Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-01-08 @ 6:04 PM
Study NCT ID:
NCT00479505
Status:
COMPLETED
Last Update Posted:
2011-03-23
First Post:
2007-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study The Effects Of Different Doses Of UK-369,003 In Men 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': 'C553931', 'term': '1-(6-ethoxy-5-(3-ethyl-6,7-dihydro-2-(2-methoxyethyl)-7-oxo-2H-pyrazolo(4,3-d)pyrimidin-5-yl)-3-pyridyl sulphonyl)-4-ethylpiperazine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 275}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'dispFirstSubmitDate': '2009-03-24', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-11', 'studyFirstSubmitDate': '2007-05-24', 'dispFirstSubmitQcDate': '2011-03-11', 'studyFirstSubmitQcDate': '2007-05-25', 'dispFirstPostDateStruct': {'date': '2011-03-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-03-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'This is an estimation study with no primary endpoint. There are efficacy endpoints.', 'timeFrame': '12 Weeks'}], 'secondaryOutcomes': [{'measure': 'Patient reported treatment impact questionnaire.', 'timeFrame': '12 Weeks'}, {'measure': 'Lower urinary tract symptoms diary.', 'timeFrame': '12 Weeks'}, {'measure': 'International prostate symptom score questionnaire.', 'timeFrame': '12 Weeks'}, {'measure': 'OAB-q short form questionnaire.', 'timeFrame': '12 Weeks'}, {'measure': 'Patient perception of bladder control questionnaire.', 'timeFrame': '12 Weeks'}, {'measure': 'International index of erectile function questionnaire.', 'timeFrame': '12 Weeks'}, {'measure': 'International consultation on incontinence questionnaire.', 'timeFrame': '12 Weeks'}, {'measure': 'Quality of erection questionnaire.', 'timeFrame': '12 Weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Urinary Bladder, Overactive']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3711047&StudyName=Study%20The%20Effects%20Of%20Different%20Doses%20Of%20UK-369%2C003%20In%20Men%20With%20Overactive%20Bladder.', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a 12 week study in which different doses of UK-369,003 will be administered to patients with a diagnosis of overactive bladder. Patients will complete a series of questionnaires before treatment, during treatment and after treatment, to assess whether UK-369,003 has improved their symptoms of overactive bladder and erectile function.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male subjects aged 18 years and above\n* documented clinical diagnosis of overactive bladder with urinary frequency \\>= 8 times / 24 hours and number of urgency episodes \\> 1 episode / 24 hours.\n\nExclusion Criteria:\n\n* Neurological diseases known to affect bladder function.\n* Urinary tract infection.'}, 'identificationModule': {'nctId': 'NCT00479505', 'briefTitle': 'Study The Effects Of Different Doses Of UK-369,003 In Men With Overactive Bladder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Multi-Center, Randomised, Parallel Group, Double-Blind, Placebo Controlled Estimation Study To Assess The Efficacy And Safety Of Modified Release UK-369,003 In The Treatment Of Men With Storage Lower Urinary Tract Symptoms (LUTS) With And Without Erectile Dysfunction (ED).', 'orgStudyIdInfo': {'id': 'A3711047'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'interventionNames': ['Drug: UK-369,003']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'UK-369,003', 'type': 'DRUG', 'description': 'UK-369,003 100mg, 50mg, 25mg and 10mg doses in addition to placebo.', 'armGroupLabels': ['Active']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2228', 'city': 'Miranda', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -34.03857, 'lon': 151.10005}}, {'zip': '4021', 'city': 'Kippa-Ring', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -27.22586, 'lon': 153.0835}}, {'zip': 'V8T 5G1', 'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'zip': 'L4M 7G1', 'city': 'Barrie', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.40011, 'lon': -79.66634}}, {'zip': 'N2N 2B9', 'city': 'Kitchener', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.42537, 'lon': -80.5112}}, {'zip': 'M6A 3B5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '2820945', 'city': 'Rancagua', 'state': 'Región del Libertador General Bernardo O’Higgins', 'country': 'Chile', 'facility': 'Pfizer 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