Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 9:53 PM
Study NCT ID:
NCT01509261
Status:
COMPLETED
Last Update Posted:
2012-01-12
First Post:
2012-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Ilaprazole to Treat Erosive Esophgitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C119615', 'term': 'ilaprazole'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-10', 'studyFirstSubmitDate': '2012-01-10', 'studyFirstSubmitQcDate': '2012-01-10', 'lastUpdatePostDateStruct': {'date': '2012-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy', 'timeFrame': '8 Weeks', 'description': 'Endoscopic healing of erosive esophagitis is defined as those participants who have endoscopically confirmed EE of Grade O as defined by the Los Angeles (LA) Classification Grading System. The definitions of each grade are: Grade O (No mucosal break), Grade A (Mucosal break \\<5 mm), Grade B (Mucosal break ≥5 mm), Grade C (Mucosal break continuous between two or more folds and \\<75% of the circumference) and Grade D (Mucosal break ≥75% of the circumference).'}], 'secondaryOutcomes': [{'measure': 'The crude healing rate of EE at Week 8 of treatment as assessed by endoscopy', 'timeFrame': '4 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Erosive Esophagitis', 'Ilaprazole', 'GERD'], 'conditions': ['Erosive Esophagitis', 'GERD']}, 'descriptionModule': {'briefSummary': 'This study compared Ilaprazole 20mg with lansoprazole 30mg for the healing of erosive esophagitis and resolution of heartburn.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D) within 14 days prior to baseline.\n* Episodes of heartburn or regurgitation has experienced during the last 7 days prior to baseline.\n\nExclusion Criteria:\n\n* Coexisting diseases affecting the esophagus (eg, eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infection, or esophageal stricture), history of radiation therapy or cryotherapy to the esophagus, caustic or physiochemical trauma such as sclerotherapy to the esophagus. Presence of a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter) or Barrett's esophagus were not exclusionary.\n* Current or a history of Zollinger-Ellison syndrome and other acid hypersecretory conditions, or current gastric or duodenal ulcer.\n* Known hypersensitivity to any PPI (including lansoprazole, omeprazole, rabeprazole, pantoprazole or esomeprazole), any component of ilaprazole, or Gelusil.\n* Cancer (except basal cell carcinoma of the skin) within 5 years prior to screening."}, 'identificationModule': {'nctId': 'NCT01509261', 'briefTitle': 'Efficacy Study of Ilaprazole to Treat Erosive Esophgitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Il-Yang Pharm. Co., Ltd.'}, 'officialTitle': 'A Phase Ⅲ Multi-center, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Ilaprazole (20mg QD) in Adult Patients With Erosive Esophagitis', 'orgStudyIdInfo': {'id': 'IY-81149-EE03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ilaprazole', 'description': 'Ilaprazole 20mg', 'interventionNames': ['Drug: Ilaprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'lansoprazole', 'description': 'lansoprazole 30mg', 'interventionNames': ['Drug: Lansoprazole']}], 'interventions': [{'name': 'Ilaprazole', 'type': 'DRUG', 'otherNames': ['Noltec'], 'description': '20mg/Tap, QD', 'armGroupLabels': ['Ilaprazole']}, {'name': 'Lansoprazole', 'type': 'DRUG', 'description': '30mg/Tap, QD', 'armGroupLabels': ['lansoprazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '133-791', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-720', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '136-705', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '137-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '140-743', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '150-713', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '152-703', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '301-721', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '400-711', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '443-721', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '463-707', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '501-757', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '516-712', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '614-735', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '626-770', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '705-718', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Local Institution', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kim JinHo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Il-Yang Pharm. Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}