Aizthromycin or Clarithromycin in H-pylori Eradication Regimen

Phase 4

Completed

• Conditions: Peptic Ulcer; H-pylori; Dyspepsia
• Interventions: Drug: clarithmycin; Drug: azithromycin

• Registration Number: NCT01667692
• Lead Sponsor: Shahid Sadoughi University of Medical Sciences and Health Services

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.

Study Timeline

• Study Start: 2011-03
• Primary Completion: 2011-11
• Study Completion: 2012-03
• Status Verified: 2012-08
• Study First Submitted: 2012-08-12
• Study First Submitted QC: 2012-08-15
• Last Update Submitted: 2012-08-15
• Study First Posted: 2012-08-17
• Last Update Posted: 2012-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
clarithromycin	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.
azithromycin	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.

Primary Outcome Measures

Name	Time	Method
H-pylori cinfirmation	1-3 months before study	confirmation is by endoscopy and biopsy

Secondary Outcome Measures

Name	Time	Method
h-pylori eradication confirmation	two months after completion of 14 days standard treatment	confirmation of eradication was by endoscopy and biopsy
side effect of study srugs	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.

Trial Locations

Locations (1)

Behnam Baghianimoghadam; 🇮🇷 Yazd, Iran, Islamic Republic of