Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT05901051
Status:
COMPLETED
Last Update Posted:
2024-12-30
First Post:
2023-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
High-dose Dual Therapy with Different Administration Frequencies
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': 'D000658', 'term': 'Amoxicillin'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 327}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-26', 'studyFirstSubmitDate': '2023-02-24', 'studyFirstSubmitQcDate': '2023-06-04', 'lastUpdatePostDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Helicobacter pylori eradication rate', 'timeFrame': 'Six weeks after completion of therapy', 'description': 'Six weeks after completion of therapy, H. pylori eradication was assessed by ¹³C-rea breath test. Eradication was defined as negative result from urea breath test (\\<4‰) (4‰ as the cutoff value).'}], 'secondaryOutcomes': [{'measure': 'Rate of adverse events', 'timeFrame': 'Within 7 days after completion of therapy', 'description': 'The subjects were asked to record side effects and discomfort during treatment and actual drug administration.'}, {'measure': 'Compliance rate', 'timeFrame': 'Within 7 days after completion of therapy', 'description': 'Compliance was defined as poor when they had taken less than 80% of the total medication'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Helicobacter pylori', 'Dual Therapy'], 'conditions': ['Helicobacter Pylori Infection']}, 'referencesModule': {'references': [{'pmid': '39087868', 'type': 'DERIVED', 'citation': 'Qiu S, Huang Y, Chen J, Guo Y, Li M, Ding Z, Liang X, Lu H. Vonoprazan-Amoxicillin Dual Therapy With Different Amoxicillin Administration Regimens for Helicobacter pylori Treatment: A Randomized Controlled Trial. Helicobacter. 2024 Jul-Aug;29(4):e13118. doi: 10.1111/hel.13118.'}]}, 'descriptionModule': {'briefSummary': 'This study is a single center, randomized controlled clinical study. The enrolled patients are HP positive. They are diagnosed as HP positive by rapid urease test and/or 13C urea breath test. According to the declaration of Helsinki, 327 patients will be included in this study. After obtaining the written informed consent of the patients, HP culture and drug sensitivity test will be conducted on all the selected patients with the success rate, adverse reactions, compliance, antibiotic resistance of HP and its impact on HP eradication.', 'detailedDescription': 'According to relevant literature research, amoxicillin TID groups (including before meal group and after meal group) were given Vonorasen (Takeda China) 20mg bid and Amoxicillin 1.0 TID (Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd.). Amoxicillin Qid group was given Vonorasen (Takeda China) 20mg bid and Amoxicillin 0.75 Qid (Zhejiang Jinhua Kangenbei biopharmaceutical Co., Ltd.), all the drugs were purchased by the patients from the hospital. The three groups were treated for 14 days respectively, and 13C urea breath test was performed 6 weeks after drug withdrawal. The negative ones were judged as HP eradication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability and willingness to participate in the study and to sign and give informed consent\n* Confirmed H. pylori infection\n\nExclusion Criteria:\n\n* Pregnant and lactating women;\n* History of gastrointestinal malignancies;\n* History of previous subtotal gastrectomy;\n* Serious dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases; Such as grade IV cardiac insufficiency, liver failure, uremia, respiratory failure, hemophilia, Wilson disease, etc;\n* History of hematological diseases\n* People who are allergic to drugs;\n* The guardian or patient refused to join the group;\n* Alcohol and / or drug abuse (addiction or dependence) or poor compliance judged by doctors;\n* No legal capacity or poor self-knowledge\n* administration of antibiotics, bismuth, antisecretory drugs, or Chinese herb medicine in the preceding 8 weeks'}, 'identificationModule': {'nctId': 'NCT05901051', 'briefTitle': 'High-dose Dual Therapy with Different Administration Frequencies', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Randomized and Controlled Clinical Study of High-dose Dual Therapy with Different Administration Frequencies in the Treatment of Helicobacter Pylori', 'orgStudyIdInfo': {'id': 'rjyy20210815'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dual therapy A', 'description': 'Vonoprazan 20mg bid ac and amoxicillin 0.75g qid pc', 'interventionNames': ['Drug: vonoprazan', 'Drug: Amoxicillin']}, {'type': 'EXPERIMENTAL', 'label': 'dual therapy B', 'description': 'Vonoprazan 20mg bid ac and amoxicillin 1g tid pc', 'interventionNames': ['Drug: vonoprazan', 'Drug: Amoxicillin']}, {'type': 'EXPERIMENTAL', 'label': 'dual therapy C', 'description': 'Vonoprazan 20mg bid ac and amoxicillin 1g tid ac', 'interventionNames': ['Drug: vonoprazan', 'Drug: Amoxicillin']}], 'interventions': [{'name': 'vonoprazan', 'type': 'DRUG', 'description': 'Potassium competitive acid blocker', 'armGroupLabels': ['dual therapy A', 'dual therapy B', 'dual therapy C']}, {'name': 'Amoxicillin', 'type': 'DRUG', 'description': 'Antibiotics for H. pylori eradication', 'armGroupLabels': ['dual therapy A', 'dual therapy B', 'dual therapy C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Renji Hospital, School of Medicine, Shanghai Jiao Tong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor of Division of Gastroenterology and Hepatology of Renji Hospital,Professor of Medicine', 'investigatorFullName': 'Hong Lu, MD', 'investigatorAffiliation': 'RenJi Hospital'}}}}