Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT03498456
Status:
COMPLETED
Last Update Posted:
2020-05-08
First Post:
2018-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Triple Therapy With Tegoprazan in H. Pylori Positive Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000631239', 'term': 'tegoprazan'}, {'id': 'D064747', 'term': 'Lansoprazole'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 284}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-06', 'studyFirstSubmitDate': '2018-04-08', 'studyFirstSubmitQcDate': '2018-04-08', 'lastUpdatePostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'H. pylori eradication rate', 'timeFrame': '6 weeks', 'description': "Subjects will be considered to succeed in achieving H. pylori eradication if subjects's negative UBT test."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Helicobacter Pylori Infection']}, 'descriptionModule': {'briefSummary': 'The current study is designed to demonstrate the non-inferiority of tegoprazan triple therapy (tegoprazan, amoxicillin, and clarithromycin; hereinafter TAC) to lansoprazole triple therapy (lansoprazole, amoxicillin, and clarithromycin; hereinafter LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan after oral administration of the therapy for 7 days, twice daily in H. pylori positive patients.', 'detailedDescription': 'This is a randomized, double blind, active controlled, multicenter, Phase 3 study to demonstrate the non-inferiority of tegoprazan triple therapy (TAC) to lansoprazole triple therapy (LAC) in terms of H. pylori eradication rate and to evaluate the safety of tegoprazan in H. pylori positive patients after oral administration of therapy for 7 days, twice daily. After the treatment, UBT test will be conducted to confirm the Helicobacter pylori eradication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* H. pylori positive based on the screening test\n* Peptic ulcer disease\n\nExclusion Criteria:\n\n* Prior treatment for H. pylori eradication\n* Prior use of proton pump inhibitors (PPIs), H2 receptor blockers, at a full dosage within 14 days\n* Prior use of H. pylori eradication effective antibiotics, bismuth within 14 days'}, 'identificationModule': {'nctId': 'NCT03498456', 'briefTitle': 'Triple Therapy With Tegoprazan in H. Pylori Positive Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'HK inno.N Corporation'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of a Triple Therapy With Tegoprazan, Amoxicillin, and Clarithromycin in H. Pylori Positive Patients', 'orgStudyIdInfo': {'id': 'CJ_APA_307'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tegoprazan/Amoxicillin/Clarithromycin', 'description': 'Tegoprazan 50 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg', 'interventionNames': ['Drug: Tegoprazan/Amoxicillin/Clarithromycin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lansoprazole/Amoxicillin/Clarithromycin', 'description': 'Lansoprazole 30 mg / Amoxicillin 1000 mg / Clarithromycin 500 mg', 'interventionNames': ['Drug: Lansoprazole/Amoxicillin/Clarithromycin']}], 'interventions': [{'name': 'Tegoprazan/Amoxicillin/Clarithromycin', 'type': 'DRUG', 'otherNames': ['Tegoprazan triple therapy (TAC)'], 'description': 'Tegoprazan 50 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg bid. This therapy will be administered for a total of 7 days, in fasting conditions in the morning and the evening.', 'armGroupLabels': ['Tegoprazan/Amoxicillin/Clarithromycin']}, {'name': 'Lansoprazole/Amoxicillin/Clarithromycin', 'type': 'DRUG', 'otherNames': ['Lansoprazole triple therapy (LAC)'], 'description': 'Lansoprazole 30 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg bid. This therapy will be administered for a total of 7 days, in fasting conditions in the morning and the evening.', 'armGroupLabels': ['Lansoprazole/Amoxicillin/Clarithromycin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hwoon Yong Jung, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HK inno.N Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}