Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT03443804
Status:
COMPLETED
Last Update Posted:
2018-02-28
First Post:
2018-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Evaluate the Efficacy and Safety of DW-1401 in Acute and Chronic Gastritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': 462}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-26', 'studyFirstSubmitDate': '2018-02-11', 'studyFirstSubmitQcDate': '2018-02-22', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The efficacy rate on gastroscopy', 'timeFrame': '0, week 2', 'description': 'The efficacy rate is obtained from the following formula using the subject whose erroneous score is improved by 50% or more as compared with before the study drug administration.\n\nThe efficacy rate(%) = (number of effective cases)/(all cases) x 100\n\nEffective case is determined by the grade change of erosion. A case in which the grade changes from 4 to 2 or 1, from 3 to 1, or from 2 to 1 is judged as an effective case.'}], 'secondaryOutcomes': [{'measure': 'Cure rate on gastroscopy', 'timeFrame': '0, week 2', 'description': 'Judging from the gastroscopic examination as normal (no erosion), the cure rate is obtained as follows.\n\nCure rate(%) = (number of cures(no erosion))/(all cases) x 100'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastritis Acute', 'Gastritis Chronic']}, 'descriptionModule': {'briefSummary': 'Evaluate the Efficacy and Safety of DW1401 versus Stillen tab. in Patients with Acute or Chronic Gastritis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who were diagnosed with acute or chronic gastritis in a gastroscopy performed within 7 days prior to administration of this trial.\n* At least one or more erosions have been identified on gastroscopy.\n* Patients who decided to voluntarily participate in this trial and agreed in writing.\n\nExclusion Criteria:\n\n* Patients who can not undergo gastroscopy\n* Peptic ulcer (except scarring) and reflux esophagitis\n* Patients who have had gastric acid suppression surgery or stomach/esophagus surgery (except for simple perforation surgery and appendectomy)\n* Patients with a history of gastrointestinal malignancies\n* Zollinger-Ellison syndrome patients\n* Patient with spontaneous coagulation disorder\n* Patients with an allergic or hypersensitive response to a study drug\n* Patients with a potential pregnancy.\n* Patients who had clinically significant abnormalities in the screening test. (ALT, AST, BUN, Serum creatinine is more than twice the upper limit)\n* Pregnant and lactating women\n* Those currently taking other study drugs\n* patients who were judged to be ineligible for the trial by the principle investigator and the person in charge.'}, 'identificationModule': {'nctId': 'NCT03443804', 'acronym': '2', 'briefTitle': 'To Evaluate the Efficacy and Safety of DW-1401 in Acute and Chronic Gastritis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewon Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase 3 Clinical Trial to Evaluated the Efficacy and Safety of DW-1401 in Acute and Chronic Gastritis Patients', 'orgStudyIdInfo': {'id': 'DW1401-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test(DW1401)', 'description': 'tid PO, DW1401+Placebo of Stillen tab.', 'interventionNames': ['Drug: Test(DW1401)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reference(Stillen tab.)', 'description': 'tid PO, Stillen tab.+Placebo of DW1401', 'interventionNames': ['Drug: Reference(Stillen tab.)']}], 'interventions': [{'name': 'Test(DW1401)', 'type': 'DRUG', 'description': 'DW1401+Placebo of Stillen tab.', 'armGroupLabels': ['Test(DW1401)']}, {'name': 'Reference(Stillen tab.)', 'type': 'DRUG', 'description': 'Stillen tab.+Placebo of DW1401', 'armGroupLabels': ['Reference(Stillen tab.)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan for IPD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewon Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}