Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-01-05 @ 6:26 PM
Study NCT ID:
NCT07179159
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-17
First Post:
2025-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 372}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2025-08-30', 'studyFirstSubmitQcDate': '2025-09-10', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'eradication rate', 'timeFrame': '6 weeks after treatment'}], 'secondaryOutcomes': [{'measure': 'adverse events', 'timeFrame': 'immediately after a 2-week treatment'}, {'measure': 'compliance', 'timeFrame': 'immediately after a 2-week treatment', 'description': 'Satisfactory compliance was defined as taking medications with at least 80% of the prescribed dosage. The proportion of patients with satisfactory compliance was calculated among all patients.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HELICOBACTER PYLORI INFECTIONS']}, 'descriptionModule': {'briefSummary': 'This study is a multicentre, non-inferiority randomized controlled trial to compare the efficacy and safety of 14-day vonoprazan-based dual therapy with versus quadruple therapy for the eradication of Helicobacter pylori. The primary outcome is eradication rate, and the secondary outcome includes the incidence of adverse events and compliance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18-70 years, male or female\n2. Current Helicobacter pylori infection (positive 13C-urea breath test)\n3. No prior Helicobacter pylori eradication therapy\n\nExclusion Criteria:\n\n1. Severe underlying conditions, such as hepatic insufficiency, renal insufficiency, malignant tumours\n2. Active gastrointestinal bleeding\n3. History of upper gastrointestinal surgery\n4. History of drug hypersensitivity\n5. Use of bismuth compounds or antibiotics within the past 4 weeks, or acid-suppressing agents within the past 2 weeks\n6. Pregnant or lactating women\n7. Presence of other risk-increasing behaviours such as alcohol abuse or illicit drug use\n8. Individuals unable or unwilling to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07179159', 'briefTitle': 'Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Efficacy and Safety of 14-Day Vonoprazan-Based Dual Therapy Versus Quadruple Therapy for Helicobacter Pylori Eradication: A Multicentre, Non-Inferiority Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '202509'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '14-day vonoprazan-amoxicillin dual therapy', 'interventionNames': ['Drug: 14-day vonoprazan-amoxicillin dual therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy', 'interventionNames': ['Drug: 14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy', 'interventionNames': ['Drug: 14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy']}], 'interventions': [{'name': '14-day vonoprazan-amoxicillin dual therapy', 'type': 'DRUG', 'description': 'vonoprazan 20mg bid + amoxicillin 1000mg bid', 'armGroupLabels': ['14-day vonoprazan-amoxicillin dual therapy']}, {'name': '14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy', 'type': 'DRUG', 'description': 'vonoprazan 20mg bid + amoxicillin 1000mg bid + levofloxacin 500mg qd + bismuth 220mg bid', 'armGroupLabels': ['14-day vonoprazan-amoxicillin-levofloxacin-bismuth quadruple therapy']}, {'name': '14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy', 'type': 'DRUG', 'description': 'vonoprazan 20mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid + bismuth 220mg bid', 'armGroupLabels': ['14-day vonoprazan-amoxicillin-clarithromycin-bismuth quadruple therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jinan', 'country': 'China', 'contacts': [{'name': 'Yueyue Li', 'role': 'CONTACT', 'email': 'lyynqj@126.com', 'phone': '+8618560089751'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Yueyue Li', 'role': 'CONTACT', 'email': 'lyynqj@126.com', 'phone': '+8618560089751'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yanqing Li', 'class': 'OTHER'}, 'collaborators': [{'name': "Longkou People's Hospital", 'class': 'UNKNOWN'}, {'name': "Qingdao Jimo People's Hospital", 'class': 'OTHER'}, {'name': 'Shandong University of Traditional Chinese Medicine', 'class': 'OTHER'}, {'name': 'Dezhou Hospital Qilu Hospital of Shandong University', 'class': 'OTHER'}, {'name': 'Zibo Maternal and Child Health Hospital', 'class': 'UNKNOWN'}, {'name': "Guanxian People's Hospital", 'class': 'UNKNOWN'}, {'name': 'Yantai Zhifu Hospital', 'class': 'UNKNOWN'}, {'name': "The 2nd People's Hospital of Dongying City", 'class': 'UNKNOWN'}, {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Yanqing Li', 'investigatorAffiliation': 'Shandong University'}}}}