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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
  Purpose

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


Condition Intervention Phase
Peptic Ulcer
Dyspepsia
H-pylori
Drug: azithromycin
Drug: clarithmycin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Azithromycin or Clarithromycin in 3drugs Protocol of H-pylori Eradication Regimen

Resource links provided by NLM:


Further study details as provided by Shahid Sadoughi University of Medical Sciences and Health Services:

Primary Outcome Measures:
  • H-pylori cinfirmation [ Time Frame: 1-3 months before study ] [ Designated as safety issue: Yes ]
    confirmation is by endoscopy and biopsy


Secondary Outcome Measures:
  • 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.


Enrollment: 78
Study Start Date: March 2011
Study Completion Date: March 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: (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 Name: Crixan, Claritt, Clarac, Biaxin, Klaricid, Klacid...

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667692

Locations
Iran, Islamic Republic of
Behnam Baghianimoghadam
Yazd, Iran, Islamic Republic of, 8916863411
Sponsors and Collaborators
Shahid Sadoughi University of Medical Sciences and Health Services
  More Information

No publications provided

Responsible Party: Behnam Baghianimoghadam, research consultant, Shahid Sadoughi University of Medical Sciences and Health Services
ClinicalTrials.gov Identifier: NCT01667692     History of Changes
Other Study ID Numbers: ssu.hakimi-89027
Study First Received: August 12, 2012
Last Updated: August 15, 2012
Health Authority: Iran: Ministry of health and medical education

Keywords provided by Shahid Sadoughi University of Medical Sciences and Health Services:
H-pylori
eradication
azithromycin
clarithromycin

Additional relevant MeSH terms:
Peptic Ulcer
Digestive System Diseases
Duodenal Diseases
Gastrointestinal Diseases
Intestinal Diseases
Stomach Diseases
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014