Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-26 @ 10:56 PM
Study NCT ID:
NCT05163756
Status:
COMPLETED
Last Update Posted:
2021-12-20
First Post:
2021-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Efficacy and Safety of DW1903 in Acute and Chronic Gastritis Patient
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double (Participant, Investigator) Double-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 332}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-07', 'studyFirstSubmitDate': '2021-12-07', 'studyFirstSubmitQcDate': '2021-12-07', 'lastUpdatePostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The efficacy rate on gastroscopy', 'timeFrame': 'Week 0, Week2', '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': 'Week 0, Week2', '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': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastritis Acute', 'Gastritis Chronic']}, 'referencesModule': {'references': [{'pmid': '37309193', 'type': 'DERIVED', 'citation': 'Kim JH, Jung HY, Yoo IK, Park SY, Kim JG, Sung JK, Jang JS, Cheon GJ, Kim KO, Kim TO, Lee ST, Cho KB, Chun HJ, Park JJ, Park MI, Jang JY, Jeon SW, Cho JW, Kang DH, Kim GH, Kim JJ, Kim SG, Kim N, Lee YC, Hong SJ, Kim HS, Lee S, Lee SW. Evaluation of the Efficacy and Safety of DW1903 in Patients with Gastritis: A Randomized, Double-Blind, Noninferiority, Multicenter, Phase 3 study. Gut Liver. 2024 Jan 15;18(1):70-76. doi: 10.5009/gnl220446. Epub 2023 Jun 13.'}]}, 'descriptionModule': {'briefSummary': 'A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1903 in Patients with 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.\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': 'NCT05163756', 'briefTitle': 'To Evaluate the Efficacy and Safety of DW1903 in Acute and Chronic Gastritis Patient', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewon Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multi-center, Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DW1903 in Patients With Gastritis', 'orgStudyIdInfo': {'id': 'DW1903-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DW1903(Test)', 'description': 'once a day, q.d. PO / DW1903 + Placebo of DW1903-R1', 'interventionNames': ['Drug: DW1903']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DW1903-R1(Reference)', 'description': 'once a day, q.d. PO / Placebo of DW1903 + DW1903-R1', 'interventionNames': ['Drug: DW1903-R1']}], 'interventions': [{'name': 'DW1903', 'type': 'DRUG', 'description': 'q.d. PO, DW1903 + Placebo of DW1903-R1', 'armGroupLabels': ['DW1903(Test)']}, {'name': 'DW1903-R1', 'type': 'DRUG', 'description': 'q.d. PO, Placebo of DW1903 + DW1903-R1', 'armGroupLabels': ['DW1903-R1(Reference)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02841', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan for IPD.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewon Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}