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

August 15, 2012 updated by: Behnam Baghianimoghadam, Shahid Sadoughi University of Medical Sciences and Health Services

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

78

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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 Names:
  • (Zithromax, Azithrocin
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
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 Names:
  • Crixan, Claritt, Clarac, Biaxin, Klaricid, Klacid...

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
H-pylori cinfirmation
Time Frame: 1-3 months before study
confirmation is by endoscopy and biopsy
1-3 months before study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
h-pylori eradication confirmation
Time Frame: two months after completion of 14 days standard treatment
confirmation of eradication was by endoscopy and biopsy
two months after completion of 14 days standard treatment
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.
during 14 days standard treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Sadoughi University of Medical Sciences and Health Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

August 12, 2012

First Submitted That Met QC Criteria

August 15, 2012

First Posted (Estimate)

August 17, 2012

Study Record Updates

Last Update Posted (Estimate)

August 17, 2012

Last Update Submitted That Met QC Criteria

August 15, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ssu.hakimi-89027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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