Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)
NCT ID: NCT00431041
Last Updated: 2010-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
132 participants
INTERVENTIONAL
2006-12-31
2008-02-29
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
TRIPLE
Study Groups
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Solifenacin
Solifenacin succinate: 5 mg tablets, taken orally, once daily
solifenacin
Oral
Oxybutynin IR
Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
oxybutynin immediate release
Oral
Interventions
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solifenacin
Oral
oxybutynin immediate release
Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Overactive bladder symptoms for greater than or equal to 3 months and as documented in a 3-day patient diary following screening and preceding baseline visit: \> 1 urge episodes/24 hours (average); greater than or equal to 8 micturitions/24 hours (average)
Exclusion Criteria
* Clinically significant outflow obstruction
* Uncontrolled narrow angle glaucoma, urinary, or gastric retention
* Severe renal or hepatic impairment
* Chronic severe constipation or history of diagnosed GI obstructive disease
* Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
* Diagnosis or history of neurogenic bladder
* History of bladder or pelvic cancer
18 Years
ALL
No
Sponsors
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Astellas Pharma Canada, Inc.
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Astellas Pharma US, Inc
Principal Investigators
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Use Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma Canada, Inc.
Locations
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Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Halifax, Nova Scotia, Canada
Guelph, Ontario, Canada
Kitchener, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Countries
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References
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Herschorn S, Stothers L, Carlson K, Egerdie B, Gajewski JB, Pommerville P, Schulz J, Radomski S, Drutz H, Barkin J, Paradiso-Hardy F. Tolerability of 5 mg solifenacin once daily versus 5 mg oxybutynin immediate release 3 times daily: results of the VECTOR trial. J Urol. 2010 May;183(5):1892-8. doi: 10.1016/j.juro.2010.01.012. Epub 2010 Mar 29.
Herschorn S, Pommerville P, Stothers L, Egerdie B, Gajewski J, Carlson K, Radomski S, Drutz H, Schulz J, Barkin J, Hirshberg E, Corcos J. Tolerability of solifenacin and oxybutynin immediate release in older (> 65 years) and younger (</= 65 years) patients with overactive bladder: sub-analysis from a Canadian, randomized, double-blind study. Curr Med Res Opin. 2011 Feb;27(2):375-82. doi: 10.1185/03007995.2010.541433. Epub 2010 Dec 23.
Herschorn S, Vicente C, Piwko C. Canadian cost-effectiveness analysis of solifenacin compared to oxybutynin immediate-release in patients with overactive bladder. J Med Econ. 2010;13(3):508-15. doi: 10.3111/13696998.2010.509244.
Related Links
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Link to prescribing information
Other Identifiers
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VES-001
Identifier Type: -
Identifier Source: org_study_id
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