Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-04-12 @ 2:55 AM
Study NCT ID:
NCT06382493
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tegoprazan-containing Sequential for H. Pylori
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-30', 'studyFirstSubmitDate': '2024-04-20', 'studyFirstSubmitQcDate': '2024-04-20', 'lastUpdatePostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eradication rate', 'timeFrame': '2 or 3 month', 'description': 'Efficacy of H. pylori eradication therapy. confirmed by negative UBT test'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'up to 6 month', 'description': 'any adverse events occured during or after intervention (eradication therapy)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Helicobacter Pylori Infection']}, 'referencesModule': {'references': [{'pmid': '39434634', 'type': 'DERIVED', 'citation': 'Lee JW, Kim N, Lee J, Jo SY, Lee DH. Efficacy of Tegoprazan-Containing Sequential Eradication Treatment Compared to Esomeprazole-Containing Sequential Eradication of Helicobacter pylori in South Korea, a Region With High Antimicrobial Resistance: A Prospective, Randomized, Single Tertiary Center Study. Helicobacter. 2024 Sep-Oct;29(5):e13143. doi: 10.1111/hel.13143.'}]}, 'descriptionModule': {'briefSummary': 'As H. pylori eradication, the investigators prepared a randomized controlled clinical trial whether tegoprazan-containing 10-day sequential treatment was effective compared to conventional PPI-containing 10-day sequential eradication therapy', 'detailedDescription': 'Eradication treatment containing potassium-competitive acid blocker has shown acceptable eradication efficacy. In regions such as Korea, where the prevalence of antimicrobial resistance is high, alternative combinations of antibiotics such as sequential or concomitant therapy are needed. This study compared the outcome of sequential therapy containing tegoprazan, a new potassium-competitive acid blocker, with the conventional esomeprazole-containing sequential therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients who had H. pylori infection proved by positive test result of urea breath test (UBT), rapid urase test or pathologic examination (warthin-giemsa staining)\n\nExclusion Criteria:\n\n* congestive heart failure, NYHA III or IV\n* end-stage renal disease\n* alcoholics\n* drug abusers\n* pregnant or nursing women'}, 'identificationModule': {'nctId': 'NCT06382493', 'briefTitle': 'Tegoprazan-containing Sequential for H. Pylori', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Bundang Hospital'}, 'officialTitle': 'Efficacy of Tegoprazan-containing Sequential Therapy Compared to Proton Pump Inhibitor-based Eradication in South Korea, a Region With High Antimicrobial Resistance: A Prospective Randomized Single Tertiary Center Study', 'orgStudyIdInfo': {'id': 'B-2011-648-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Esomeprazole-containing sequential H. pylori eradication therapy (conventional method)', 'description': 'esomeprazole (40 mg) plus amoxicillin (1000 mg) twice a day for initial 5 days, and then esomeprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for the remaining 5 days.', 'interventionNames': ['Drug: Esomeprazole-containing sequential H. pylori eradication therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Tegoprazan-containing sequential H. pylori eradication therapy (experimental method)', 'description': 'tegoprazan (50 mg) plus amoxicillin (1000 mg) twice a day for initial 5 days, and then tegoprazan (50 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for the remaining 5 days.', 'interventionNames': ['Drug: Tegoprazan-containing sequential H. pylori eradication therapy']}], 'interventions': [{'name': 'Tegoprazan-containing sequential H. pylori eradication therapy', 'type': 'DRUG', 'description': 'tegoprazan was administered, instead propton-pump inhibitor, as acid blockade in H. pylori eradication sequential therapy', 'armGroupLabels': ['Tegoprazan-containing sequential H. pylori eradication therapy (experimental method)']}, {'name': 'Esomeprazole-containing sequential H. pylori eradication therapy', 'type': 'DRUG', 'description': 'Esomeprazole was administered as acid blockade in H. pylori eradication sequential therapy (conventional acid blockade method for sequential eradication therapy)', 'armGroupLabels': ['Esomeprazole-containing sequential H. pylori eradication therapy (conventional method)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Nayoung Kim, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'Jungwon Lee, Dr.', 'role': 'CONTACT', 'email': 'saludos@naver.com', 'phone': '821093567758'}], 'overallOfficials': [{'name': 'Nayoung Kim, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Nayoung Kim', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}