Status:
COMPLETED
Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma Canada, Inc.
Conditions:
Overactive Bladder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the safety and efficacy of solifenacin with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).
Detailed Description
This study is a prospective randomized, double-blind, double-dummy, multicentre, 2-arm (1 Active, Active Control) comparative parallel group study to compare the safety and efficacy of solifenacin wit...
Eligibility Criteria
Inclusion
- Adults 18 years and older.
- 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
- Urinary tract infection, chronic inflammation such as interstitial cystitis and bladder stones
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00431041
Start Date
December 1 2006
End Date
February 1 2008
Last Update
June 8 2010
Active Locations (12)
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1
Calgary, Alberta, Canada, T2V 4R6
2
Edmonton, Alberta, Canada, T5H 3V9
3
Vancouver, British Columbia, Canada, V6T 2B5
4
Victoria, British Columbia, Canada, V8T 5G1