Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-04-09 @ 9:38 AM
Study NCT ID:
NCT01817556
Status:
COMPLETED
Last Update Posted:
2021-04-15
First Post:
2013-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and of Stillen Tab. and to Demonstrate the Non-inferiority of Stillen Tab.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C116959', 'term': 'DA 9601'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 258}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-13', 'studyFirstSubmitDate': '2013-03-21', 'studyFirstSubmitQcDate': '2013-03-21', 'lastUpdatePostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement rates of erosive gastritis', 'timeFrame': '4 weeks', 'description': 'Improvement rates of erosive gastritis (%)\n\n= (improved cases)/(total cases administered) \\* 100'}], 'secondaryOutcomes': [{'measure': 'Healing rates of erosive gastritis', 'timeFrame': '4 weeks', 'description': 'Healing rates of erosive gastritis (%)\n\n= (healed cases)/(total cases administered)\\*100'}, {'measure': 'Symptoms improved level', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Gastritis', 'Chronic Gastritis']}, 'descriptionModule': {'briefSummary': 'This is a multicenter, active-controlled, randomized, double-blinded, paralleled group clinical study to evaluate the efficacy of 4-week treatment with Stillen tab. in patients with acute or chronic gastritis. Subject will receive Stillen tab or Mucosta tab., three times a day for four weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age is over 20 years old, under 75 years old, men or women\n* Patients diagnosed with acute or chronic gastritis by gastroscopy\n* Patients with one or more erosions found by gastroscopy\n* Signed the informed consent forms\n\nExclusion Criteria:\n\n* Patients with peptic ulcer and gastroesophageal reflux disease\n* Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 2 weeks\n* Patients with surgery related to gastroesophageal\n* Patients with Zollinger-Ellison syndrome\n* Patients with any kind of malignant tumor\n* Patients administered with anti-thrombotic drugs\n* Patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease\n* Women either pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT01817556', 'briefTitle': 'A Study to Evaluate the Efficacy and of Stillen Tab. and to Demonstrate the Non-inferiority of Stillen Tab.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'A Multicenter, Active-controlled, Randomized, Double-blind Paralleled-group Clinical Trial to Evaluate the Efficacy of 4-week Treatment With Stillen Tab. in Patients With Acute or Chronic Gastritis', 'orgStudyIdInfo': {'id': 'DA9601_Gas_IV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stillen Tab.', 'description': 'administered three times daily for four weeks', 'interventionNames': ['Drug: Stillen Tab.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mucosta Tab.', 'description': 'administered three times daily for four weeks', 'interventionNames': ['Drug: Mucosta Tab.']}], 'interventions': [{'name': 'Stillen Tab.', 'type': 'DRUG', 'armGroupLabels': ['Stillen Tab.']}, {'name': 'Mucosta Tab.', 'type': 'DRUG', 'armGroupLabels': ['Mucosta Tab.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University Health System, Severance Hospital, IRB', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yong Chan Lee, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yonsei University, Severance Hospital of Korea'}, {'name': 'Jin Il Kim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The Catholic University, Yeouido St. Mary's Hospital of Korea"}, {'name': 'Kwang Ro Joo, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyung Hee University Gangdong Hospital of Korea'}, {'name': 'Dong Il Park, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kangbuk Samsung Hospital of Korea'}, {'name': 'In Kyung Sung, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Konkuk University Hospital of Korea'}, {'name': 'Kyu Chan Huh, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Konyang University Hospital of Korea'}, {'name': 'Jung Il Suh, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dongguk University Gyeongju Hospital of Korea'}, {'name': 'Su Jin Hong, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soon Chun Hyang University Bucheon Hospital of Korea'}, {'name': 'Jin Heung Kim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University Hospital of Korea'}, {'name': 'Dae Hwan Kang, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pusan National University Yangsan Hospital of Korea'}, {'name': 'Tae Joo Jeon, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inje University Sanggye Paik Hospital of Korea'}, {'name': 'Tea Oh Kim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inje University Haeundae Paik Hospital of Korea'}, {'name': 'Hyun Yong Jeong, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chungnam National Unviersity Hospital of Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}