Aizthromycin or Clarithromycin in H-pylori Eradication Regimen
This study has been completed.
Sponsor:
Shahid Sadoughi University of Medical Sciences and Health Services
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
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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:
Drug Information available for:
Clarithromycin
Azithromycin
Azithromycin dihydrate
Azithromycin monohydrate
U.S. FDA Resources
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 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:
|
Dyspepsia Peptic Ulcer Ulcer Signs and Symptoms, Digestive Signs and Symptoms Duodenal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Stomach Diseases |
Pathologic Processes Anti-Bacterial Agents Azithromycin Clarithromycin Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013