<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/NCT01667692</url>
  </required_header>
  <id_info>
    <org_study_id>ssu.hakimi-89027</org_study_id>
    <nct_id>NCT01667692</nct_id>
  </id_info>
  <brief_title>Aizthromycin or Clarithromycin in H-pylori Eradication Regimen</brief_title>
  <acronym>H-pylori</acronym>
  <official_title>Comparison of Azithromycin or Clarithromycin in 3drugs Protocol of H-pylori Eradication Regimen</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shahid Sadoughi University of Medical Sciences and Health Services</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shahid Sadoughi University of Medical Sciences and Health Services</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Aim of this study is comparison between two regimens containing clarithromycinand&#xD;
      azithromycin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eradication of helicobacter pylori is important for treatment of GU but ideal regimen is not&#xD;
      available.&#xD;
&#xD;
      HP is resistant to metronidazole and clarithromycin, thus clarithromycin is expensive and it&#xD;
      is not available in underdevelopment countries.&#xD;
&#xD;
      There are different articles about replacement clarithromycin with azithromycin as a method&#xD;
      of eradication of HP that is decreases length of therapy and increases, effectiveness of&#xD;
      drugs and decreases resistance of drugs.&#xD;
&#xD;
      The Aim of this study is comparison between two regimens containing clarithromycinand&#xD;
      azithromycin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2011</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">November 2011</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>H-pylori cinfirmation</measure>
    <time_frame>1-3 months before study</time_frame>
    <description>confirmation is by endoscopy and biopsy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>h-pylori eradication confirmation</measure>
    <time_frame>two months after completion of 14 days standard treatment</time_frame>
    <description>confirmation of eradication was by endoscopy and biopsy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>side effect of study srugs</measure>
    <time_frame>during 14 days standard treatment</time_frame>
    <description>it was assessed by researcher and self report of patients. variables like nausea, vomiting and diarrhea. the prevalence of each treatment related complain was registered by taking history from patients.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Peptic Ulcer</condition>
  <condition>Dyspepsia</condition>
  <condition>H-pylori</condition>
  <arm_group>
    <arm_group_label>azithromycin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Azithromycin (Zithromax, Azithrocin ) is an azalide, a subclass of macrolide antibiotics. Azithromycin is one of the world's best-selling antibiotics. It is derived from erythromycin, with a methyl-substituted nitrogen atom incorporated into the lactone ring, thus making the lactone ring 15-membered.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>clarithromycin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clarithromycin is a macrolide antibiotic used to treat pharyngitis, tonsillitis, acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, pneumonia (especially atypical pneumonias associated with Chlamydophila pneumoniae), skin and skin structure infections. In addition, it is sometimes used to treat legionellosis, Helicobacter pylori, and lyme disease.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>azithromycin</intervention_name>
    <description>Azithromycin (Zithromax, Azithrocin ) is an azalide, a subclass of macrolide antibiotics. Azithromycin is one of the world's best-selling antibiotics.[1] It is derived from erythromycin, with a methyl-substituted nitrogen atom incorporated into the lactone ring, thus making the lactone ring 15-membered.</description>
    <arm_group_label>azithromycin</arm_group_label>
    <other_name>(Zithromax, Azithrocin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>clarithmycin</intervention_name>
    <description>Clarithromycin is a macrolide antibiotic used to treat pharyngitis, tonsillitis, acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, pneumonia (especially atypical pneumonias associated with Chlamydophila pneumoniae), skin and skin structure infections. In addition, it is sometimes used to treat legionellosis, Helicobacter pylori, and lyme disease.</description>
    <arm_group_label>clarithromycin</arm_group_label>
    <other_name>Crixan, Claritt, Clarac, Biaxin, Klaricid, Klacid...</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with peptic ulcer due to H-pylori confirmed endoscopy and biopsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who got H-pylori eradication treatment previously&#xD;
&#xD;
          -  patients who used study drugs during 3months before study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Behnam Baghianimoghadam</name>
      <address>
        <city>Yazd</city>
        <zip>8916863411</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 12, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>August 15, 2012</last_update_submitted>
  <last_update_submitted_qc>August 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shahid Sadoughi University of Medical Sciences and Health Services</investigator_affiliation>
    <investigator_full_name>Behnam Baghianimoghadam</investigator_full_name>
    <investigator_title>research consultant</investigator_title>
  </responsible_party>
  <keyword>H-pylori</keyword>
  <keyword>eradication</keyword>
  <keyword>azithromycin</keyword>
  <keyword>clarithromycin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peptic Ulcer</mesh_term>
    <mesh_term>Dyspepsia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azithromycin</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/NCT01667692
org study id: ssu.hakimi-89027
nct id: NCT01667692
lead sponsor: 
has dmc: No
The Aim of this study is comparison between two regimens containing clarithromycinand
      azithromycin.
Eradication of helicobacter pylori is important for treatment of GU but ideal regimen is not
      available.

      HP is resistant to metronidazole and clarithromycin, thus clarithromycin is expensive and it
      is not available in underdevelopment countries.

      There are different articles about replacement clarithromycin with azithromycin as a method
      of eradication of HP that is decreases length of therapy and increases, effectiveness of
      drugs and decreases resistance of drugs.

      The Aim of this study is comparison between two regimens containing clarithromycinand
      azithromycin.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: H-pylori cinfirmation
time frame: 1-3 months before study
description: confirmation is by endoscopy and biopsy
measure: h-pylori eradication confirmation
time frame: two months after completion of 14 days standard treatment
description: confirmation of eradication was by endoscopy and biopsy
measure: side effect of study srugs
time frame: during 14 days standard treatment
description: it was assessed by researcher and self report of patients. variables like nausea, vomiting and diarrhea. the prevalence of each treatment related complain was registered by taking history from patients.
arm group label: azithromycin
arm group type: Experimental
description: Azithromycin (Zithromax, Azithrocin ) is an azalide, a subclass of macrolide antibiotics. Azithromycin is one of the world's best-selling antibiotics. It is derived from erythromycin, with a methyl-substituted nitrogen atom incorporated into the lactone ring, thus making the lactone ring 15-membered.
arm group label: clarithromycin
arm group type: Experimental
description: Clarithromycin is a macrolide antibiotic used to treat pharyngitis, tonsillitis, acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, pneumonia (especially atypical pneumonias associated with Chlamydophila pneumoniae), skin and skin structure infections. In addition, it is sometimes used to treat legionellosis, Helicobacter pylori, and lyme disease.
intervention type: Drug
intervention name: azithromycin
description: Azithromycin (Zithromax, Azithrocin ) is an azalide, a subclass of macrolide antibiotics. Azithromycin is one of the world's best-selling antibiotics.[1] It is derived from erythromycin, with a methyl-substituted nitrogen atom incorporated into the lactone ring, thus making the lactone ring 15-membered.
arm group label: azithromycin
other name: (Zithromax, Azithrocin
intervention type: Drug
intervention name: clarithmycin
description: Clarithromycin is a macrolide antibiotic used to treat pharyngitis, tonsillitis, acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, pneumonia (especially atypical pneumonias associated with Chlamydophila pneumoniae), skin and skin structure infections. In addition, it is sometimes used to treat legionellosis, Helicobacter pylori, and lyme disease.
arm group label: clarithromycin
other name: Crixan, Claritt, Clarac, Biaxin, Klaricid, Klacid...
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Shahid Sadoughi University of Medical Sciences and Health Services
investigator full name: Behnam Baghianimoghadam
investigator title: research consultant
mesh term: Peptic Ulcer
mesh term: Dyspepsia
mesh term: Azithromycin