Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-26 @ 9:13 AM
Study NCT ID:
NCT01723059
Status:
UNKNOWN
Last Update Posted:
2012-11-07
First Post:
2012-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Standard Triple Therapy vs Sequential Therapy in Treatment of H Pylori Infection
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D017291', 'term': 'Clarithromycin'}, {'id': 'C107828', 'term': 'technetium Tc 99m 1,6-di-(2-thienyl)-2,5-diazahexane'}, {'id': 'D008795', 'term': 'Metronidazole'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 184}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-11-05', 'studyFirstSubmitDate': '2012-11-05', 'studyFirstSubmitQcDate': '2012-11-05', 'lastUpdatePostDateStruct': {'date': '2012-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Helicobacter pylori eradication', 'timeFrame': '4 weeks after completion of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Helicobacter Infection']}, 'descriptionModule': {'briefSummary': 'Traditionally, H pylori infection has been treated with conventional triple therapy. This includes amoxicillin, clarithromycin and a proton pump inhibitor all given daily for 10-14 days. In Europe, the guidelines now advocate treatment of H pylori with sequential therapy which is 5 days of amoxicillin therapy with proton pump inhibitor followed by 5 days of clarithromycin, metronidazole, and proton pump inhibitor with better response rates. We hypothesize that H. pylori resistance pattern and treatment response rates observed in Europe will not be predictive of resistance patterns and response rates in the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubject has signed informed consent Subject is an adult older than 18 yrs old and requires an upper endoscopic evaluation If female and of child bearing potential, subject has a negative pregnancy test and is not nursing.\n\nPatient has not received prior treatment for H pylori Subject is able to understand and comply with study procedures\n\nExclusion Criteria:\n\nRecent use (within 4 weeks) of any of the medications used in the treatment of H pylori(Amoxicillin, Clarithromycin, Metronidazole) Subject undergoing endoscopy for acute gastrointestinal bleeding Subject has an allergy to any of the medications used in the treatment of H pylori Subject has a history of esophageal or gastric carcinoma including lymphoma Subject has esophageal varices or undergoing endoscopy for esophageal banding Subject is taking warfarin or clopidogrel Subject has coagulopathy that precludes safe biopsy of the biopsy areas Subject has comorbidity that precludes safe participation in the study Subject is a pregnant female Subject has a history of H. pylori infection. Patient is already enrolled in GI Study. History of UGI surgery other than Nissen Fundoplication'}, 'identificationModule': {'nctId': 'NCT01723059', 'briefTitle': 'Standard Triple Therapy vs Sequential Therapy in Treatment of H Pylori Infection', 'organization': {'class': 'FED', 'fullName': 'Dallas VA Medical Center'}, 'officialTitle': 'Conventional Therapy vs Sequential Therapy for the Treatment of Helicobacter Pylori Infection', 'orgStudyIdInfo': {'id': '11-060'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard triple therapy', 'description': 'Gold standard for management of H pylori is amoxicillin 1 gm twice daily, clarithromycin 500 mg twice daily, and omeprazole 20 mg twice daily for 10 days.', 'interventionNames': ['Drug: Standard Triple Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sequential Therapy', 'description': 'Amoxicillin 1 gm twice daily and omeprazole 20 mg twice daily for 5 days followed by metronidazole 500 mg twice daily, clarithromycin 500 mg twice daily, and omeprazole 20 mg twice daily for 5 days.', 'interventionNames': ['Drug: Sequential Therapy']}], 'interventions': [{'name': 'Standard Triple Therapy', 'type': 'DRUG', 'otherNames': ['Amoxicillin 1000 mg orally twice daily', 'Omeprazole 20 mg orally twice daily', 'Clarithromycin 500 mg orally twice daily'], 'description': 'for 10 days', 'armGroupLabels': ['Standard triple therapy']}, {'name': 'Sequential Therapy', 'type': 'DRUG', 'otherNames': ['Amoxicillin 1000 mg orally twice daily for 5 days', 'Omeprazole 20 mg orally twice daily for 5 days', 'Then', 'Clarithromycin 500 mg orally twice daily for 5 days', 'Metronidazole 500 mg orally twice daily for 5 days'], 'description': 'total 10 days', 'armGroupLabels': ['Sequential Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75216', 'city': 'Dallas', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Byron Cryer, MD', 'role': 'CONTACT', 'email': 'byron.cryer@utsouthwestern.edu'}], 'facility': 'Dallas VAMC', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'centralContacts': [{'name': 'Byron Cryer, MD', 'role': 'CONTACT', 'email': 'byron.cryer@utsouthwestern.edu', 'phone': '214-857-1603'}, {'name': 'Elizabeth Coss, MD', 'role': 'CONTACT', 'email': 'elizabeth.coss@phhs.org', 'phone': '817-896-7030'}], 'overallOfficials': [{'name': 'Byron Cryer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gastroenterologist, MD VA'}, {'name': 'Robert Genta, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Pathologist, MD'}, {'name': 'Elizabeth Coss, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Gastroenterology Fellow, MD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dallas VA Medical Center', 'class': 'FED'}, 'collaborators': [{'name': 'Otsuka Pharmaceutical Development & Commercialization, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Gastroenterologist', 'investigatorFullName': 'Byron Cryer', 'investigatorAffiliation': 'Dallas VA Medical Center'}}}}