<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/NCT01723059</url>
  </required_header>
  <id_info>
    <org_study_id>11-060</org_study_id>
    <nct_id>NCT01723059</nct_id>
  </id_info>
  <brief_title>Standard Triple Therapy vs Sequential Therapy in Treatment of H Pylori Infection</brief_title>
  <official_title>Conventional Therapy vs Sequential Therapy for the Treatment of Helicobacter Pylori Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dallas VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Otsuka Pharmaceutical Development &amp; Commercialization, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Dallas VA Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Traditionally, H pylori infection has been treated with conventional triple therapy. This&#xD;
      includes amoxicillin, clarithromycin and a proton pump inhibitor all given daily for 10-14&#xD;
      days. In Europe, the guidelines now advocate treatment of H pylori with sequential therapy&#xD;
      which is 5 days of amoxicillin therapy with proton pump inhibitor followed by 5 days of&#xD;
      clarithromycin, metronidazole, and proton pump inhibitor with better response rates. We&#xD;
      hypothesize that H. pylori resistance pattern and treatment response rates observed in Europe&#xD;
      will not be predictive of resistance patterns and response rates in the United States.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2012</start_date>
  <completion_date type="Anticipated">January 2013</completion_date>
  <primary_completion_date type="Anticipated">January 2013</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Helicobacter pylori eradication</measure>
    <time_frame>4 weeks after completion of treatment</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">184</enrollment>
  <condition>Helicobacter Infection</condition>
  <arm_group>
    <arm_group_label>Standard triple therapy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Gold standard for management of H pylori is amoxicillin 1 gm twice daily, clarithromycin 500 mg twice daily, and omeprazole 20 mg twice daily for 10 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sequential Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Amoxicillin 1 gm twice daily and omeprazole 20 mg twice daily for 5 days followed by metronidazole 500 mg twice daily, clarithromycin 500 mg twice daily, and omeprazole 20 mg twice daily for 5 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard Triple Therapy</intervention_name>
    <description>for 10 days</description>
    <arm_group_label>Standard triple therapy</arm_group_label>
    <other_name>Amoxicillin 1000 mg orally twice daily</other_name>
    <other_name>Omeprazole 20 mg orally twice daily</other_name>
    <other_name>Clarithromycin 500 mg orally twice daily</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sequential Therapy</intervention_name>
    <description>total 10 days</description>
    <arm_group_label>Sequential Therapy</arm_group_label>
    <other_name>Amoxicillin 1000 mg orally twice daily for 5 days</other_name>
    <other_name>Omeprazole 20 mg orally twice daily for 5 days</other_name>
    <other_name>Then</other_name>
    <other_name>Clarithromycin 500 mg orally twice daily for 5 days</other_name>
    <other_name>Metronidazole 500 mg orally twice daily for 5 days</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subject has signed informed consent Subject is an adult older than 18 yrs old and requires&#xD;
        an upper endoscopic evaluation If female and of child bearing potential, subject has a&#xD;
        negative pregnancy test and is not nursing.&#xD;
&#xD;
        Patient has not received prior treatment for H pylori Subject is able to understand and&#xD;
        comply with study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Recent use (within 4 weeks) of any of the medications used in the treatment of H&#xD;
        pylori(Amoxicillin, Clarithromycin, Metronidazole) Subject undergoing endoscopy for acute&#xD;
        gastrointestinal bleeding Subject has an allergy to any of the medications used in the&#xD;
        treatment of H pylori Subject has a history of esophageal or gastric carcinoma including&#xD;
        lymphoma Subject has esophageal varices or undergoing endoscopy for esophageal banding&#xD;
        Subject is taking warfarin or clopidogrel Subject has coagulopathy that precludes safe&#xD;
        biopsy of the biopsy areas Subject has comorbidity that precludes safe participation in the&#xD;
        study Subject is a pregnant female Subject has a history of H. pylori infection. Patient is&#xD;
        already enrolled in GI Study. History of UGI surgery other than Nissen Fundoplication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Byron Cryer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gastroenterologist, MD VA</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Robert Genta, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Pathologist, MD</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elizabeth Coss, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Gastroenterology Fellow, MD</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Byron Cryer, MD</last_name>
    <phone>214-857-1603</phone>
    <email>byron.cryer@utsouthwestern.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Elizabeth Coss, MD</last_name>
    <phone>817-896-7030</phone>
    <email>elizabeth.coss@phhs.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Dallas VAMC</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Byron Cryer, MD</last_name>
      <email>byron.cryer@utsouthwestern.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 5, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>November 5, 2012</last_update_submitted>
  <last_update_submitted_qc>November 5, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 7, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dallas VA Medical Center</investigator_affiliation>
    <investigator_full_name>Byron Cryer</investigator_full_name>
    <investigator_title>Staff Gastroenterologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Helicobacter Infections</mesh_term>
  </condition_browse>
  <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>Omeprazole</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/NCT01723059
org study id: 11-060
nct id: NCT01723059
lead sponsor: 
collaborator: 
has dmc: No
Traditionally, H pylori infection has been treated with conventional triple therapy. This
      includes amoxicillin, clarithromycin and a proton pump inhibitor all given daily for 10-14
      days. In Europe, the guidelines now advocate treatment of H pylori with sequential therapy
      which is 5 days of amoxicillin therapy with proton pump inhibitor followed by 5 days of
      clarithromycin, metronidazole, and proton pump inhibitor with better response rates. We
      hypothesize that H. pylori resistance pattern and treatment response rates observed in Europe
      will not be predictive of resistance patterns and response rates in the United States.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Helicobacter pylori eradication
time frame: 4 weeks after completion of treatment
arm group label: Standard triple therapy
arm group type: Other
description: Gold standard for management of H pylori is amoxicillin 1 gm twice daily, clarithromycin 500 mg twice daily, and omeprazole 20 mg twice daily for 10 days.
arm group label: Sequential Therapy
arm group type: Active Comparator
description: Amoxicillin 1 gm twice daily and omeprazole 20 mg twice daily for 5 days followed by metronidazole 500 mg twice daily, clarithromycin 500 mg twice daily, and omeprazole 20 mg twice daily for 5 days.
intervention type: Drug
intervention name: Standard Triple Therapy
description: for 10 days
arm group label: Standard triple therapy
other name: Amoxicillin 1000 mg orally twice daily
other name: Omeprazole 20 mg orally twice daily
other name: Clarithromycin 500 mg orally twice daily
intervention type: Drug
intervention name: Sequential Therapy
description: total 10 days
arm group label: Sequential Therapy
other name: Amoxicillin 1000 mg orally twice daily for 5 days
other name: Omeprazole 20 mg orally twice daily for 5 days
other name: Then
other name: Clarithromycin 500 mg orally twice daily for 5 days
other name: Metronidazole 500 mg orally twice daily for 5 days
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Byron Cryer, MD
role: Principal Investigator
affiliation: Gastroenterologist, MD VA
last name: Robert Genta, MD
role: Study Chair
affiliation: Pathologist, MD
last name: Elizabeth Coss, MD
role: Study Chair
affiliation: Gastroenterology Fellow, MD
last name: Byron Cryer, MD
phone: 214-857-1603
email: byron.cryer@utsouthwestern.edu
last name: Elizabeth Coss, MD
phone: 817-896-7030
email: elizabeth.coss@phhs.org
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dallas VA Medical Center
investigator full name: Byron Cryer
investigator title: Staff Gastroenterologist
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Helicobacter Infections
mesh term: Amoxicillin
mesh term: Metronidazole
mesh term: Clarithromycin
mesh term: Omeprazole