Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-02-12 @ 5:30 PM
Study NCT ID:
NCT02084420
Status:
COMPLETED
Last Update Posted:
2014-06-03
First Post:
2014-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy/Safety Study as H. Pylori Eradication of Triple Therapy for 7 Days Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010437', 'term': 'Peptic Ulcer'}], 'ancestors': [{'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C119615', 'term': 'ilaprazole'}, {'id': 'D000077402', 'term': 'Pantoprazole'}], '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': 323}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-02', 'studyFirstSubmitDate': '2014-03-05', 'studyFirstSubmitQcDate': '2014-03-07', 'lastUpdatePostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the rate of H.pylori eradication', 'timeFrame': 'participants will be followed at 7 weeks (visit 4)'}], 'secondaryOutcomes': [{'measure': 'the rate of Gastric and/or Duodenal ulcer curation', 'timeFrame': 'participants will be followed at 7 weeks (visit 4)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Peptic Ulcer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate of efficacy and safety as H.pylori eradiation effect between Ilaprazole and Pantoprazole triple therapy for 7 days treatment in Gastric and/or Duodenal ulcer patients with H.pylori positive infection.', 'detailedDescription': 'This study is to evaluate of efficacy and safety as H.pylori eradiation effect between Ilaprazole and Pantoprazole triple therapy for 7 days treatment in Gastric and/or Duodenal ulcer patients with H.pylori positive infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 year old ≤ Male or female \\< 75 year old\n* Patients who had endoscopically confirmed Gastric and/or duodenal ulcer and H.pylori infection confirmed by Urea Breath Test\n* Patients who understand the study conditions\n* Patients who had been given the explanation about the study, and had provided voluntary written informed consent to participate in the stud\n\nExclusion Criteria:\n\n* Patients with known allergy or hypersensitivity reaction to the Investigational products\n* Patients who use the Investigational products\n* Patients who undergone H.pylori eradication\n* Patients with abnormal laboratory results, as specified below:\n\nTotal bilirubin, creatinine \\> 1.5 x upper limit of normal Aspartate transminase, Alanine transminase, Alkaline phosphatase, Blood urea nitrogen \\> 2 x upper limit of normal\n\n* Patients who used Proton Pump Inhibitor agents or antibiotics within the last 2 weeks before the start of the Investigational products\n* Pregnant women and lactating women\n* Women of childbearing potential who were not using a medically acceptable method of contraception during the study period.(Menopausal women who did not have a menstrual period for at least 12 months were considered infertile)\n* Patients with uncontrolled Diabetes mellitus\n* Patients with uncontrolled Hypertension\n* Patients with Alcoholics\n* Patients with a history of malignancy within 5 years prior to the study entry (Day 1) (except for basal cell carcinoma of the skin)\n* Patients who had undergone a esophageal or gastric surgery\n* Patients who had a hereditary disorder as galactose intolerance, lactose intolerance, glucose-galactose malabsorption\n* Patients who had participated in other investigational study within 30 days before the study entry (Day 1)\n* Patients who, in the investigator's opinion, are not suitable for the study for any other reason"}, 'identificationModule': {'nctId': 'NCT02084420', 'briefTitle': 'Efficacy/Safety Study as H. Pylori Eradication of Triple Therapy for 7 Days Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Il-Yang Pharm. Co., Ltd.'}, 'officialTitle': 'PhaseⅢ Study of A Multicenter, Randomized, Double-blind, Active-controlled to Evaluate of Efficacy /Safety as H. Pylori Eradication Effect Between Ilaprazole/Pantoprazole', 'orgStudyIdInfo': {'id': 'IY-81149-HB03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ilaprazole or Pantoprazole placebo', 'description': 'Ilaprazole 10mg, Pantoprazole 40mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day, PO', 'interventionNames': ['Drug: Ilaprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ilaprazole placebo or Pantoprazole', 'description': 'Pantoprazole 40mg, Ilaprazole 10mg, Amoxicillin 1000mg, Clarithromycin 500mg 2 times/day,PO', 'interventionNames': ['Drug: Pantoprazole']}], 'interventions': [{'name': 'Ilaprazole', 'type': 'DRUG', 'otherNames': ['NOLTEC'], 'description': '10mg 2 BID( 2 times / day), before breakfast and dinner', 'armGroupLabels': ['Ilaprazole or Pantoprazole placebo']}, {'name': 'Pantoprazole', 'type': 'DRUG', 'otherNames': ['PANTOLOC'], 'description': '40mg, BID(2 times / day), before breakfast and dinner', 'armGroupLabels': ['Ilaprazole placebo or Pantoprazole']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bucheon-si, Gyeonggi-do', 'country': 'South Korea', 'facility': 'Soonchunhang University Hospital'}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Inje Busan Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Busan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daegu', 'country': 'South Korea', 'facility': 'Yeungnam University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'city': 'Daejeon', 'country': 'South Korea', 'facility': 'Konyang University Hospital', 'geoPoint': {'lat': 36.34913, 'lon': 127.38493}}, {'city': 'Incheon', 'country': 'South Korea', 'facility': 'Gachon University Gill Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'city': 'Jeollabuk-do', 'country': 'South Korea', 'facility': 'Wonkwang University of Medicine & Hospital'}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Chung Ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Ewha Womens University Mokdong Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Inje University Seoul Paik Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'KyungHee University Medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul Asan hoapital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'The Catholic University of Korea, Seoul', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Wonju-si, Gangwon-do', 'country': 'South Korea', 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}], 'overallOfficials': [{'name': 'IL YANG PHARM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IL-YANG Pharmaceutical Co.LTD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Il-Yang Pharm. Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}