Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-30 @ 8:37 AM
Study NCT ID:
NCT05614934
Status:
COMPLETED
Last Update Posted:
2025-02-21
First Post:
2022-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vonoprazan-based Therapy Versus Standard Regimen for Helicobacter Pylori Infection Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open-labeled, prospective, three-arm, parallel-group, non-placebo Randomized controlled clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2022-11-07', 'studyFirstSubmitQcDate': '2022-11-07', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of the eradication rates for each regimen', 'timeFrame': '1.5 month', 'description': 'Percentage eradication in each group is calculated by intention-to-treat analysis or per-protocol analysis.'}], 'secondaryOutcomes': [{'measure': 'Determination of number of compliant participants to each regimen', 'timeFrame': '1.5 month', 'description': 'Adherence to therapies is determined through pill count in medication boxes In addition to reviewing a daily medication schedule filled by the participant.'}, {'measure': 'Determination of number of participants with treatment related adverse events', 'timeFrame': '2 weeks', 'description': 'Patients will be contacted on a regular basis to monitor any reported adverse events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Helicobacter Pylori', 'vonoprazan', 'standard triple therapy'], 'conditions': ['Helicobacter Pylori Infection']}, 'referencesModule': {'references': [{'pmid': '40341536', 'type': 'DERIVED', 'citation': 'Shekeban YM, Hamdy NA, Header DA, Ahmed SM, Helmy MM. Vonoprazan-based therapy versus standard regimen for Helicobacter pylori infection management in Egypt: an open-label randomized controlled trial. Sci Rep. 2025 May 8;15(1):15989. doi: 10.1038/s41598-025-98606-8.'}]}, 'descriptionModule': {'briefSummary': 'Appropriately, half of the global population is infected with H. pylori, and it is now recognized that it causes at least 95% of all gastric cancers. Currently, the main challenge in the field of H. pylori infection is the rapidly increasing antibiotic resistance worldwide, which is causing a decline in the effectiveness of currently available eradication regimens.\n\nThe aim of the study is to assess the safety and efficacy of different H. pylori vonoprazan-based regimens compared to the commonly used standard triple therapy composed of Clarithromycin, Amoxicillin, and Proton pump inhibitor to eradicate H. pylori infection in treatment-naive patients through the determination of each regimen eradication rate and reported safety profile', 'detailedDescription': "1. Ethical committee approval is obtained from Ethics committee of Faculty of Medicine, Alexandria University.\n2. All participants should agree to take part in this clinical study and will provide informed consent.\n3. Patients with suspected H. pylori infection are recruited from Alexandria University out-patient clinics\n4. Participants' demographic data, Full medical and medication history, and detailed clinical presentation is documented\n5. Participants are tested for H. pylori infection using rapid H. pylori stool antigen test device\n6. Negative subjects are excluded while positive patients are randomly allocated to 3 groups of different H. pylori regimens (Standard triple, Vonoprazan dual, and Vonoprazan triple)\n7. Following up treatment side effects while taking the medications.\n8. Assessing regimens effectiveness through patient retesting at least 1 month after treatment completion.\n9. Assessing patient compliance to different regimens during the final visit.\n10. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.\n11. Results, conclusion, discussion and recommendations will be given."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with positive stool antigen test result for H. pylori\n* Patients recently diagnosed with H. pylori infection and did not receive any treatment\n\nExclusion Criteria:\n\n* Patients sensitive to any of the regimens' components\n* Patients who had received a previous eradication therapy and still show positive test results\n* Recent use of antimicrobial agents, proton pump inhibitors, and H2 receptor blockers within 1 month\n* Patients with gastric malignancy or who underwent previous gastric surgery\n* Pregnancy and lactation\n* Patients with major concomitant diseases, including psychic disorders"}, 'identificationModule': {'nctId': 'NCT05614934', 'briefTitle': 'Vonoprazan-based Therapy Versus Standard Regimen for Helicobacter Pylori Infection Management', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Vonoprazan-based Therapy Versus Standard Regimen for Helicobacter Pylori Infection Management', 'orgStudyIdInfo': {'id': '0107175'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'S3', 'description': 'Standard clarithromycin triple', 'interventionNames': ['Drug: standard Clarithromycin triple therapy']}, {'type': 'EXPERIMENTAL', 'label': 'V3', 'description': 'Vonoprazan triple', 'interventionNames': ['Drug: Vonoprazan triple therapy']}, {'type': 'EXPERIMENTAL', 'label': 'V2', 'description': 'Vonoprazan dual', 'interventionNames': ['Drug: Vonoprazan dual therapy']}], 'interventions': [{'name': 'standard Clarithromycin triple therapy', 'type': 'DRUG', 'description': 'Oral administration of proton pump inhibitor standard or double dose twice daily, clarithromycin 500 mg twice daily and, Amoxicillin1g twice daily for 14 days', 'armGroupLabels': ['S3']}, {'name': 'Vonoprazan triple therapy', 'type': 'DRUG', 'description': 'Oral administration of Vonoprazan 20mg twice daily, clarithromycin 500 mg twice daily, and, Amoxicillin1g twice daily for 14 days', 'armGroupLabels': ['V3']}, {'name': 'Vonoprazan dual therapy', 'type': 'DRUG', 'description': 'Oral administration of Vonoprazan 20mg twice daily and, Amoxicillin1g three times daily for 14 days', 'armGroupLabels': ['V2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Alexandria University outpatient clinics', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Teaching Assistant at clinical pharmacy and pharmacy practice department, faculty of pharmacy Alexandria University', 'investigatorFullName': 'Yumna Mohamed Shekeban', 'investigatorAffiliation': 'Alexandria University'}}}}