Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2026-02-22 @ 9:04 AM
Study NCT ID:
NCT02395458
Status:
COMPLETED
Last Update Posted:
2015-03-23
First Post:
2015-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy on Helicobacter Pylori Eradication With Two Antibiotic Regimens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016481', 'term': 'Helicobacter Infections'}], 'ancestors': [{'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-17', 'studyFirstSubmitDate': '2015-03-12', 'studyFirstSubmitQcDate': '2015-03-17', 'lastUpdatePostDateStruct': {'date': '2015-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eradication', 'timeFrame': '6 to 8 week after treatment', 'description': 'Helicobacter pylori in gastric biopsy'}], 'secondaryOutcomes': [{'measure': 'Side effects', 'timeFrame': 'two weeks after beginning of treatment', 'description': 'Nausea, vomiting, stomach ache'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sequential therapy', 'Triple therapy', 'Eradication'], 'conditions': ['Helicobacter Infections']}, 'descriptionModule': {'briefSummary': 'Clinical trial to compare efficacy on eradicating Helicobacter pylori with two antibiotic strategies: sequential with amoxicillin and omeprazole 5 days and clarithromycin with metronidazole and omeprazole 5 days or omeprazole with clarithromycin and amoxicillin 14 days.', 'detailedDescription': 'In patients with documented infection with Helicobacter pylori after endoscopy and biopsy, two modalities of treatment were compared, and after a control endoscopy and biopsy, eradication was assessed as well as side effects of both treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Helicobacter pylori infection in biopsy\n* Eradication required\n\nExclusion Criteria:\n\n* Antibiotic received two weeks prior\n* Previous treatment for H pylori infection\n* Allergy to any of the treatment drugs\n* Smoking \\> 5 cigarettes daily.'}, 'identificationModule': {'nctId': 'NCT02395458', 'briefTitle': 'Efficacy on Helicobacter Pylori Eradication With Two Antibiotic Regimens', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Coordinación de Investigación en Salud, Mexico'}, 'officialTitle': 'Efficacy on Helicobacter Pylori Eradication With Sequential Antibiotic Compared to Triple Therapy for 14 Days', 'orgStudyIdInfo': {'id': 'R-2013-3609-22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequential therapy', 'description': 'Patient receive Omeprazole plus amoxicillin during 5 days and then omeprazole plus clarithromycin and metronidazole during another 5 days', 'interventionNames': ['Drug: Sequential therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Triple therapy', 'description': 'Patient receive Omeprazole plus clarithromycin and amoxicillin during 14 days', 'interventionNames': ['Drug: Triple therapy']}], 'interventions': [{'name': 'Sequential therapy', 'type': 'DRUG', 'otherNames': ['Omeprazole-Amoxicillin-Clarithromycin-Metronidazole'], 'description': 'Patient receive Omeprazole plus amoxicillin during 5 days and then omeprazole plus clarithromycin and metronidazole during another 5 days', 'armGroupLabels': ['Sequential therapy']}, {'name': 'Triple therapy', 'type': 'DRUG', 'otherNames': ['Omeprazole-Clarithromycin-Metronidazole'], 'description': 'Patient receive Omeprazole plus amoxicillin and Clarithromycin during 14 days', 'armGroupLabels': ['Triple therapy']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coordinación de Investigación en Salud, Mexico', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Clinical Research Centre', 'investigatorFullName': 'Jorge Escobedo de la Pena', 'investigatorAffiliation': 'Coordinación de Investigación en Salud, Mexico'}}}}