Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple Sclerosis
NCT ID: NCT00629642
Last Updated: 2024-11-14
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
PHASE4
249 participants
INTERVENTIONAL
2008-03-14
2011-01-28
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
QUADRUPLE
Study Groups
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I.Solifenacin succinate 10mg (2x5mg 1/day)
Oral
Solifenacin Succinate
Oral, 10mg
II.Solifenacin succinate 5mg (5mg 1/day)
Oral
Solifenacin Succinate
Oral, 5mg
III.Oxybutynin hydrochloride 15mg (5mg 3/day)
Oral
Oxybutynin Hydrochloride
Oral, 15mg
IV. Placebo
Oral
Placebo
Oral
Interventions
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Solifenacin Succinate
Oral, 10mg
Solifenacin Succinate
Oral, 5mg
Oxybutynin Hydrochloride
Oral, 15mg
Placebo
Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects with neurogenic detrusor overactivity due to:
* Multiple sclerosis(MS)(EDSS≤8) or
* Spinal cord injury(SCI)(partial or complete lesions)
* MS or SCI symptoms should be stable for \>= 6 months
* Neurogenic detrusor overactivity symptoms should be stable for \>= 6 months
* Subject is willing and able to perform clean, intermittent, catheterization, if required
* Subject is willing and able to take study medication in compliance with the protocol
Exclusion Criteria
* Subjects with Sjögren's Syndrome or any similar symptoms
* Subjects with 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
* Subjects with stress incontinence or mixed incontinence where stress is the predominant factor as determined by the investigator
* Subjects with evidence of pressure sores \>= grade 2
* Subjects with a history of bladder sphincterotomy
* Subjects with known history of vesico-ureteral reflux without upper urinary tract infection
* Any clinically significant condition, which in the opinion of the investigator makes the subject unsuitable for the study or includes a history of acute urinary retention, severe gastrointestinal obstruction (including paralytic ileus or intestinal atony), severe gastrointestinal conditions (including toxic megacolon or ulcerative colitis), myasthenia gravis, narrow angle glaucoma or shallow anterior chamber
* Subjects undergoing hemodialysis
* Subjects with severe hepatic impairment
* Concurrent use of drugs intended to treat symptoms of overactive bladder
* Use of antidepressants or muscle relaxants which have not been administered at a constant dose for \>= 3 months
* Use of non-drug treatment intended to treat overactive bladder symptoms including electrostimulation therapy, botulinum toxin and vanilloids therapy in the six months prior to the commencement of the study
* Use of permanent, indwelling catheters
* Known or suspected hypersensitivity to solifenacin succinate, oxybutynin hydrochloride, other anti cholinergics or lactose
* Concomitant use of a strong CYP3A4 inhibitor, e.g. ketoconazole
* Pregnant women, women who intend to become pregnant during the study, women of childbearing potential who are sexually active and practicing an unreliable method of birth control or women who will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type, hormonal implants and injectable contraceptives
* Participation in any clinical study within 30 days of randomization, or the limit set by national law, whichever is longer
* Employees of the Astellas Group, third parties associated with the study, or the study site
* Subjects with maximum bladder capacity \>= 400ml at visit 2
18 Years
65 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Department of (Neuro) Urology
Role: PRINCIPAL_INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Locations
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Brisbane, , Australia
Melbourne, , Australia
Perth, , Australia
Randwick, , Australia
Antwerp, , Belgium
Esneux, , Belgium
Fraiture-en-Condroz, , Belgium
Ghent, , Belgium
Leuven, , Belgium
Melsbroek, , Belgium
Brno, , Czechia
České Budějovice, , Czechia
Prague, , Czechia
Caen, , France
Garches, , France
Paris, , France
Ploemeur, , France
Berlin, , Germany
Hagenow, , Germany
Heidelberg, , Germany
Kiel, , Germany
Nyíregyháza, , Hungary
Sopron, , Hungary
Szeged, , Hungary
Florence, , Italy
Milan, , Italy
Rome, , Italy
Torino, , Italy
Apeldoorn, , Netherlands
Eindhoven, , Netherlands
Nijmegen, , Netherlands
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Sant Joan d'Alacant, Alicante, Spain
Badalona, Barcelona, Spain
Getafe, Madrid, Spain
A Coruña, , Spain
Cardiff, , United Kingdom
Newcastle upon Tyne, , 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 the Astellas Clinical Study Results website.
Other Identifiers
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2006-005523-42
Identifier Type: OTHER
Identifier Source: secondary_id
905-EC-005
Identifier Type: -
Identifier Source: org_study_id
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