole 500 mg bid. for 7 days
intervention type: Drug
intervention name: Dexlan
description: Dexlansoprazole MR 60 mg qd for 7 days
arm group label: Dexlansoprazole MR group
arm group label: lansoprazole group
other name: Dexlansoprazole MR
intervention type: Drug
intervention name: Amoxicillin
description: Amoxicillin (Amolin) 1 g bid. for 7 days
arm group label: Dexlansoprazole MR group
arm group label: lansoprazole group
other name: Amolin
intervention type: Drug
intervention name: Clarithromycin 500mg
description: clarithromycin (Klaricid) 500 mg bid for 7 days
arm group label: Dexlansoprazole MR group
arm group label: lansoprazole group
other name: Klaricid
intervention type: Drug
intervention name: Metronidazole
description: Metronidazole (Flagyl) 500 mg bid daily for 7 days
arm group label: Dexlansoprazole MR group
arm group label: lansoprazole group
other name: Flagyl
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Seng-Kee Chuah, MD
role: Principal Investigator
affiliation: Kaohsiung Chang Gung Memorial Hospital,Taiwan
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Seng-Kee Chuah
investigator title: Professor
mesh term: Amoxicillin
mesh term: Metronidazole
mesh term: Clarithromycin
mesh term: Dexlansoprazole