Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Overactive Bladder
Intervention: solifenacin (Drug); oxybutynin immediate release (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Astellas Pharma Canada, Inc.
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).
Clinical Details
Official title: VECTOR: A Randomized Double-Blind Study to Assess the Safety and Efficacy of Solifenacin (Vesicare®) in Comparison to Oxybutynin for Overactive Bladder Patients
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Safety of solifenacin as compared to oxybutynin IR in patients with OAB symptoms
Secondary outcome: Efficacy of solifenacin and oxybutynin IR in an exploratory analysis in subjects with OAB symptoms
Detailed description:
This study will be 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 with oxybutynin immediate-release (IR) for the treatment of
overactive bladder (OAB).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Calgary, Alberta T2V 4R6, Canada
Edmonton, Alberta T5H 3V9, Canada
Victoria, British Columbia V8T 5G1, Canada
Vancouver, British Columbia V6T 2B5, Canada
Halifax, Nova Scotia B3H 3A7, Canada
Kitchener, Ontario N2N 2B9, Canada
Toronto, Ontario M5G 1Z5, Canada
Toronto, Ontario M5T 2S8, Canada
Toronto, Ontario M4N 3M5, Canada
Guelph, Ontario N1H 5J1, Canada
Toronto, Ontario M6A 3B5, Canada
Montreal, Quebec H3T 1E2, Canada
Additional Information
Starting date: December 2006
Ending date: February 2008
Last updated: February 20, 2008
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