Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06101420
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2023-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Potassium Copetitive Acid Blockers Efficacy in H.Pylori Eradication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C552956', 'term': '1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine'}, {'id': 'D017291', 'term': 'Clarithromycin'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'D064704', 'term': 'Levofloxacin'}, {'id': 'C041747', 'term': 'nitazoxanide'}], 'ancestors': [{'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009853', 'term': 'Omeprazole'}, {'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': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 232}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-24', 'studyFirstSubmitDate': '2023-10-06', 'studyFirstSubmitQcDate': '2023-10-24', 'lastUpdatePostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'H.pylori eradication', 'timeFrame': 'six weeks', 'description': 'The rate of the patients who achieved H.pylori eradication as measured by negative H.Pylori stool antigen test in the four arms of the study was reported.'}], 'secondaryOutcomes': [{'measure': 'Safety of Vonoprazan use', 'timeFrame': 'six weeks', 'description': 'The number of patients who reported minor and major treatment connected adverse events in the four arms of the study was reported.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['P-CABs', 'Vonoprazan', 'H.pylori eradication'], 'conditions': ['Helicobacter Pylori Eradication']}, 'descriptionModule': {'briefSummary': 'This trial assessed the efficacy of potassium competetor acid blocker (P-CAB) in the eradication of H.pylori', 'detailedDescription': 'The aim of this study is to compare the effectiveness of Vonaprazan based therapy vs.Proton Pump Inhibitor (PPI)based therapy for the eradication of H.Pylori infection in treatment naive and treatment experienced Egyptian patients.This prospective, non- randomized, controlled study was conducted on symptomatic patients admitted at Tropical Medicine Department at Ain Shams University Hospitals and those presenting at outpatient clinic. The study was conducted in the period from the 1st of January 2022 to the 1st of June 2023.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age above 18 years of both genders.\n* Symptomatic patients who has been diagnosed to be H. pylori positive stool by using H. pylori stool antigen test.\n* Patients who did not receive H. pylori eradication regimens before were included in group I of the study (First line eradication regimen).\n* Patients who received only one eradication regimen before were included in group II of the study (Second line eradication regimen).\n* Patients signing an informed consent.\n\nExclusion Criteria:\n\n* Patients refusing to sign an informed consent.\n* Patients who were on PPIs, P-CABs and/or antibiotics starting one month before inclusion in the study .\n* Patients who have chronic debilitating and advanced systemic diseases.\n* Patients treated with low dose aspirin and/or non-steroidal anti-inflammatory drugs for a long time.\n* Any lactating or pregnant female.'}, 'identificationModule': {'nctId': 'NCT06101420', 'acronym': 'P-CABs', 'briefTitle': 'Potassium Copetitive Acid Blockers Efficacy in H.Pylori Eradication', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Efficacy of Potassium Competitive Acid Blockers (P-CABs) Versus Proton Pump Inhibitors (PPIs) in the First and the Second Lines Eradication Regimens for H. Pylori in Egyptian Patients', 'orgStudyIdInfo': {'id': '111954'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 Vonoprazn Triple Therapy Arm', 'description': 'Fifty eight participants.The patients received (Clarithromycin 500 mg tablets twice daily\\[BID\\]+ Amoxicillin 1gm capsules BID + Vonoprazan 20 mg tablets BID) for 14 days', 'interventionNames': ['Drug: Vonoprazan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2 Proton Pump Inhibitor Triple Therapy Arm', 'description': 'Fifty eight participants.The patients received the classic triple therapy (Clarithromycin 500 mg tablets BID + Amoxicillin 1gm capsules BID + Esomeprazole 20 mg tablets BID) for 14 days', 'interventionNames': ['Drug: Vonoprazan']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3 Vonoprazan Quadruple Therapy Arm', 'description': 'Fifty eight participants.The patients received a non-bismuth quadruple therapy (Levofloxacin 500 mg tablets once daily\\[OD\\] + Vonoprazan 20mg tablets BID + Nitazoxanide 500mg tablets BID +Doxycycline 100mg capsules OD) for 14 days.', 'interventionNames': ['Drug: Vonoprazan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 4 Proton Pump Inhibitor Quadruple Therapy Arm', 'description': 'Fifty eight participants.The patients received a non-bismuth quadruple therapy (Levofloxacin 500 mg tablets OD + Esomeprazole 20mg tablets BID + Nitazoxanide 500 mg tablets BID +Doxycycline 100mg capsules OD) for 14 days', 'interventionNames': ['Drug: Vonoprazan']}], 'interventions': [{'name': 'Vonoprazan', 'type': 'DRUG', 'otherNames': ['Clarithromycin', 'Amoxycillin', 'Esomeprazole', 'Levofloxacin', 'Doxycicline', 'Nitazoxanide'], 'description': 'Venoprazan 20mg twice daily,clarithromycin 500mg twice daily,amoxycillin 1 gm twice daily,esomeprazole 20mg twice daily,levofloxacin 500mg a single tablet daily,doxycicline 100mg a single capsule daily and nitazoxanide 500mg twice daily', 'armGroupLabels': ['Arm 1 Vonoprazn Triple Therapy Arm', 'Arm 2 Proton Pump Inhibitor Triple Therapy Arm', 'Arm 3 Vonoprazan Quadruple Therapy Arm', 'Arm 4 Proton Pump Inhibitor Quadruple Therapy Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11341', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Medicine Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Emeritus Professor', 'investigatorFullName': 'Reda Elwakil', 'investigatorAffiliation': 'Ain Shams University'}}}}