Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-30 @ 9:23 AM
Study NCT ID:
NCT05282069
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2022-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000630740', 'term': 'DA-8010'}, {'id': 'D000069464', 'term': 'Solifenacin Succinate'}], 'ancestors': [{'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D044005', 'term': 'Tetrahydroisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, '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': 607}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-24', 'studyFirstSubmitDate': '2022-03-07', 'studyFirstSubmitQcDate': '2022-03-07', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the mean number of micturitions per 24 hours at 12 weeks', 'timeFrame': '12 weeks', 'description': 'Change from baseline in the mean number of micturitions per 24 hours at 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in the mean number of micturitions per 24 hours at 4 and 8 weeks', 'timeFrame': '4 and 8 weeks', 'description': 'Change from baseline in the mean number of micturitions per 24 hours at 4 and 8 weeks'}, {'measure': 'Change from baseline in the mean number of urinary urgency(Grade 2, 3, 4) per 24 hours at 4, 8 and 12 weeks', 'timeFrame': '4, 8 and 12 weeks', 'description': 'Change from baseline in the mean number of urinary urgency(Grade 2, 3, 4) per 24 hours at 4, 8 and 12 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overactive Bladder']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of DA-8010 in patients with overactive bladder for 12 weeks as double-blind, placebo-controlled and active-reference study, and also will evaluate the long-term safety of DA-8010 for 52 weeks in patients with overactive bladder as open-label study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMain Inclusion at Screening (Visit 1):\n\n* Men and women 19 years or older with OAB symptoms for ≥ 3 months.\n* Subject who is willing and able to complete the voiding diary correctly.\n* Subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study\n\nExclusion Criteria:\n\nMain Exclusion at Screening (Visit 1):\n\n* Clinically significant stress urinary incontinence or mixed urinary incontinence where stress is the predominant factor\n* Subject who has Injury or neurodegenerative disease which is able to effect on lower urinary tract and nerves\n* Subject with diabetes insipidus, urinary stone, urinary tract infection, interstitial cystitis, recurrent urinary tract infection, pelvic organ prolapse or neurogenic bladder\n* Clinically significant benign prostatic hyperplasia at the discretion of the investigator\n* Had bladder or lower urinary tract surgery within 12 months from the screening visit\n* Medical history of malignant tumor in urinary system or pelvic organs\n* \\>150 mL of post-void residual volume in the screening test'}, 'identificationModule': {'nctId': 'NCT05282069', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'A Multicenter, Double-blind, Placebo-controlled and Active-reference, Randomized, Parallel, Therapeutic Confirmatory Clinical Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder', 'orgStudyIdInfo': {'id': 'DA8010_OAB_III'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'DA-8010 placebo + Solifenacin succinate placebo', 'interventionNames': ['Drug: DA-8010 Placebo', 'Drug: Solifenacin succinate placebo']}, {'type': 'EXPERIMENTAL', 'label': 'DA-8010 2.5mg', 'description': 'DA-8010 2.5mg + Solifenacin succinate placebo', 'interventionNames': ['Drug: DA-8010 2.5mg', 'Drug: Solifenacin succinate placebo']}, {'type': 'EXPERIMENTAL', 'label': 'DA-8010 5mg', 'description': 'DA-8010 5mg + Solifenacin succinate placebo', 'interventionNames': ['Drug: DA-8010 5mg', 'Drug: Solifenacin succinate placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Solifenacin 5mg', 'description': 'DA-8010 placebo + Solifenacin succinate 5mg', 'interventionNames': ['Drug: DA-8010 Placebo', 'Drug: Solifenacin 5mg']}], 'interventions': [{'name': 'DA-8010 Placebo', 'type': 'DRUG', 'description': 'Participants receive placebo to match DA-8010 orally once a day.', 'armGroupLabels': ['Placebo', 'Solifenacin 5mg']}, {'name': 'DA-8010 2.5mg', 'type': 'DRUG', 'description': 'Participants receive DA-8010 2.5mg orally once a day.', 'armGroupLabels': ['DA-8010 2.5mg']}, {'name': 'DA-8010 5mg', 'type': 'DRUG', 'description': 'Participants receive DA-8010 5mg orally once a day.', 'armGroupLabels': ['DA-8010 5mg']}, {'name': 'Solifenacin 5mg', 'type': 'DRUG', 'description': 'Participants receive solifenacin 5 mg orally once a day.', 'armGroupLabels': ['Solifenacin 5mg']}, {'name': 'Solifenacin succinate placebo', 'type': 'DRUG', 'description': 'Participants receive placebo to match solifenacin 5 mg orally once a day.', 'armGroupLabels': ['DA-8010 2.5mg', 'DA-8010 5mg', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}