Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-02-26 @ 11:54 PM
Study NCT ID:
NCT01667692
Status:
COMPLETED
Last Update Posted:
2012-08-17
First Post:
2012-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aizthromycin or Clarithromycin in H-pylori Eradication Regimen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004415', 'term': 'Dyspepsia'}], 'ancestors': [{'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D017291', 'term': 'Clarithromycin'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-15', 'studyFirstSubmitDate': '2012-08-12', 'studyFirstSubmitQcDate': '2012-08-15', 'lastUpdatePostDateStruct': {'date': '2012-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'H-pylori cinfirmation', 'timeFrame': '1-3 months before study', 'description': 'confirmation is by endoscopy and biopsy'}], 'secondaryOutcomes': [{'measure': 'h-pylori eradication confirmation', 'timeFrame': 'two months after completion of 14 days standard treatment', 'description': 'confirmation of eradication was by endoscopy and biopsy'}, {'measure': 'side effect of study srugs', 'timeFrame': 'during 14 days standard treatment', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['H-pylori', 'eradication', 'azithromycin', 'clarithromycin'], 'conditions': ['Peptic Ulcer', 'Dyspepsia', 'H-pylori']}, 'descriptionModule': {'briefSummary': 'The Aim of this study is comparison between two regimens containing clarithromycinand azithromycin.', 'detailedDescription': 'Eradication of helicobacter pylori is important for treatment of GU but ideal regimen is not available.\n\nHP is resistant to metronidazole and clarithromycin, thus clarithromycin is expensive and it is not available in underdevelopment countries.\n\nThere 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.\n\nThe Aim of this study is comparison between two regimens containing clarithromycinand azithromycin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with peptic ulcer due to H-pylori confirmed endoscopy and biopsy\n\nExclusion Criteria:\n\n* patients who got H-pylori eradication treatment previously\n* patients who used study drugs during 3months before study'}, 'identificationModule': {'nctId': 'NCT01667692', 'acronym': 'H-pylori', 'briefTitle': 'Aizthromycin or Clarithromycin in H-pylori Eradication Regimen', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Sadoughi University of Medical Sciences and Health Services'}, 'officialTitle': 'Comparison of Azithromycin or Clarithromycin in 3drugs Protocol of H-pylori Eradication Regimen', 'orgStudyIdInfo': {'id': 'ssu.hakimi-89027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'azithromycin', 'description': "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.", 'interventionNames': ['Drug: azithromycin']}, {'type': 'EXPERIMENTAL', 'label': 'clarithromycin', 'description': '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.', 'interventionNames': ['Drug: clarithmycin']}], 'interventions': [{'name': 'azithromycin', 'type': 'DRUG', 'otherNames': ['(Zithromax, Azithrocin'], 'description': "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.", 'armGroupLabels': ['azithromycin']}, {'name': 'clarithmycin', 'type': 'DRUG', 'otherNames': ['Crixan, Claritt, Clarac, Biaxin, Klaricid, Klacid...'], 'description': '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.', 'armGroupLabels': ['clarithromycin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8916863411', 'city': 'Yazd', 'state': 'Yazd Province', 'country': 'Iran', 'facility': 'Behnam Baghianimoghadam', 'geoPoint': {'lat': 31.89722, 'lon': 54.3675}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Sadoughi University of Medical Sciences and Health Services', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'research consultant', 'investigatorFullName': 'Behnam Baghianimoghadam', 'investigatorAffiliation': 'Shahid Sadoughi University of Medical Sciences and Health Services'}}}}