Ignite Creation Date:
2025-12-24 @ 3:58 PM
Ignite Modification Date:
2025-12-27 @ 11:55 AM
Study NCT ID:
NCT00439192
Status:
TERMINATED
Last Update Posted:
2007-08-08
First Post:
2007-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ELB245 for 12 Weeks Versus 4mg Tolterodine in Patients With Incontinent Overactive Bladder (OAB)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}], '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'}, {'id': 'D014555', 'term': 'Urination Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068737', 'term': 'Tolterodine Tartrate'}], 'ancestors': [{'id': 'D010665', 'term': 'Phenylpropanolamine'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D003408', 'term': 'Cresols'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 275}}, 'statusModule': {'whyStopped': 'side effect profile did not match expectations', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-08-07', 'studyFirstSubmitDate': '2007-02-22', 'studyFirstSubmitQcDate': '2007-02-22', 'lastUpdatePostDateStruct': {'date': '2007-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean number of micturitions'}], 'secondaryOutcomes': [{'measure': 'OAB related measures'}, {'measure': 'urgency measures'}, {'measure': 'Quality of life'}]}, 'conditionsModule': {'keywords': ['OAB, proof of concept', 'Overactive Bladder (OAB)', 'with incontinence'], 'conditions': ['Overactive Bladder', 'Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '34988092', 'type': 'DERIVED', 'citation': 'Song T, Hayanga J, Durham L, Garrison L, McCarthy P, Barksdale A, Smith D, Bartlett R, Jaros M, Nelson P, Molnar Z, Deliargyris E, Moazami N. CytoSorb Therapy in COVID-19 (CTC) Patients Requiring Extracorporeal Membrane Oxygenation: A Multicenter, Retrospective Registry. Front Med (Lausanne). 2021 Dec 20;8:773461. doi: 10.3389/fmed.2021.773461. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to determine the efficacy of escalating doses of ELB245 versus placebo , when administered to patients with OAB and to compare the efficacy of escalating doses of ELB245 versus the standard treatment tolterodine, when administered to patients with OAB.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female outpatients at least 18 years of age\n* Symptoms of OAB for a minimum of 3 consecutive months prior to study entry; severity of OAB (as defined by patient reported symptoms) for a minimum of one month prior to study entry\n* Ability to use a toilet independently and without difficulty\n* No treatment with any medication against OAB during the 4 weeks prior to study entry\n* Written informed consent\n\nExclusion Criteria:\n\n* Breastfeeding women, pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and not practicing a highly reliable method of birth control\n* Any local pathology, that might cause the bladder symptoms\n* Significant stress urinary incontinence or mixed stress/urgency incontinence\n* Any neurological disease affecting bladder function or muscle strength\n* Patient history of any lower urinary tract surgery or previous pelvic irradiation\n* Local administration of botulinum toxin within the last 9 months in the lower urinary tract\n* Start or change of a behavioral bladder training program\n* Post voiding residual volumes larger than 250ml or symptoms of clinically relevant bladder outlet obstruction\n* Nocturial polyuria\n* History of liver disease and/or impaired liver function\n* Cholestasis\n* Chronic alcohol or drug abuse\n* Evidence of significantly impaired renal function (\n* Diabetes mellitus (type I or II) with significant peripheral neuropathy and/or polyuria\n* Inflammatory bowel disease such as Crohn's disease, or ulcerative colitis\n* Uncontrolled narrow angle glaucoma\n* Chronic use of carbamazepine or paracetamol\n* Participation in any drug study in the preceding 3 months\n* Concomitant treatment with strong CYP3A4 inhibitors\n* History or evidence of relevant cardiovascular or cerebrovascular disorders"}, 'identificationModule': {'nctId': 'NCT00439192', 'briefTitle': 'ELB245 for 12 Weeks Versus 4mg Tolterodine in Patients With Incontinent Overactive Bladder (OAB)', 'organization': {'class': 'INDUSTRY', 'fullName': 'elbion AG'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Parallel Group, Phase II, Forced Dose Titration Study to Investigate the Efficacy and Safety of 400mg and 600mg ELB245 Given Once Daily for 12 Weeks (8 + 4 Weeks) Versus Placebo and Versus 4mg Tolterodine Given Once Daily in Patients With Incontinent Overactive Bladder (OAB)', 'orgStudyIdInfo': {'id': 'ELB245201-06'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ELB245', 'type': 'DRUG'}, {'name': 'Tolterodine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55232', 'city': 'Alzey', 'country': 'Germany', 'facility': 'Private Gynecological