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Trial record 84 of 397 for:    CLARITHROMYCIN

Aizthromycin or Clarithromycin in H-pylori Eradication Regimen (H-pylori)

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ClinicalTrials.gov Identifier: NCT01667692
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : August 17, 2012
Sponsor:
Information provided by (Responsible Party):
Behnam Baghianimoghadam, Shahid Sadoughi University of Medical Sciences and Health Services

Tracking Information
First Submitted Date  ICMJE August 12, 2012
First Posted Date  ICMJE August 17, 2012
Last Update Posted Date August 17, 2012
Study Start Date  ICMJE March 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2012)
H-pylori cinfirmation [ Time Frame: 1-3 months before study ]
confirmation is by endoscopy and biopsy
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2012)
  • h-pylori eradication confirmation [ Time Frame: two months after completion of 14 days standard treatment ]
    confirmation of eradication was by endoscopy and biopsy
  • side effect of study srugs [ Time Frame: during 14 days standard treatment ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aizthromycin or Clarithromycin in H-pylori Eradication Regimen
Official Title  ICMJE Comparison of Azithromycin or Clarithromycin in 3drugs Protocol of H-pylori Eradication Regimen
Brief Summary The Aim of this study is comparison between two regimens containing clarithromycinand azithromycin.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Peptic Ulcer
  • Dyspepsia
  • H-pylori
Intervention  ICMJE
  • Drug: azithromycin
    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.
    Other Name: (Zithromax, Azithrocin
  • Drug: clarithmycin
    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.
    Other Name: Crixan, Claritt, Clarac, Biaxin, Klaricid, Klacid...
Study Arms  ICMJE
  • Experimental: azithromycin
    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.
    Intervention: Drug: azithromycin
  • Experimental: clarithromycin
    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: Drug: clarithmycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2012)
78
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients with peptic ulcer due to H-pylori confirmed endoscopy and biopsy

Exclusion Criteria:

  • patients who got H-pylori eradication treatment previously
  • patients who used study drugs during 3months before study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01667692
Other Study ID Numbers  ICMJE ssu.hakimi-89027
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Behnam Baghianimoghadam, Shahid Sadoughi University of Medical Sciences and Health Services
Study Sponsor  ICMJE Shahid Sadoughi University of Medical Sciences and Health Services
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shahid Sadoughi University of Medical Sciences and Health Services
Verification Date August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP