<?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>IRCT201103183836N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-08-13</date_registration>
      <primary_sponsor>Jundishapour Ahvaz Uuniversity of Medical Science</primary_sponsor>
      <public_title>Sequential Therapy versus Quadruple Therapy for H.pylori Eradication in Iran</public_title>
      <acronym>To compare the efficacy of quadruple and sequential therapy in eradication of H.Pylori: in a</acronym>
      <scientific_title>Sequential Therapy versus Quadruple Therapy for H.pylori Eradication in Iran</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-12-02</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>300</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/3963</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>1-2</phase>
      <hc_freetext>Condition 1: Peptic ulcer. Condition 2: Gastritis.</hc_freetext>
      <i_freetext>Intervention 1: Group I (n=150)  will receive quadruple therapy (20 mg omperazole bid, 240 mg bismuth subcitrate bid, 1000 mg tetracycline bid and 500 mg metronidazole bid) for 14 days. Intervention 2: Group II (n=150) will  receive sequential therapy (20 mg omp bid, 1000 mg amoxicillin bid for 5 days, follow by 20 mg omperazole bid, 500mg metronidazole bid, 500mg clarithromycin for the other 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>Abdolrahim Masjedizadeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Azadgan Street-Imam Hospital</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6193673166</zip>
        <telephone>+98 61 1337 6922</telephone>
        <email>masjedi_r@ajums.ac.ir</email>
        <affiliation>Jondishapou Ahvaz University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Eskandar Hajiani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Golstan, Univercity City</address>
        <city>Ahvaz</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6193673166</zip>
        <telephone>+98 61 1222 2922</telephone>
        <email>ehajiani@gmail.com</email>
        <affiliation>Jundishapour Ahvaz Uuniversity of Medical Science</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion:  Patients older than 14 years of age with dyspepsia, gastrointestinal bleeding, history of post prandial fullness and vomiting, undertake  endoscopy.Two  biopsies of the antrum and gastric body will perform. Those patients who have  a positive rapid urease test or histological evidence for H. pylori in the gastric mucosa will enroll.&#13;
Exclusion:Patients with severe comorbidity, such as cirrhosis, kidney failure, severe heart disease, pregnancy, lactation and evidence of malignancy, a previous history of eradication of H. pylori, a history of NSAID use, alcohol consumption and H2 blocker or PPI in the past two weeks or who haVE  receive antibiotics and bismuth subcitrate in the last month will be excluded.</inclusion_criteria>
      <agemin>14 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K25-K26</hc_code>
      <hc_code>K29</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Gastric ulcer -Duodenal ulcer -  erosion (acute) of stomach  -erosion (acute) of duodenum</hc_keyword>
      <hc_keyword>Chronic gastritis, unspecified , Acute (erosive) gastritis with haemorrhage</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>Group I (n=150)  will receive quadruple therapy (20 mg omperazole bid, 240 mg bismuth subcitrate bid, 1000 mg tetracycline bid and 500 mg metronidazole bid) for 14 days</i_keyword>
      <i_keyword>Group II (n=150) will  receive sequential therapy (20 mg omp bid, 1000 mg amoxicillin bid for 5 days, follow by 20 mg omperazole bid, 500mg metronidazole bid, 500mg clarithromycin for the other 5 days)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Eeradication helicobacter pylori. Timepoint: Four weeks. Method of measurement: Urea breath test.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Side effect. Timepoint: Three days. Method of measurement: Good, intermediate and poor assessed by physician.</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>Jundishapour Ahvaz Uuniversity of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-06-20</approval_date>
        <contact_name>Jundishapour Ahvaz University of Medical Science</contact_name>
        <contact_address>Golstan highway Ahvaz  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
