Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2025-12-29 @ 7:55 PM
Study NCT ID:
NCT05683951
Status:
COMPLETED
Last Update Posted:
2023-01-13
First Post:
2022-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Evaluate the Efficacy and Safety of DWKH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, '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': 186}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-04', 'studyFirstSubmitDate': '2022-05-30', 'studyFirstSubmitQcDate': '2023-01-04', 'lastUpdatePostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bronchitis severity score (BSS)', 'timeFrame': '0,4,7 days', 'description': 'Difference of the BSS score (0 to 4, higher score means more severe)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Infection']}, 'descriptionModule': {'briefSummary': 'Randomized, Double-blind, Parellel, Multicenter, Active-controlled'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female aged between 19 and 80.\n* Patients whose BSS score is over 5.\n\nExclusion Criteria:\n\n* Patients allergic to any ingredients of the study drugs.\n* Moderate liver disease (ALT or AST \\> UNLx3).\n* Moderate lung disease.\n* Uncontrolled HTN.\n* Uncontrolled DM.\n* Uncontrolled thyroidism.\n* Patients who is needed antibiotics during the study period.\n* In the case of women, pregnant(Urine-HCG positive) or lactating women.'}, 'identificationModule': {'nctId': 'NCT05683951', 'briefTitle': 'Clinical Trial to Evaluate the Efficacy and Safety of DWKH', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewon Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWKH', 'orgStudyIdInfo': {'id': 'DWKH-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DWKH', 'interventionNames': ['Drug: DWKH']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DWKH-R', 'interventionNames': ['Drug: DWKH-R']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'DWKH', 'type': 'DRUG', 'description': 'Administration of DWKH three times daily', 'armGroupLabels': ['DWKH']}, {'name': 'DWKH-R', 'type': 'DRUG', 'description': 'Administration of DWKH-R three times daily', 'armGroupLabels': ['DWKH-R']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administration of Placebo three times daily', 'armGroupLabels': ['PLACEBO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08308', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Guro Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewon Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}