Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-02-27 @ 1:08 AM
Study NCT ID:
NCT04840550
Status:
UNKNOWN
Last Update Posted:
2023-07-14
First Post:
2021-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064747', 'term': 'Lansoprazole'}, {'id': 'C000631239', 'term': 'tegoprazan'}], '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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 390}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-13', 'studyFirstSubmitDate': '2021-04-07', 'studyFirstSubmitQcDate': '2021-04-07', 'lastUpdatePostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects with gastric and/or duodenal ulcers at Week 24', 'timeFrame': 'week 24', 'description': 'The proportion of subjects with gastric and/or duodenal ulcers on upper GI endoscopy at Week 24'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects without NSAID-related GI symptoms at Weeks 4, 12, and 24', 'timeFrame': 'week 4, 12, 24', 'description': 'GI symptoms are as follows; Heartburn, Regurgitation, Upper abdominal pain or discomfort'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preventive Peptic Ulcer']}, 'descriptionModule': {'briefSummary': 'This study is designed to confirm the non-inferiority of Tegoprazan 25 mg, compared to Lansoprazole 15 mg, to prevent gastroduodenal ulcers and verify the safety of tegoprazan following oral administration of tegoprazan 25 mg QD or lansoprazole 15 mg QD in patients on long-term treatment with NSAIDs.', 'detailedDescription': 'This is a double-blind, randomized, active-controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 25 mg, lansoprazole 15 mg).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥60 years of age, or ≥20 years of age with a history of gastroduodenal ulcers (gastric and/or duodenal ulcers) at screening\n* Requires continued treatment with NSAIDs for ≥24 weeks\n\nExclusion Criteria:\n\n* Has an active stage (A1, A2) or healing stage (H1, H2) of gastroduodenal ulcers per the Sakita-Miwa classification identified by upper GI endoscopy at screening\n* Has uncontrolled severe hypertension\n* Has severe heart failure, congestive heart failure (NYHA Ⅱ to Ⅳ), ischemic heart disease (unstable angina, myocardial infarction), or peripheral artery disease, or has undergone coronary artery bypass graft (CABG) who is considered ineligible for treatment with NSAIDs\n* Has a positive H. pylori test at screening'}, 'identificationModule': {'nctId': 'NCT04840550', 'briefTitle': 'Study to Evaluate the Safety, Efficacy of Tegoprazan for the Prevention of PUD in Patients on Treatment With NSAIDs', 'organization': {'class': 'INDUSTRY', 'fullName': 'HK inno.N Corporation'}, 'officialTitle': 'A Phase 3, Randomized, Double-blind, Active-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Tegoprazan 25 mg for the Prevention of Peptic Ulcer Disease in Patients on Continuous Long-term Treatment With NSAIDs', 'orgStudyIdInfo': {'id': 'IN_APA_308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tegoprazan 25mg', 'description': 'Tegoprazan 25mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.', 'interventionNames': ['Drug: Tegoprazan 25 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lansoprazole 15mg', 'description': 'Lansoprazole 15mg capsules will be orally administered, once a day, with NSAIDs, for up to 6 months.', 'interventionNames': ['Drug: Lansoprazole 15 mg']}], 'interventions': [{'name': 'Lansoprazole 15 mg', 'type': 'DRUG', 'description': 'Lansoprazole 15 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.', 'armGroupLabels': ['Lansoprazole 15mg']}, {'name': 'Tegoprazan 25 mg', 'type': 'DRUG', 'description': 'Tegoprazan 25 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.', 'armGroupLabels': ['Tegoprazan 25mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jae J. Kim', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'JH Oh', 'role': 'CONTACT'}], 'facility': "The catholic univ. of Korea Eunpyeong ST. Mari's hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Yugyeong Park', 'role': 'CONTACT', 'email': 'yugyeong.park@inno-n.com', 'phone': '82-2-6477-0269'}, {'name': 'Jiwon Lee', 'role': 'CONTACT', 'email': 'jiwon.lee@inno-n.com', 'phone': '82-2-6477-0273'}], 'overallOfficials': [{'name': 'Jea Jun Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HK inno.N Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}