Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2025-12-25 @ 2:08 PM
Study NCT ID:
NCT04359966
Status:
UNKNOWN
Last Update Posted:
2020-04-24
First Post:
2020-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Randomised Trial of First and Second Line Treatments of RCT of First and Second Line H Pylori Treatments in Slovenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'D017291', 'term': 'Clarithromycin'}, {'id': 'D008795', 'term': 'Metronidazole'}, {'id': 'C002791', 'term': 'bismuth tripotassium dicitrate'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D064704', 'term': 'Levofloxacin'}, {'id': 'D015242', 'term': 'Ofloxacin'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'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'}, {'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': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised procpective multicenter trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 560}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-05-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-23', 'studyFirstSubmitDate': '2020-04-17', 'studyFirstSubmitQcDate': '2020-04-23', 'lastUpdatePostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of first line therapy for Helicobacter pylori infection', 'timeFrame': '2 years', 'description': 'Eradication rate'}, {'measure': 'Success rate of second line therapy for Helicobacter pylori infection', 'timeFrame': '3 years', 'description': 'Eradication rate'}], 'secondaryOutcomes': [{'measure': 'Helicobacter pylori resistance rate to antibiotics', 'timeFrame': '3 years', 'description': 'Culture and susceptibility testing'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Helicobacter pylori', 'First line treatment', 'Second line treatment', 'susceptibility to antibiotics'], 'conditions': ['Helicobacter Pylori Infection', 'Eradication Treatments']}, 'descriptionModule': {'briefSummary': 'Study is prospective randomised multicentric. The primary objective of the study is to compare the efficacy of two first-line therapy regimens and two second-line therapy regimens (ie, after failure of first-line treatment) in patients with H. pylori infection. The secondary objective of the study is to determine the primary resistance of H. pylori to antibiotics in Slovenia.', 'detailedDescription': "The infection with Helicobacter pylori is extremely widespread, as 60% of the world's population is infected. In Slovenia, the average prevalence is 25.1 %, the prevalence in the 20-year age group is 20 % and 76 % in patients in age group 50 - 75 years. All infected patients have active chronic gastritis, which is asymptomatic in most cases. Ulcers in the stomach or duodenum occurs in 15 % of patients. Due to chronic infection, MALT lymphoma or gastric cancer develop in 1 - 3 % of patients. According to the recommendations of the Slovenian Association for Gastroenterology and Hepatology, as well as European and other recommendations, everyone who is infected with Helicobacter pylori should be treated. H. pylori is a first-class carcinogen and is responsible for 50 % of all chronic cancer-causing infections in the developed world. Therefore, it is necessary to start programs of primary and secondary prevention of gastric cancer by searching and treating infected patients.\n\nPatients infected with H. pylori who have not yet been treated will be randomly assigned to two first-line treatment groups:\n\nGroup 1: Esomeprazole 40 mg, Clarithromycin 500 mg, Amoxicillin 1000 mg, all BID,14 days Group 2: Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg, all QID Esomeprazole 40 mg BID, 14 days\n\nPatients unsuccessfully treated with first-line therapy will be randomly assigned to two second-line treatment groups:\n\nGroup 1: Esomeprazole 40 mg BID, Levofloxacin 500 mg OID, Amoxicillin 1000 mg BID, 14 days Group 2: Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg, all QID, Esomeprazole 40 mg BID, 14 days\n\nInclusion criteria :\n\nPatients 18 to 80 years of age. Patients have not received proton pump inhibitors for the past 14 days. Patients did not receive antibiotics last month. Helicobacter pylori infection has been demonstrated by rapid urease test\n\nExclusion criteria :\n\nPrior treatment for Helicobacter pylori infection (in patients who will receive Schedule 1 eradication therapy).\n\nDefects in blood clotting. taking anticoagulant medicines that make it impossible to take biopsies.\n\nDrug allergy used in the study. Pregnancy, breastfeeding. Psychiatric illness that would prevent research participation. Active treatment for malignancy.\n\nStatistical analysis:\n\nTo describe the variables, we will use the average value and standard deviation for the symmetrically distributed variables or median and 25th and 75th percentiles for asymmetrically distributed variables. Investigators will use the t-test for dependent variables or, in the case of asymmetrically distributed variables, the Wilcoxon test. To determine the differences between the two groups (Group 1 and Group 2) of the subjects, t-test for independent samples Will be used, or in the case of an asymmetrically distributed variables Mann-Whitney test."