Aizthromycin or Clarithromycin in H-pylori Eradication Regimen

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Behnam Baghianimoghadam, Shahid Sadoughi University of Medical Sciences and Health Services
ClinicalTrials.gov Identifier:
NCT01667692
First received: August 12, 2012
Last updated: August 15, 2012
Last verified: August 2012

August 12, 2012
August 15, 2012
March 2011
November 2011   (final data collection date for primary outcome measure)
H-pylori cinfirmation [ Time Frame: 1-3 months before study ] [ Designated as safety issue: Yes ]
confirmation is by endoscopy and biopsy
Same as current
Complete list of historical versions of study NCT01667692 on ClinicalTrials.gov Archive Site
  • h-pylori eradication confirmation [ Time Frame: two months after completion of 14 days standard treatment ] [ Designated as safety issue: Yes ]
    confirmation of eradication was by endoscopy and biopsy
  • side effect of study srugs [ Time Frame: during 14 days standard treatment ] [ Designated as safety issue: Yes ]
    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.
Same as current
Not Provided
Not Provided
 
Aizthromycin or Clarithromycin in H-pylori Eradication Regimen
Comparison of Azithromycin or Clarithromycin in 3drugs Protocol of H-pylori Eradication Regimen

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Peptic Ulcer
  • Dyspepsia
  • H-pylori
  • 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...
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
March 2012
November 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01667692
ssu.hakimi-89027
No
Behnam Baghianimoghadam, Shahid Sadoughi University of Medical Sciences and Health Services
Shahid Sadoughi University of Medical Sciences and Health Services
Not Provided
Not Provided
Shahid Sadoughi University of Medical Sciences and Health Services
August 2012

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