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

Primary Purpose

Peptic Ulcer, Dyspepsia, H-pylori

Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
azithromycin
clarithmycin
Sponsored by
Shahid Sadoughi University of Medical Sciences and Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peptic Ulcer focused on measuring H-pylori, eradication, azithromycin, clarithromycin

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Behnam Baghianimoghadam

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

azithromycin

clarithromycin

Arm 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.

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.

Outcomes

Primary Outcome Measures

H-pylori cinfirmation
confirmation is by endoscopy and biopsy

Secondary Outcome Measures

h-pylori eradication confirmation
confirmation of eradication was by endoscopy and biopsy
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.

Full Information

First Posted
August 12, 2012
Last Updated
August 15, 2012
Sponsor
Shahid Sadoughi University of Medical Sciences and Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT01667692
Brief Title
Aizthromycin or Clarithromycin in H-pylori Eradication Regimen
Acronym
H-pylori
Official Title
Comparison of Azithromycin or Clarithromycin in 3drugs Protocol of H-pylori Eradication Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Sadoughi University of Medical Sciences and Health Services

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer, Dyspepsia, H-pylori
Keywords
H-pylori, eradication, azithromycin, clarithromycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
azithromycin
Arm Type
Experimental
Arm 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 Title
clarithromycin
Arm Type
Experimental
Arm 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(s)
azithromycin
Other Intervention Name(s)
(Zithromax, Azithrocin
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
clarithmycin
Other Intervention Name(s)
Crixan, Claritt, Clarac, Biaxin, Klaricid, Klacid...
Intervention 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.
Primary Outcome Measure Information:
Title
H-pylori cinfirmation
Description
confirmation is by endoscopy and biopsy
Time Frame
1-3 months before study
Secondary Outcome Measure Information:
Title
h-pylori eradication confirmation
Description
confirmation of eradication was by endoscopy and biopsy
Time Frame
two months after completion of 14 days standard treatment
Title
side effect of study srugs
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.
Time Frame
during 14 days standard treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Behnam Baghianimoghadam
City
Yazd
ZIP/Postal Code
8916863411
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Aizthromycin or Clarithromycin in H-pylori Eradication Regimen

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