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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01667692
First Posted: August 17, 2012
Last Update Posted: August 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Behnam Baghianimoghadam, Shahid Sadoughi University of Medical Sciences and Health Services
  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
Intervention Model: Parallel Assignment
Masking: Double (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 Behnam Baghianimoghadam, Shahid Sadoughi University of Medical Sciences and Health Services:

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


Secondary Outcome Measures:
  • h-pylori eradication confirmation [ Time Frame: two months after completion of 14 days standard treatment ]
    confirmation of eradication was by endoscopy and biopsy

  • 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.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 12, 2012
First Posted: August 17, 2012
Last Update Posted: August 17, 2012
Last Verified: August 2012

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

Additional relevant MeSH terms:
Dyspepsia
Peptic Ulcer
Signs and Symptoms, Digestive
Signs and Symptoms
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Anti-Bacterial Agents
Clarithromycin
Azithromycin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors


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