<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/NCT03021590</url>
  </required_header>
  <id_info>
    <org_study_id>G5-17</org_study_id>
    <nct_id>NCT03021590</nct_id>
  </id_info>
  <brief_title>Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori</brief_title>
  <official_title>Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Damascus Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Damascus 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>
      Comparison Efficacy of 14-day Concomitant therapy between levofloxacin and Clarithromycin on&#xD;
      the Eradication of Helicobacter Pylori in Syrian population&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No Participants Enrolled&#xD;
  </why_stopped>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Anticipated">January 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <phase>Phase 4</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Helicobacter pylori Eradication rate</measure>
    <time_frame>6 weeks after eradication therapy</time_frame>
    <description>Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Helicobacter Pylori Gastrointestinal Tract Infection</condition>
  <arm_group>
    <arm_group_label>Clarithromycin :Concomitant Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Amoxicillin 1000 mg Tablets, Clarithromycin 500 mg Tablets , Tinidazole 500 mg Tablets and Esomeprazole 20 mg Capsule each every 12 hours for 14 days all by mouth</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Levofloxacin :Concomitant Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Levofloxacin 500 mg Tablets Amoxicillin 1000 mg Tablets,Tinidazole 500 mg Tablets and Esomeprazole 20 mg each every 12 hours for 14 days all by mouth</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clarithromycin 500Mg Oral Tablet</intervention_name>
    <description>Amoxicillin 1000 mg Tablets every 12 hours , Esomeprazole 20 mg Capsule days all&#xD;
,Clarithromycin 500 mg Tablets and Tinidazole 500 mg Tablets every 12 hours for 14 days all by mouth</description>
    <arm_group_label>Clarithromycin :Concomitant Therapy</arm_group_label>
    <other_name>Esomeprazole 40Mg Capsule</other_name>
    <other_name>Amoxicillin 1000Mg Capsule</other_name>
    <other_name>Tinidazole 500Mg Tablet</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levofloxacin 500Mg Oral Tablet</intervention_name>
    <description>Amoxicillin 1000 mg Tablets , Esomeprazole 20 mg Capsule,Levofloxacin 500 mg Tablets and Tinidazole 500 mg Tablets all every 12 hours for 14 days all by mouth</description>
    <arm_group_label>Levofloxacin :Concomitant Therapy</arm_group_label>
    <other_name>Esomeprazole 40Mg Capsule</other_name>
    <other_name>Amoxicillin 1000Mg Capsule</other_name>
    <other_name>Tinidazole 500Mg Tablet</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any&#xD;
        of following three methods: I-Positive rapid urease test (CLOtest). II-Histologic evidence&#xD;
        of H. pylori by modified Giemsa staining. III-Positive 13C-urea breath test. without prior&#xD;
        eradication therapy and are willing to receive therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children and teenagers aged less than 18 years.&#xD;
&#xD;
          -  Previous eradication treatment for H. pylori.&#xD;
&#xD;
          -  Patients who took any drug, which could influence the study results such as proton&#xD;
             pump inhibitor, H2 blocker, mucosal protective agent and antibiotics.&#xD;
&#xD;
          -  History of gastrectomy.&#xD;
&#xD;
          -  Gastric malignancy, including adenocarcinoma and lymphoma,&#xD;
&#xD;
          -  Previous allergic reaction to antibiotics (Amoxicillin, Tinidazole , Levofloxacin) and&#xD;
             prompt pump inhibitors (Es-omeprazole).&#xD;
&#xD;
          -  Contraindication to treatment drugs.&#xD;
&#xD;
          -  Pregnant or lactating women.&#xD;
&#xD;
          -  Severe concurrent disease. Liver cirrhosis. Chronic kidney disease.&#xD;
&#xD;
          -  Patients who cannot give informed consent by himself or herself.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Damascus Hospital</name>
      <address>
        <city>Damascus</city>
        <zip>+963</zip>
        <country>Syrian Arab Republic</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Syrian Arab Republic</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Helicobacter pylori</keyword>
  <keyword>Helicobacter Infections</keyword>
  <keyword>Proton Pump Inhibitors</keyword>
  <keyword>sequential therapy</keyword>
  <keyword>Clarithromycin</keyword>
  <keyword>Tinidazole</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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>Clarithromycin</mesh_term>
    <mesh_term>Levofloxacin</mesh_term>
    <mesh_term>Tinidazole</mesh_term>
    <mesh_term>Esomeprazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03021590
org study id: G5-17
nct id: NCT03021590
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Comparison Efficacy of 14-day Concomitant therapy between levofloxacin and Clarithromycin on
      the Eradication of Helicobacter Pylori in Syrian population
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Helicobacter pylori Eradication rate
time frame: 6 weeks after eradication therapy
description: Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis
arm group label: Clarithromycin :Concomitant Therapy
arm group type: Experimental
description: Amoxicillin 1000 mg Tablets, Clarithromycin 500 mg Tablets , Tinidazole 500 mg Tablets and Esomeprazole 20 mg Capsule each every 12 hours for 14 days all by mouth
arm group label: Levofloxacin :Concomitant Therapy
arm group type: Active Comparator
description: Levofloxacin 500 mg Tablets Amoxicillin 1000 mg Tablets,Tinidazole 500 mg Tablets and Esomeprazole 20 mg each every 12 hours for 14 days all by mouth
intervention type: Drug
intervention name: Clarithromycin 500Mg Oral Tablet
description: Amoxicillin 1000 mg Tablets every 12 hours , Esomeprazole 20 mg Capsule days all
,Clarithromycin 500 mg Tablets and Tinidazole 500 mg Tablets every 12 hours for 14 days all by mouth
arm group label: Clarithromycin :Concomitant Therapy
other name: Esomeprazole 40Mg Capsule
other name: Amoxicillin 1000Mg Capsule
other name: Tinidazole 500Mg Tablet
intervention type: Drug
intervention name: Levofloxacin 500Mg Oral Tablet
description: Amoxicillin 1000 mg Tablets , Esomeprazole 20 mg Capsule,Levofloxacin 500 mg Tablets and Tinidazole 500 mg Tablets all every 12 hours for 14 days all by mouth
arm group label: Levofloxacin :Concomitant Therapy
other name: Esomeprazole 40Mg Capsule
other name: Amoxicillin 1000Mg Capsule
other name: Tinidazole 500Mg Tablet
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Syrian Arab Republic
responsible party type: Sponsor
mesh term: Infections
mesh term: Amoxicillin
mesh term: Clarithromycin
mesh term: Levofloxacin
mesh term: Tinidazole
mesh term: Esomeprazole
sharing ipd: Undecided