Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-01-25 @ 7:39 PM
Study NCT ID:
NCT06894992
Status:
RECRUITING
Last Update Posted:
2025-05-29
First Post:
2025-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tegoprazan And Lansoprazole Effectiveness in Bleeding Peptic Ulcer Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010438', 'term': 'Peptic Ulcer Hemorrhage'}, {'id': 'D010437', 'term': 'Peptic Ulcer'}], 'ancestors': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000631239', 'term': 'tegoprazan'}, {'id': 'D064747', 'term': 'Lansoprazole'}, {'id': 'D054328', 'term': 'Proton Pump Inhibitors'}], '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'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 162}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-23', 'studyFirstSubmitDate': '2025-03-19', 'studyFirstSubmitQcDate': '2025-03-19', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healing Rate', 'timeFrame': '2 weeks', 'description': 'The healing rate will be rated using Forrest Classification'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tegoprazan', 'Lansoprazole', 'Peptic Ulcer', 'Peptic Ulcer Bleeding', 'Healing Rate'], 'conditions': ['Peptic Ulcer Bleeding']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the effects of tegoprazan vs lansoprazole in healing bleeding peptic ulcers. It will also teach about the safety of both modalities. The main questions it aims to answer are:\n\nHow does the effectiveness of Tegoprazan compare with Lansoprazole in two weeks of healing rate bleeding peptic ulcer patients in the Indonesian population?\n\nResearchers will compare the drug tegoprazan to lansoprazole with a double-blind randomized control to see their effect on healing bleeding peptic ulcers.\n\nParticipants will:\n\nTake drug tegoprazan 50 mg OD or lansoprazole 30 mg OD every day for 2 weeks Endoscopic examination at the beginning before treatment and after completion of treatment within 2 weeks Record of their adverse effect occurrence', 'detailedDescription': 'Peptic ulcer disease (PUD) is a condition characterized by disruption of the gastric and duodenal mucosal lining due to exposure to gastric acid or pepsin. Major causes include Helicobacter pylori infection, nonsteroidal anti-inflammatory drug (NSAID) use, gastric bypass surgery, lifestyle factors such as smoking and alcohol consumption, and genetic predisposition. PUD affects 5-10% of the global population and poses a significant healthcare burden, with prevalence rising from 6.43 million to 8.09 million cases between 1990 and 2019.\n\nCurrent PUD treatment involves acid-suppressing agents and H. pylori eradication when indicated. Proton pump inhibitors (PPIs) play a key role by irreversibly inhibiting H⁺/K⁺ ATPase in gastric parietal cells, effectively maintaining gastric pH ≥4, which is essential for ulcer healing and preventing complications like bleeding. Lansoprazole, a widely used PPI, has demonstrated strong efficacy, with healing rates of 64%, 75.6%, and 95.7% at 2, 4, and 8 weeks, respectively. However, PPIs have limitations, including short plasma half-life, food dependency, breakthrough symptoms, and potential long-term adverse effects such as hypergastrinemia, acid rebound, and gut microbiota alterations.\n\nTo overcome these limitations, potassium-competitive acid blockers (PCABs) like vonoprazan and tegoprazan have been developed. PCABs provide faster, more stable, and potent acid suppression compared to PPIs. Unlike PPIs, which require activation in an acidic environment, PCABs directly inhibit H⁺/K⁺ ATPase by competitively binding to potassium sites, offering more predictable pharmacokinetics. Tegoprazan, a newer PCAB, has demonstrated superior acid suppression and a faster onset of action than vonoprazan, making it highly relevant for ulcer healing and preventing nocturnal acid breakthrough.\n\nStudies suggest that PCABs are non-inferior to PPIs in treating PUD, with some data indicating that tegoprazan offers stronger, faster, and more stable acid suppression than vonoprazan. However, no studies have compared the healing rates of tegoprazan and lansoprazole specifically in bleeding PUD patients over a 2-week treatment period. Given the importance of optimizing treatment for bleeding PUD in Indonesia, this study aims to compare the effectiveness of tegoprazan and lansoprazole in ulcer healing over a short-term evaluation period.\n\nThis research is expected to contribute to the scientific literature by providing clinical trial data specific to the Indonesian population, inform clinical decision-making by identifying the most effective treatment for bleeding PUD, and ultimately improve patient outcomes by ensuring faster healing and better symptom management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects diagnosed with upper gastrointestinal bleeding caused by peptic ulcer through gastroscopic examination\n\nExclusion Criteria:\n\n* Allergic to Tegoprazan or Lansoprazole\n* Diagnosed with gastric or duodenal cancer, pregnant\n* History of H. pylori infection treatment failure\n* Presence of comorbidities such as chronic kidney disease or decompensated liver cirrhosis\n* Alcohol consumption\n* Undergoing chemotherapy'}, 'identificationModule': {'nctId': 'NCT06894992', 'acronym': 'TALENT', 'briefTitle': 'Tegoprazan And Lansoprazole Effectiveness in Bleeding Peptic Ulcer Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Dr Cipto Mangunkusumo General Hospital'}, 'officialTitle': 'A Comparison of The Effectiveness of Tegoprazan and Lansoprazole in Achieving Cure Rates in Patients With Bleeding Peptic Ulcers: A Double-Blind Randomized Trial', 'orgStudyIdInfo': {'id': '24-12-1819'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Potassium Channel Acid Blocker', 'description': 'Each randomized patients will consume Tegoprazan 50 mg tab PO OD for 2 weeks', 'interventionNames': ['Drug: Tegoprazan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Proton Pump Inhibitor', 'description': 'Each randomized patients will consume Lansoprazole 30 mg tab PO OD for 2 weeks', 'interventionNames': ['Drug: Lansoprazole']}], 'interventions': [{'name': 'Tegoprazan', 'type': 'DRUG', 'otherNames': ['Potassium Channel Acid Blocker', 'PCAB'], 'description': 'Tegoprazan 50 mg tab PO OD in 2 weeks', 'armGroupLabels': ['Potassium Channel Acid Blocker']}, {'name': 'Lansoprazole', 'type': 'DRUG', 'otherNames': ['Proton Pump Inhibitor', 'PPI'], 'description': 'Lansoprazole 30 mg tab PO OD in 2 weeks', 'armGroupLabels': ['Proton Pump Inhibitor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Achmad Fauzi, MD', 'role': 'CONTACT', 'email': 'ppfauzidrgm@gmail.com', 'phone': '+6281386668655'}], 'facility': 'Cipto Mangunkusumo National General Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}, {'zip': '14440', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Mario Steffanus MD', 'role': 'CONTACT', 'email': 'mario.steffanus@atmajaya.ac.id', 'phone': '+6281288002263'}], 'facility': 'Atma Jaya Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'centralContacts': [{'name': 'Mario Steffanus MD', 'role': 'CONTACT', 'email': 'mario.steffanus@atmajaya.ac.id', 'phone': '+6281288002263'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mario Steffanus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dr Cipto Mangunkusumo General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Gastroenterology and Hepatology Division Trainee', 'investigatorFullName': 'Mario Steffanus', 'investigatorAffiliation': 'Dr Cipto Mangunkusumo General Hospital'}}}}