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

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2008-02-29

Brief Summary

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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

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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 with oxybutynin immediate-release (IR) for the treatment of overactive bladder (OAB).

Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Solifenacin

Solifenacin succinate: 5 mg tablets, taken orally, once daily

Group Type EXPERIMENTAL

solifenacin

Intervention Type DRUG

Oral

Oxybutynin IR

Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day

Group Type ACTIVE_COMPARATOR

oxybutynin immediate release

Intervention Type DRUG

Oral

Interventions

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solifenacin

Oral

Intervention Type DRUG

oxybutynin immediate release

Oral

Intervention Type DRUG

Other Intervention Names

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VESIcare® YM905

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Canada, Inc.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

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

Site Status

Edmonton, Alberta, Canada

Site Status

Vancouver, British Columbia, Canada

Site Status

Victoria, British Columbia, Canada

Site Status

Halifax, Nova Scotia, Canada

Site Status

Guelph, Ontario, Canada

Site Status

Kitchener, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Countries

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Canada

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.

Reference Type BACKGROUND
PMID: 20303119 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21175373 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20690893 (View on PubMed)

Related Links

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Other Identifiers

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VES-001

Identifier Type: -

Identifier Source: org_study_id

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