Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT04558502
Status:
UNKNOWN
Last Update Posted:
2022-01-13
First Post:
2020-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Minocycline-Containing Bismuth Quadruple Therapy for Helicobacter Pylori Eradication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562573', 'term': 'cyclopia sequence'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008911', 'term': 'Minocycline'}, {'id': 'D017291', 'term': 'Clarithromycin'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 339}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-12-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-26', 'studyFirstSubmitDate': '2020-09-15', 'studyFirstSubmitQcDate': '2020-09-20', 'lastUpdatePostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eradication rate', 'timeFrame': '4-12 weeks after treatment', 'description': 'Helicobacter pylori eradication of minocycline-containing bismuth quadruple therapy'}], 'secondaryOutcomes': [{'measure': 'incidence of adverse effects', 'timeFrame': '3-7 days after treatment', 'description': 'incidence of adverse effects of minocycline-containing bismuth quadruple therapy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Helicobacter pylori', 'Eradication', 'minocycline', 'bismuth quadruple regimens'], 'conditions': ['Helicobacter Pylori Eradication']}, 'descriptionModule': {'briefSummary': 'Although,bismuth-containing quadruple therapy has been highly recommended as first-line treatment regimen for H.pylori infection,it also has its problems and limitations in China.The primary resistance rates of metronidazole,clarithromycin and levofloxacin are all high in China.Besides that,tetracycline cannot be obtained and its complicated administration (four times daily) easily reduce patient compliance. In this study, we proposed to evaluate the eradication rate, safety, and compliance of a minocycline-based bismuth quadruple regimen.', 'detailedDescription': 'A total of 339 H. pylori-infected, treatment-naive patients will be enrolled in this randomized controlled clinical trial. Patients will be randomly allocated into 3 groups: Esomeprazole 20 mg, clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days; Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days; Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days. Eradication rates will be assessed 4-12 weeks after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* H.pylori-positive outpatients with endoscopically proven chronic gastritis\n* H. pylori (+) determined by either the 14C-or 13C-urea breath test or the gastric mucosal tissue rapid urease test and pathological section staining\n* Treatment-naive patients for eradication of H.pylori infection\n* Fully informed and agreed to participate in this study\n\nExclusion Criteria:\n\n* Age \\<18 years or \\>70 years\n* Allergy to any of the study drugs\n* Use of any drug that could influence the study results 4 weeks before the study,such as antibiotics,bismuth agent,PPI or H2 receptor antagonist (H2RA)\n* Previous gastric or esophageal surgery\n* Patients with malignancy or severe comorbidity\n* Pregnancy,lactation or alcohol abuse\n* Patients with poor treatment compliance or could not express themselves correctly\n* Participation in other clinical studies recently (within 3 months of enrollment in this clinical study)'}, 'identificationModule': {'nctId': 'NCT04558502', 'briefTitle': 'Effectiveness of Minocycline-Containing Bismuth Quadruple Therapy for Helicobacter Pylori Eradication', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Effectiveness of Minocycline-Containing Bismuth Quadruple Therapy as First-Line Regimen for Helicobacter Pylori Eradication', 'orgStudyIdInfo': {'id': '2020-584'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'minocycline-based bismuth quadruple regimen for 14 days', 'description': 'Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.', 'interventionNames': ['Drug: Minocycline hydrochloride capsule', 'Drug: Amoxicillin', 'Drug: colloidal bismuth pectin', 'Drug: esomeprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'clarithromycin-based bismuth quadruple regimen for 14 days', 'description': 'Esomeprazole 20 mg,clarithromycin 500 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 14 days.', 'interventionNames': ['Drug: Clarithromycin', 'Drug: Amoxicillin', 'Drug: colloidal bismuth pectin', 'Drug: esomeprazole']}, {'type': 'EXPERIMENTAL', 'label': 'minocycline-based bismuth quadruple regimen for 10 days', 'description': 'Esomeprazole 20 mg, minocycline 100 mg, amoxicillin 1000 mg, and colloidal bismuth pectin 200 mg twice daily for 10 days.', 'interventionNames': ['Drug: Minocycline hydrochloride capsule', 'Drug: Amoxicillin', 'Drug: colloidal bismuth pectin', 'Drug: esomeprazole']}], 'interventions': [{'name': 'Minocycline hydrochloride capsule', 'type': 'DRUG', 'otherNames': ['Meiman'], 'description': 'Antibiotic for H. pylori eradication', 'armGroupLabels': ['minocycline-based bismuth quadruple regimen for 10 days', 'minocycline-based bismuth quadruple regimen for 14 days']}, {'name': 'Clarithromycin', 'type': 'DRUG', 'otherNames': ['Klacid'], 'description': 'Antibiotic for H. pylori eradication', 'armGroupLabels': ['clarithromycin-based bismuth quadruple regimen for 14 days']}, {'name': 'Amoxicillin', 'type': 'DRUG', 'description': 'Antibiotic for H. pylori eradication', 'armGroupLabels': ['clarithromycin-based bismuth quadruple regimen for 14 days', 'minocycline-based bismuth quadruple regimen for 10 days', 'minocycline-based bismuth quadruple regimen for 14 days']}, {'name': 'colloidal bismuth pectin', 'type': 'DRUG', 'description': 'Gastric mucosal protective drug with anti-H. pylori effect', 'armGroupLabels': ['clarithromycin-based bismuth quadruple regimen for 14 days', 'minocycline-based bismuth quadruple regimen for 10 days', 'minocycline-based bismuth quadruple regimen for 14 days']}, {'name': 'esomeprazole', 'type': 'DRUG', 'description': 'Proton pump inhibitor', 'armGroupLabels': ['clarithromycin-based bismuth quadruple regimen for 14 days', 'minocycline-based bismuth quadruple regimen for 10 days', 'minocycline-based bismuth quadruple regimen for 14 days']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yan Li, master', 'role': 'CONTACT', 'email': 'liyan_8786@zju.edu.cn', 'phone': '15906698496'}, {'name': 'Yuehua Han, PhD', 'role': 'CONTACT', 'email': '13858126927@163.com', 'phone': '13858126927'}], 'overallOfficials': [{'name': 'Qin Du, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '2nd Affiliated Hospital,School of Medicine,Zhejiang University,China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}