Solifenacin Succinate Versus Tolterodine 4mg Once Daily
NCT ID: NCT00802373
Last Updated: 2014-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1355 participants
INTERVENTIONAL
2003-07-31
2004-10-31
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
TREATMENT
DOUBLE
Study Groups
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I
Solifenacin succinate 5/10mg
Solifenacin succinate
oral
II
Tolterodine 4mg
Tolterodine
Oral
Interventions
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Solifenacin succinate
oral
Tolterodine
Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient is willing and able to complete the micturition diary correctly
* Symptoms of overactive bladder (including urinary frequency, urgency or urge incontinence) for \>= 3 months
At randomization:
* Patient must experience frequency of micturition on average \>= 8 times per 24 hour period during the 3 day micturition diary period
* Patient must experience at least one of the following symptoms during the 3 day micturition diary period:
* At least 3 episodes of urinary incontinence or,
* Patients must exhibit urgency at least 3 times
Exclusion Criteria
* Pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and practising an unreliable method of birth control or will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type, hormonal implants and injectable contraceptives
* Clinically significant outflow obstruction (at the discretion of the investigator)
* Significant post void residual volume (PVR\>200ml)
* Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator
* Patient with a neurological cause for abnormal detrusor activity
* Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
* Uncontrolled narrow angle glaucoma, urinary or gastric retention or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contra-indicated
* Non drug treatment including electrostimulation therapy or start of a bladder training program during the 2 weeks prior to entry into, or during the study
* Use of drugs intended to treat urinary incontinence
* Diabetic neuropathy
* Known or suspected hypersensitivity to solifenacin, tolterodine, other anticholinergics or lactose
* Any clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the trial
* Participation in any clinical trial within 30 (90 in the UK) days prior to randomisation
* Employees of the Yamanouchi Group, third parties associated with the study, or the study site
At randomization:
* Patient who did not complete the micturition diary according to the instructions
* Total daily urine volume \> 3000 ml as verified in the micturition diary
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Central Contact
Role: STUDY_CHAIR
Astellas Pharma Europe B.V.
Locations
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Minsk, , Belarus
Antwerp, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Middleheim, , Belgium
Brno, , Czechia
Bulovce, , Czechia
České Budějovice, , Czechia
Mělník, , Czechia
Prague, , Czechia
Aalborg, , Denmark
Aarhus, , Denmark
Copenhagen, , Denmark
Glostrup Municipality, , Denmark
Herlev, , Denmark
Kolding, , Denmark
Odense, , Denmark
Angers, , France
Bordeaux, , France
Clermont-Ferrand, , France
Lille, , France
Nantes, , France
Paris, , France
Reims, , France
Rouen, , France
Saint-Priest-en-Jarez, , France
Toulouse, , France
Bad Ems, , Germany
Emmendingen, , Germany
Frankfurt, , Germany
Freiburg im Breisgau, , Germany
Hagenow, , Germany
Hamburg, , Germany
Koblenz, , Germany
Rheinfelden, , Germany
Trier, , Germany
Uetersen, , Germany
Athens, , Greece
Larissa, , Greece
Pátrai, , Greece
Thessaloniki, , Greece
Budapest, , Hungary
Nyíregyháza, , Hungary
Szolnok, , Hungary
Tatabánya, , Hungary
Montecchio Emilia, , Italy
Novara, , Italy
Orbassano, , Italy
Rome, , Italy
Sassari, , Italy
Sesto San Giovanni, , Italy
Varese, , Italy
Verona, , Italy
Apeldoorn, , Netherlands
Ede, , Netherlands
Eindhoven, , Netherlands
Groningen, , Netherlands
Nijmegen, , Netherlands
Roermond, , Netherlands
Tilburg, , Netherlands
Zeist, , Netherlands
Bodø, , Norway
Haugesund, , Norway
Rud, , Norway
Tønsberg, , Norway
Moscow, , Russia
Saint Petersburg, , Russia
Bratislava, , Slovakia
Košice, , Slovakia
Martin, , Slovakia
Prešov, , Slovakia
Skalica, , Slovakia
Alicante, , Spain
Bilbao, , Spain
Burgos, , Spain
Llobregat, , Spain
Madrid, , Spain
Santiago de Compostela, , Spain
Seville, , Spain
Valencia, , Spain
Valladolid, , Spain
Gothenburg, , Sweden
Malmo, , Sweden
Nyköping, , Sweden
Stockholm, , Sweden
Kiev, , Ukraine
Birmingham, , United Kingdom
Harrow, , United Kingdom
Leicester, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Plymouth, , United Kingdom
Sheffield, , United Kingdom
Stevenage, , United Kingdom
Swansea, , United Kingdom
Countries
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References
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Chapple CR, Martinez-Garcia R, Selvaggi L, Toozs-Hobson P, Warnack W, Drogendijk T, Wright DM, Bolodeoku J; STAR study group. A comparison of the efficacy and tolerability of solifenacin succinate and extended release tolterodine at treating overactive bladder syndrome: results of the STAR trial. Eur Urol. 2005 Sep;48(3):464-70. doi: 10.1016/j.eururo.2005.05.015.
Other Identifiers
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905-EC-001
Identifier Type: -
Identifier Source: org_study_id
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