Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-01 @ 5:28 AM
Study NCT ID:
NCT02034604
Status:
COMPLETED
Last Update Posted:
2019-12-02
First Post:
2014-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Naftopidil in Patient With Neurogenic Lower Urinary Tract Dysfunction Not Caused by Benign Prostatic Hyperplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077409', 'term': 'Tamsulosin'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 194}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-28', 'studyFirstSubmitDate': '2014-01-09', 'studyFirstSubmitQcDate': '2014-01-10', 'lastUpdatePostDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Changes in patients' symptom questionnaires", 'timeFrame': 'from baseline to 8 weeks of treatment', 'description': 'international prostate symptom score (IPSS) change, except QOL domain scores'}], 'secondaryOutcomes': [{'measure': 'Changes in uroflow parameters', 'timeFrame': 'from baseline to 8 weeks of treatment', 'description': 'maximal flow rate, mean flow rate, voided volume and Changes in uroflowmetry parameters : maximal flow rate,mean flow rate, voided volume and PVR'}, {'measure': 'Change in proportion of patients showed an improvement in IPSS total scores of more than 25%.', 'timeFrame': 'from baseline to 8 weeks of treatment'}, {'measure': 'Benefit, Satisfaction, and Willingness to Continue (BSW) questions', 'timeFrame': '8 weeks after treatment'}, {'measure': 'Score of global response assessment for Korean, GRA-K', 'timeFrame': '8 weeks after treatment'}, {'measure': 'Treatment satisfaction question, TSQ', 'timeFrame': '8 weeks after treatment'}, {'measure': 'safety evaluation : incidence and severity of adverse events', 'timeFrame': 'up to 8 weeks'}, {'measure': 'change in each domain scores of IPSS', 'timeFrame': 'up to 8 weeks'}, {'measure': 'change in number of urinary frequency, nocturia', 'timeFrame': 'up to 8weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Naftopidil', 'safety'], 'conditions': ['Neurogenic Lower Urinary Tract Dysfunction']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate efficacy and safety of naftopidil in patient with neurogenic lower urinary tract dysfunction not caused by benign prostatic hyperplasia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female aged 20 years old and above (upper limit of age: 80 years old)\n2. patients diagnosed as neurogenic bladder due to cerebrovascular accident, parkinson disease, spinal cord lesion, diabetic neuropathy etc)\n3. a+b\n\n 1. IPSS ≥ 12 and QoL ≥ 3\n 2. Maximum Flow Rate \\<15 mL/s (Voiding volume) ≥ 120mL)\n4. Ability and willingness to correctly complete the micturition diary and questionnaire\n5. Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits\n\nExclusion Criteria:\n\n1. In male aged 50 years old and above, bladder outlet obstruction (Bladder Outlet Obstruction Index(BOOI) ≥40)\n2. In female, Pelvic Organ Prolapse ICS stage; POP-Q stage ≥ 2\n3. In female, the history of anti-incontinence operation.\n4. Patients with cancer of any type including cancer of the prostate or bladder\n5. Patients with urethral stricture or bladder neck contracture'}, 'identificationModule': {'nctId': 'NCT02034604', 'briefTitle': 'Efficacy and Safety of Naftopidil in Patient With Neurogenic Lower Urinary Tract Dysfunction Not Caused by Benign Prostatic Hyperplasia', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'orgStudyIdInfo': {'id': '2013-02-043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Naftopidil Group', 'description': 'Naftopidil medication patients', 'interventionNames': ['Drug: Naftofidil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tamsulosin Goup', 'description': 'Tamsulosin medication patients', 'interventionNames': ['Drug: Tamsulosin']}], 'interventions': [{'name': 'Naftofidil', 'type': 'DRUG', 'armGroupLabels': ['Naftopidil Group']}, {'name': 'Tamsulosin', 'type': 'DRUG', 'armGroupLabels': ['Tamsulosin Goup']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor,MD,PhD', 'investigatorFullName': 'KYU-SUNG LEE', 'investigatorAffiliation': 'Samsung Medical Center'}}}}