Aizthromycin or Clarithromycin in H-pylori Eradication Regimen

Dyspepsia Clinical Trial

— H-pylori  

Official title:

Comparison of Azithromycin or Clarithromycin in 3drugs Protocol of H-pylori Eradication Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667692
• Other study ID #: ssu.hakimi-89027
• Status: Completed
• Phase: Phase 4
• First received: August 12, 2012
• Last updated: August 15, 2012
• Start date: March 2011
• Est. completion date: March 2012

Study information

• Verified date: August 2012
• Source: Shahid Sadoughi University of Medical Sciences and Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of health and medical education
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: March 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspepsia
• H-pylori
• Peptic Ulcer

Intervention

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.
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Behnam Baghianimoghadam	Yazd

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Sadoughi University of Medical Sciences and Health Services

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	H-pylori cinfirmation	confirmation is by endoscopy and biopsy	1-3 months before study	Yes
Secondary	h-pylori eradication confirmation	confirmation of eradication was by endoscopy and biopsy	two months after completion of 14 days standard treatment	Yes
Secondary	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.	during 14 days standard treatment	Yes