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CompletedNCT01667692H-pyloriUpdated Aug 17, 2012

Aizthromycin or Clarithromycin in H-pylori Eradication Regimen

A Phase 4 interventional study of azithromycin and clarithmycin in Peptic Ulcer, Dyspepsia and H-pylori, sponsored by Shahid Sadoughi University of Medical Sciences and Health Services. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-08-17.

Sponsored by Shahid Sadoughi University of Medical Sciences and Health Services · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
01

Study summary

The Aim of this study is comparison between two regimens containing clarithromycinand azithromycin.

Read the 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.

02

Conditions studied

  • Peptic Ulcer
  • Dyspepsia
  • H-pylori

Keywords

  • H-pylori
  • eradication
  • azithromycin
  • clarithromycin
03

Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients who got H-pylori eradication treatment previously
  • patients who used study drugs during 3months before study
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
78 participants (actual)

Study arms

  • 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.

    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.

    Drug: clarithmycin

Interventions

  • Drugazithromycin

    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.

    Also known as: (Zithromax, Azithrocin

  • Drugclarithmycin

    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.

    Also known as: Crixan, Claritt, Clarac, Biaxin, Klaricid, Klacid...

05

What researchers measure

Primary outcomes

  1. H-pylori cinfirmation

    confirmation is by endoscopy and biopsy

    Time frame: 1-3 months before study

Secondary outcomes

  1. h-pylori eradication confirmation

    confirmation of eradication was by endoscopy and biopsy

    Time frame: two months after completion of 14 days standard treatment

  2. side effect of study srugs

    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.

    Time frame: during 14 days standard treatment

06

Study locations

1 site
  • Behnam Baghianimoghadam
    Yazd, 8916863411, Iran, Islamic Republic of
07

Registry details

Key details

Study ID
NCT01667692
Lead sponsor
Shahid Sadoughi University of Medical Sciences and Health Services
Responsible party
Behnam Baghianimoghadam (research consultant, Shahid Sadoughi University of Medical Sciences and Health Services) — Principal investigator
First posted
Aug 17, 2012
Start date
Mar 2011
Primary completion
Nov 2011
Completion
Mar 2012
Last update
Aug 17, 2012

Oversight

Data monitoring committee
No
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