Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 9:29 PM
Study NCT ID:
NCT04432233
Status:
UNKNOWN
Last Update Posted:
2020-08-27
First Post:
2020-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravenous Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'D008795', 'term': 'Metronidazole'}, {'id': 'D064704', 'term': 'Levofloxacin'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-25', 'studyFirstSubmitDate': '2020-06-11', 'studyFirstSubmitQcDate': '2020-06-12', 'lastUpdatePostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-15', 'type': 'ESTIMATED'}}, '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-urea breath test. Eradication was defined as negative result from urea breath test (\\<4‰) (4‰ as the cutoff value).'}], 'secondaryOutcomes': [{'measure': 'Rate of adverse effects', 'timeFrame': 'Within 7 days after completion of therapy'}, {'measure': 'Rate of stop bleeding', 'timeFrame': 'Within 7 days after completion of therapy'}, {'measure': 'Rate of pyloric obstruction remission', 'timeFrame': 'Within 7 days after completion of therapy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Helicobacter Pylori Infection', 'Intravenous Drug Usage'], 'conditions': ['Helicobacter Pylori Infection', 'Intravenous Drug Usage']}, 'descriptionModule': {'briefSummary': 'Helicobacter pylori infection causes active peptic ulcer disease and related complications like bleeding and pyloric obstruction. Usually, clinicians tended to treat Helicobacter pylori infection after active peptic ulcer disease and related complicaitons getting healed, which spent time and money. This study is designed to evaluate the efficacy and safety of intravenous administration of metronidazole, levofloxacin and esomeprazole triple therapy in the treatment of Helicobacter pylori infection combined with peptic ulcer disease related complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged between 18 and 75 years old\n* Without previous Helicobacter pylori treatment\n* Diagnosed with active peptic ulcer disease and related complications like bleeding and pyloric obstruction by endoscopy examination\n* Ability and willingness to participate in the study and to sign and give informed consent\n* Positive for Helicobacter pylori IgM antibody\n\nExclusion Criteria:\n\n* With previous gastric surgery\n* Major systemic diseases\n* Pregnancy or lactation\n* Allergy to any of the study drugs\n* Decline to participate in the study'}, 'identificationModule': {'nctId': 'NCT04432233', 'briefTitle': 'Intravenous Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Intravenous Administration of Metronidazole, Levofloxacin and Esomeprazole Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease', 'orgStudyIdInfo': {'id': 'rjkls2020031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous therapy', 'description': 'Subjected enrolled will receive (a) a 10-day intravenous triple therapy containing esomeprazole 40 mg thrice a day, metronidazole 500 mg twice a day and levofloxacin 500 mg once a day and (b) esomeprazole 20 mg twice a day taken orally for 8 weeks.', 'interventionNames': ['Drug: Esomeprazole', 'Drug: Metronidazole', 'Drug: Levofloxacin']}], 'interventions': [{'name': 'Esomeprazole', 'type': 'DRUG', 'description': 'Proton pump inhibitor', 'armGroupLabels': ['Intravenous therapy']}, {'name': 'Metronidazole', 'type': 'DRUG', 'description': 'antibiotic for H. pylori eradication', 'armGroupLabels': ['Intravenous therapy']}, {'name': 'Levofloxacin', 'type': 'DRUG', 'description': 'antibiotic for H. pylori eradication', 'armGroupLabels': ['Intravenous therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiao Liang, PHD,MD', 'role': 'CONTACT', 'email': 'xliang5515@gmail.com', 'phone': '13120839615'}], 'facility': 'Renji Hospital, School of Medicine, Shanghai Jiao Tong University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xiao Liang, PHD,MD', 'role': 'CONTACT', 'email': 'xliang5515@gmail.com', 'phone': '13120839615'}], 'overallOfficials': [{'name': 'Hong Lu, PHD,MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Renji Hospital, School of Medicine, Shanghai Jiao Tong University'}]}, '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': 'Shanghai Jiao Tong University School of Medicine'}}}}