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients 18 to 80 years of age.\n* Patients have not received proton pump inhibitors for the past 14 days.\n* Patients did not receive antibiotics in the last month.\n* Helicobacter pylori infection has been demonstrated by rapid urease test.\n\nExclusion Criteria:\n\n* Prior treatment for Helicobacter pylori infection (in patients who will receive Schedule 1 eradication therapy).•\n* Defects in blood clotting. taking anticoagulant medicines that make it impossible to take biopsies.\n* Allergy to drugs used in the study.\n* Pregnancy, breastfeeding shold be excluded.\n* Psychiatric illness that would prevent research participation.\n* Active treatment for malignancy.'}, 'identificationModule': {'nctId': 'NCT04359966', 'briefTitle': 'Prospective Randomised Trial of First and Second Line Treatments of RCT of First and Second Line H Pylori Treatments in Slovenia', 'organization': {'class': 'OTHER', 'fullName': 'Slovenian Society for Gastroenterology and Hepatology'}, 'officialTitle': 'Prospective Randomised Trial of First and Second Line Treatments of Helicobacter Pylori Infection in Slovenia', 'orgStudyIdInfo': {'id': 'SZGH Krka'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'First line therapy for H pylori infection', 'description': 'Tripple 14 day first line therapy Esomeprazole 40 mg, Clarithromycin 500 mg, Amoxicillin 1000 mg, all BID 14 days', 'interventionNames': ['Drug: Esomeprazole 40mg, Clarithromycin 500 mg, Metronidazole 400 mg,']}, {'type': 'EXPERIMENTAL', 'label': 'First line therapy for H pylori infection second arm', 'description': 'Bismuth quadruple first line therapy\n\nBismuth subcitrat 120 mg , Amoxicillin 500 mg, Metronidazole 400 mg, all QID, Esomeprazole 40 mg BID, 14 days.', 'interventionNames': ['Drug: Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Second line therapy for H pylori infection', 'description': 'Bismuth quadruple second line therapy for those treated with Tripple first line therapy\n\nBismuth subcitrat 120 mg , Amoxicillin 500 mg, Metronidazole 400 mg, all QID, Esomeprazole 40 mg BID, 14 days.', 'interventionNames': ['Drug: Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Second line therapy for H pylori infection second arm', 'description': 'Tripple second line therapy\n\nEsomeprazol 40 mg BID Amoxicillin 1000 mg BID, Levofloxacin 500 mg OID, 14 days or', 'interventionNames': ['Drug: Esomeprazole 40mg, Amoxicillin 500 mg, Levofloxacin 500 mg']}], 'interventions': [{'name': 'Esomeprazole 40mg, Clarithromycin 500 mg, Metronidazole 400 mg,', 'type': 'DRUG', 'otherNames': ['Emozul, Fromilid,Efloran'], 'description': 'First line therapy', 'armGroupLabels': ['First line therapy for H pylori infection']}, {'name': 'Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg', 'type': 'DRUG', 'otherNames': ['Emozul, Bismut oksid Krka, Hiconcil, Efloran'], 'description': 'First line therapy second arm', 'armGroupLabels': ['First line therapy for H pylori infection second arm']}, {'name': 'Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg', 'type': 'DRUG', 'otherNames': ['Emozul, Bismut oksid Krka, Hiconcil, Efloran'], 'description': 'Second line therapy for Helicobacter pylori infection', 'armGroupLabels': ['Second line therapy for H pylori infection']}, {'name': 'Esomeprazole 40mg, Amoxicillin 500 mg, Levofloxacin 500 mg', 'type': 'DRUG', 'otherNames': ['Emozul, Hiconcil,Tavanic'], 'description': 'Second line therapy for Helicobacter pylori infection second arm', 'armGroupLabels': ['Second line therapy for H pylori infection second arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4260', 'city': 'Bled', 'country': 'Slovenia', 'contacts': [{'name': 'Milan Stefanovič', 'role': 'CONTACT', 'email': 'milan.stefanovic@dc-bled.si'}, {'name': 'Milan Stefanovič, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'DC BLED', 'geoPoint': {'lat': 46.36859, 'lon': 14.11652}}, {'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'contacts': [{'name': 'Borut Stabuc, MD PhD', 'role': 'CONTACT', 'email': 'borut.stabuc@kclj.si'}, {'name': 'Borut Stabuc, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCC', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}, {'zip': '3250', 'city': 'Rogaška Slatina', 'country': 'Slovenia', 'contacts': [{'name': 'Prof B TEPES', 'role': 'CONTACT', 'email': 'bojan.tepes@siol.net', 'phone': '0038641325916', 'phoneExt': '0038641325916'}], 'facility': 'Am Dc Rogaska', 'geoPoint': {'lat': 46.23733, 'lon': 15.63912}}], 'centralContacts': [{'name': 'BOJAN TEPES', 'role': 'CONTACT', 'email': 'bojan.tepes@siol.net', 'phone': '0038641325916', 'phoneExt': '0038641325916'}], 'overallOfficials': [{'name': 'BOJAN TEPES', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AM DC Rogaška'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Slovenian Society for Gastroenterology and Hepatology', 'class': 'OTHER'}, 'collaborators': [{'name': 'KRKA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}