Solifenacin Succinate 5mg or 10mg Once Daily in the Treatment of Urgency Symptoms
NCT ID: NCT00801944
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
973 participants
INTERVENTIONAL
2004-04-30
2005-10-31
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
Placebo
Placebo
oral
Interventions
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Solifenacin succinate
oral
Placebo
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for \>= 3 months
* At least 3 episodes of urgency with or without incontinence in last 3 days
* At least three episodes of urgency with or without incontinence (PPIUS grade 3 or 4) during the 3-day micturition diary period
* Patient must experience frequency of micturition on average \>= 8 times per 24-hour period during the 3-day micturition diary period
Exclusion Criteria
* 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 indwelling catheters or practising intermittent self-catheterisation
* 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
* Hypersensitivity to solifenacin or to any of the excipients, uncontrolled narrow angle glaucoma, myasthenia gravis, urinary or gastric retention, severe renal impairment (GFR ≥30 ml/min), moderate or severe hepatic impairment, chronic intestinal disease, megacolon, requirement for dialysis, concomitant use of a strong CYP3A4 inhibitor, e.g. ketoconazole
* Non drug OAB treatment such as bladder-training, biofeedback and pelvic floor exercises are permissible if established at least 4 weeks prior to study start and intended to be continued throughout the study; electrostimulation therapy is not permissible at any time
* Use of drugs intended to treat urinary incontinence
* Diabetic neuropathy
* 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 days prior to randomisation
* Employees of the Yamanouchi Group, third parties associated with the study, or the study site
* Patient who did not complete the micturition diary according to the instructions
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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Antwerp, , Belgium
Bruges, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Hasselt, , Belgium
Kortrijk, , Belgium
Leuven, , Belgium
Liège, , Belgium
Ostrava, , Czechia
Prague, , Czechia
Zlín, , Czechia
Al Mansurah, , Egypt
Lille, , France
Lomme, , France
Mulhouse, , France
Nantes, , France
Nîmes, , France
Paris, , France
Aichach, , Germany
Bad Neuenaher, , Germany
Bamberg, , Germany
Bautzen, , Germany
Berlin, , Germany
Dierdorf, , Germany
Dülmen, , Germany
Düsseldorf, , Germany
Frankfurt, , Germany
Henningsdorf, , Germany
Munich, , Germany
Neustadt, , Germany
Nuremberg, , Germany
Planegg, , Germany
Athens, , Greece
Crete, , Greece
Ioannina, , Greece
Budapest, , Hungary
Nyíregyháza, , Hungary
Pécs, , Hungary
Szeged, , Hungary
Tatabánya, , Hungary
Bari, , Italy
Catanzaro, , Italy
Cinisello Balsamo, , Italy
Magenta, , Italy
Modena, , Italy
Perugia, , Italy
Turin, , Italy
Udine, , Italy
Bydgoszcz, , Poland
Wroclaw, , Poland
Abrantes, , Portugal
Lisbon, , Portugal
Porto, , Portugal
Santarém, , Portugal
Moscow, , Russia
Banska Bysterica, , Slovakia
Martin, , Slovakia
Žilina, , Slovakia
Barcelona, , Spain
Coaña, , Spain
Córdoba, , Spain
Madrid, , Spain
Mérida, , Spain
San Cristóbal de La Laguna, , Spain
Seville, , Spain
Birmingham, , United Kingdom
Cottingham, , United Kingdom
Croydon, , United Kingdom
Edinburgh, , United Kingdom
Huntingdon, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Oldham, , United Kingdom
Stoke-on-Trent, , United Kingdom
Sunderland, , United Kingdom
Torbay, , United Kingdom
Welwyn Garden City, , United Kingdom
Worthing, , United Kingdom
Countries
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References
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Cardozo L, Hessdorfer E, Milani R, Arano P, Dewilde L, Slack M, Drogendijk T, Wright M, Bolodeoku J; SUNRISE Study Group. Solifenacin in the treatment of urgency and other symptoms of overactive bladder: results from a randomized, double-blind, placebo-controlled, rising-dose trial. BJU Int. 2008 Nov;102(9):1120-7. doi: 10.1111/j.1464-410X.2008.07939.x. Epub 2008 Oct 6.
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.
Other Identifiers
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905-EC-002
Identifier Type: -
Identifier Source: org_study_id
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