<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT201110312499N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-12-02</date_registration>
      <primary_sponsor>Vice Chancellor For Research, Mazandaran University of Medical Sciences</primary_sponsor>
      <public_title>comparison of sequential-concomitant hybrid to sequential therapy in h.pylori eradication rate</public_title>
      <acronym>sequential-concomitant (hybrid)</acronym>
      <scientific_title>hybrid therapy in H.pylori</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>296</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/2231</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>PUD(H.PYLORI ERADICATION REGIMEN).</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: pantoprazole 40mg (BD) + Amoxicillin 1g (BD) + Clarithromycin 500mg (BD) and Tinidazole 500mg (BD) during the first  2 weeks. Intervention 2: Control group: pantoprazole 40mg (BD) for 10 days + Amoxicillin 1g (BD) just during the first 5 days + Clarithromycin 500mg (BD) and Tinidazole  500mg (BD) just during the second 5 days.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Hafez Tirgar Fakheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital, Razi street,Internal Medicine Department, Sari    Mazandaran  Iran, Islamic Republic Of    00981512261700  00989111521404  00981512264044</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>00981512261700  00989111521404  00981512264044</telephone>
        <email>Hfakheri@mazums.ac.ir  fakheri42@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Hafez Tirgar Fakheri</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Imam Khomeini Hospital, Razi street, Internal Medicine Department, Sari ,Mazandaran</address>
        <city>Sari</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>00981512261700  00989111521404  00981512264044</telephone>
        <email>Hfakheri@mazums.ac.ir fakher42@yahoo.com</email>
        <affiliation>Mazandaran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: age more than 18 years and less than 80 years with duodenal or gastric ulcers; duodenal or gastric erosions and helicobacter pylori positivity.   Exclusion criteria: Previous history of receiving any H.pylori eradication regimen, Taking H2 blocker, proton pump inhibitor, Bismuth or Antibiotics during the 2 weeks prior to the study, Taking anticoagulants, ketoconazole or corticosteroids, History of gastric or esophageal surgery, Severe cardiovascular, pulmonary or endocrine disease, Renal failure, Hepatic diseases, Malignancies, Alcoholism, Pregnancy or breast feeding</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K25.9,K26.</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>GASTRIC ULCER,DUODENAL ULCER,PEPTIC ULCER DISEASE, GASRTRODUODENITIS</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: pantoprazole 40mg (BD) + Amoxicillin 1g (BD) + Clarithromycin 500mg (BD) and Tinidazole 500mg (BD) during the first  2 weeks</i_keyword>
      <i_keyword>Control group: pantoprazole 40mg (BD) for 10 days + Amoxicillin 1g (BD) just during the first 5 days + Clarithromycin 500mg (BD) and Tinidazole  500mg (BD) just during the second 5 days</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Helicobacter pylori eradication rate. Timepoint: 2 months after the completion of treatment course. Method of measurement: urease breath test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side effects of drugs. Timepoint: daily recording during and after the treatment course. Method of measurement: classifying as mild, moderate or severe side effects.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Vice Chancellor For Research, Mazandaran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-08-07</approval_date>
        <contact_name>Mazandaran University of Medical Sciences</contact_name>
        <contact_address>Imam Khomeini Hospital, Sari, Razi street  Sari  Mazandaran sari  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
