Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 4:59 AM
Study NCT ID:
NCT07398261
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-09
First Post:
2023-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Mirabegron for Treatment of Non-monosymptomatic Nocturnal Enuresis in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'C520025', 'term': 'mirabegron'}, {'id': 'C000608232', 'term': 'N-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamide'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-12-11', 'size': 212359, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2026-01-28T18:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 151}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-04', 'studyFirstSubmitDate': '2023-08-29', 'studyFirstSubmitQcDate': '2026-02-04', 'lastUpdatePostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Partial or complete response', 'timeFrame': '18 months'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Treatment of Non-monosymptomatic Nocturnal Enuresis']}, 'descriptionModule': {'briefSummary': 'This phase 3 clinical trial will compare use of individual treatment with mirabegron or desmopressin and their combination for treatment of non-monosymptomatic nocturnal enuresis in children'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Non-monosymptomatic nocturnal enuresis\n\nExclusion Criteria:\n\n* monosymptomatic nocturnal enuresis'}, 'identificationModule': {'nctId': 'NCT07398261', 'briefTitle': 'Efficacy of Mirabegron for Treatment of Non-monosymptomatic Nocturnal Enuresis in Children', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'Efficacy of Mirabegron for Treatment of Non-monosymptomatic Nocturnal Enuresis in Children', 'orgStudyIdInfo': {'id': 'Urol9/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mirabegron 25 mg', 'description': 'Patients received mirabegron 25 mg orally', 'interventionNames': ['Drug: Mirabegron 25 MG']}, {'type': 'NO_INTERVENTION', 'label': 'no intervention', 'description': 'no intervention'}], 'interventions': [{'name': 'Mirabegron 25 MG', 'type': 'DRUG', 'otherNames': ['vibegron'], 'description': 'Evaluate the efficacy of individual mirabegron or in combination for treatment of non-monosymptomatic nocturnal enuresis in children', 'armGroupLabels': ['Mirabegron 25 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32616', 'city': 'Shibīn al Kawm', 'state': 'Monufia Governorate', 'country': 'Egypt', 'facility': 'Menoufia faculty of medicine', 'geoPoint': {'lat': 30.55258, 'lon': 31.00904}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of urology', 'investigatorFullName': 'Mohammed Ali abdelghaffar', 'investigatorAffiliation': 'Menoufia University'}}}}