Study of 2 Doses of Solifenacin Succinate in Female Subjects With Overactive Bladder.
NCT ID: NCT01093534
Last Updated: 2024-12-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
547 participants
INTERVENTIONAL
2010-01-19
2011-06-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Placebo
Participants received 2 placebo tablets once daily for 12 weeks.
Placebo
Matching solifenacin placebo tablet
Solifenacin 5 mg
Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
Placebo
Matching solifenacin placebo tablet
solifenacin
Tablet for oral administration
Solifenacin 10 mg
Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
solifenacin
Tablet for oral administration
Interventions
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Placebo
Matching solifenacin placebo tablet
solifenacin
Tablet for oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Urodynamic diagnosis of detrusor overactivity (DO)
* Either naïve to anti-muscarinic treatment (i.e. no prior history of use of anti-muscarinic agents) or 6-months anti-muscarinic treatment free (i.e. have had no anti-muscarinic treatment within 6 months) prior to the screening visit
* Bladder post-void residual volume of less than 30 ml
* Available to complete the study
Exclusion Criteria
* History, signs or symptoms suggestive of urinary tract infection (confirmed by positive urine analysis), obstruction or urogenital pro-lapse (greater than grade II)
* History of urinary tract operation within 6 months prior to screening
* Indwelling catheter or permanent catheter fitted
* History of pelvic area radiotherapy treatment
* Uncontrolled diabetes mellitus
* History of fibromyalgia
* Post-partum or breast-feeding within 3 months prior to screening visit
* Either pregnant or intends to become pregnant during the study or sexually active, of childbearing potential and is unwilling to utilize a reliable method of birth control (note: reliable methods are contraceptive pills of combination type, hormonal implants or injectable contraceptives)
* Positive pre-study hepatitis B surface antigen, hepatitis C antibody or human immunodeficiency virus (HIV) result at time of screening
* History of drug and / or alcohol abuse at time of screening
* History of urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony or toxic megacolon or severe ulcerative colitis), myasthenia gravis, uncontrolled narrow angle glaucoma or shallow anterior chamber or deemed to be at risk for these conditions
* Undergoing hemodialysis or has severe renal impairment or moderate hepatic impairment or who are on treatment with a potent cytochrome p450 (CYP) 3A4 inhibitor, e.g. Ketoconazole
* Currently dosing with medication(s) intended to treat overactive bladder symptoms or has a history of non-drug treatment, such as electrical therapy, magnetic field stimulation, pelvic floor treatment or bladder training intended to treat overactive bladder symptoms within 6 months prior to screening, as described in the list of prohibited medications
* Currently receiving or has a history of treatment with alpha blockers, botulinum toxin (cosmetic use is acceptable), resiniferatoxin or pelvic floor muscle relaxants within 9 months prior to screening
* Participated in any clinical study less than or equal to 3 months prior to screening
18 Years
FEMALE
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Europe B.V.
Locations
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New York, New York, United States
New York, New York, United States
West Reading, Pennsylvania, United States
Graz, , Austria
Linz, , Austria
Linz, , Austria
Edegem, , Belgium
Ghent, , Belgium
Kortrijk, , Belgium
Sofia, , Bulgaria
Sofia, , Bulgaria
Varba, , Bulgaria
Victoria, British Columbia, Canada
Victoria, British Columbia, Canada
Barrie, Ontario, Canada
Brampton, Ontario, Canada
Brantford, Ontario, Canada
Kitchener, Ontario, Canada
Toronto, Ontario, Canada
Sherbrooke, Quebec, Canada
Brno, , Czechia
Hradec Králové, , Czechia
Podolí, , Czechia
Marseille, , France
Paris, , France
Aachen, , Germany
Berlin, , Germany
Hanover, , Germany
Munich, , Germany
Budapest, , Hungary
Budapest, , Hungary
Szeged, , Hungary
Székesfehérvár, , Hungary
Haifa, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Avellino, , Italy
Milan, , Italy
Milan, , Italy
Rome, , Italy
Varese, , Italy
Arendal, , Norway
Drammen, , Norway
Haugesund, , Norway
Tønsberg, , Norway
Bydgoszcz, , Poland
Krakow, , Poland
Warsaw, , Poland
Warsaw, , Poland
Warsaw, , Poland
Warsaw, , Poland
Timișoara, , Romania
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Saint Peterburg, , Russia
Saint Peterburg, , Russia
Yaroslavl, , Russia
Bardejov, , Slovakia
Martin, , Slovakia
Žilina, , Slovakia
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Lund, , Sweden
Stockholm, , Sweden
Ankara, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Kocaeli, , Turkey (Türkiye)
Harrow, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Countries
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References
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Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
Related Links
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Link to results on Astellas Clinical Study Results website
Other Identifiers
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2008-005215-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
905-EC-007
Identifier Type: -
Identifier Source: org_study_id