Practice', 'geoPoint': {'lat': 49.74657, 'lon': 8.11513}}, {'zip': '12247', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Private Urologic Practice', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13057', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Private Urologic Practice', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '46325', 'city': 'Borken', 'country': 'Germany', 'facility': 'Private Urologic Practice', 'geoPoint': {'lat': 51.84382, 'lon': 6.85774}}, {'zip': '47051', 'city': 'Duisburg', 'country': 'Germany', 'facility': 'Private Urologic Practice', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'zip': '47179', 'city': 'Duisburg', 'country': 'Germany', 'facility': 'Private Urologic Practice', 'geoPoint': {'lat': 51.43247, 'lon': 6.76516}}, {'zip': '45355', 'city': 'Essen', 'country': 'Germany', 'facility': 'Private Urologic Practice', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '17493', 'city': 'Greifswald', 'country': 'Germany', 'facility': 'Private Urologic Practice', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'zip': '20097', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Private Urologic Practice', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '20249', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Private Urologic Practice', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '66424', 'city': 'Homburg Saar', 'country': 'Germany', 'facility': 'Private Urologic Practice'}, {'zip': '66271', 'city': 'Kleinblittersdorf', 'country': 'Germany', 'facility': 'Private Urologic Practice', 'geoPoint': {'lat': 49.1578, 'lon': 7.03734}}, {'zip': '35037', 'city': 'Marburg', 'country': 'Germany', 'facility': 'Private Urologic Practice', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'zip': '81925', 'city': 'Munich', 'country': 'Germany', 'facility': 'Private Urologic Practice', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '75417', 'city': 'Mühlacker', 'country': 'Germany', 'facility': 'Private Urologic Practice', 'geoPoint': {'lat': 48.94754, 'lon': 8.83675}}, {'zip': '45468', 'city': 'Mülheim', 'country': 'Germany', 'facility': 'Private Urologic Practice', 'geoPoint': {'lat': 51.43218, 'lon': 6.87967}}, {'zip': '61440', 'city': 'Oberursel', 'country': 'Germany', 'facility': 'Private Urologic Practice', 'geoPoint': {'lat': 50.20731, 'lon': 8.57747}}, {'zip': '70372', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Private Urologic Practice', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '15-337', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'NZOZ Centrum Medyczne dr n. med. Artur Racewicz', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '41-500', 'city': 'Chorzów', 'country': 'Poland', 'facility': 'Urovita Sp z o.o.', 'geoPoint': {'lat': 50.30582, 'lon': 18.9742}}, {'zip': '80-850', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Invicta Sp z o.o.', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '83-400', 'city': 'Kościerzyna', 'country': 'Poland', 'facility': 'Szpital Specjalistyczny w Koscierzynie, Dep. Oddzial Urologii', 'geoPoint': {'lat': 54.12226, 'lon': 17.98119}}, {'zip': '99-300', 'city': 'Kutno', 'country': 'Poland', 'facility': 'NZOZ Specjalista Sp. z o.o.', 'geoPoint': {'lat': 52.23064, 'lon': 19.36409}}, {'zip': '87-100', 'city': 'Torun', 'country': 'Poland', 'facility': 'NZOZ Nasz Lekarz, Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna', 'geoPoint': {'lat': 53.01375, 'lon': 18.59814}}, {'zip': '02-005', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Szpital Kliniczny - Centrum Leczenia Obrazen "Dzieciatka Jezus"', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-777', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Centrum Leczenia Chorob Cywilizacyjnych Andrzej Opadczuk', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '54-144', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'EMC Instytut Medyczny S.A., EuroMediCare, Szpital Specjalistyczny z Przychodnia', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '581 85', 'city': 'Linköping', 'country': 'Sweden', 'facility': 'University Hospital Linköping', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'zip': '141 86', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska University Hospital Huddinge', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '182 88', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Danderyds Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '751 85', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'University Hospital Uppsala', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Martin Michel, Prof.', 'role': 'STUDY_CHAIR', 'affiliation': 'Dept. Pharmacology & Pharmacotherapy, AMC, University of Amsterdam'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'elbion AG', 'class': 'INDUSTRY'}}}}