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Completed

NCT Number: NCT01667692

Aizthromycin or Clarithromycin in H-pylori Eradication Regimen

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

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Key information

Conditions

Peptic Ulcer Digestive System Diseases Duodenal Diseases Dyspepsia Gastrointestinal Diseases H-pylori Intestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Stomach Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Behnam Baghianimoghadam

Yazd, Yazd Province, 8916863411, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azithromycin

Drug

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 names: (Zithromax, Azithrocin

clarithmycin

Drug

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 names: Crixan, Claritt, Clarac, Biaxin, Klaricid, Klacid...

Primary outcomes

  1. H-pylori cinfirmation

    Time frame: 1-3 months before study

    confirmation is by endoscopy and biopsy

Secondary outcomes

  1. h-pylori eradication confirmation

    Time frame: two months after completion of 14 days standard treatment

    confirmation of eradication was by endoscopy and biopsy

  2. 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.

Sponsors and collaborators

Lead sponsor

Shahid Sadoughi University of Medical Sciences and Health Services

Other

Registry information

Official study title

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

Acronym: H-pylori

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Aug 17, 2012
Registry last updated
Aug 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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