Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 6:02 PM
Study NCT ID:
NCT04541134
Status:
UNKNOWN
Last Update Posted:
2020-09-09
First Post:
2020-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients With Primary Dysmenorrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C040375', 'term': 'pelubiprofen'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double-blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-01', 'studyFirstSubmitDate': '2020-09-01', 'studyFirstSubmitQcDate': '2020-09-01', 'lastUpdatePostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TOTPAR-8', 'timeFrame': 'Day 1', 'description': 'Time weighted sum of total pain relief'}, {'measure': 'SPID-8', 'timeFrame': 'Day 1', 'description': 'Sum of pain intensity difference'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Primary Dysmenorrhea']}, 'descriptionModule': {'briefSummary': 'A Multi-center, Randomized, Placebo-controlled, Double-blind, Cross-over, Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients with Primary Dysmenorrhea'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients, age between 19 years to 44years\n* Patients with menstrual pain over 4 out of 6 menstrual cycles before screening\n* Patients with moderate or severe menstrual pain for recent 2 menstrual cycles\n* Patients with regular menstrual cycles(28±7 days) for a year\n\nExclusion Criteria:\n\n* Patients diagnosed or suspected of secondary dysmenorrhea\n* Previous adverse reaction or known allergy to NSAIDs\n* Breast feeding woman\n* Patients who are not willing to use proper contraception during clinical trial period'}, 'identificationModule': {'nctId': 'NCT04541134', 'briefTitle': 'Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients With Primary Dysmenorrhea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewon Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multi-center, Randomized, Placebo-controlled, Double-blind, Cross-over, Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients With Primary Dysmenorrhea', 'orgStudyIdInfo': {'id': 'DW9801-303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group 1', 'interventionNames': ['Drug: Pelubiprofen 45mg', 'Drug: Placebo']}, {'type': 'OTHER', 'label': 'Group 2', 'interventionNames': ['Drug: Pelubiprofen 45mg', 'Drug: Placebo']}], 'interventions': [{'name': 'Pelubiprofen 45mg', 'type': 'DRUG', 'description': 'Pelubiprofen 45mg 1 tab for moderate or severe menstrual pain, bid for 3days(prn)', 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo1 tab for moderate or severe menstrual pain, bid for 3days(prn)', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewon Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}