Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder

Condition(s) targeted: Urinary Bladder, Overactive

Intervention: solifenacin succinate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Astellas Pharma US, Inc.

To evaluate the efficacy of 5 and10mg solifenacin succinate in patients with urgency who have OAB syndrome (urgency, with or without urge incontinence, usually with frequency and nocturia) and wish to switch from tolterodine tartrate extended release to solifenacin succinate due to lack of sufficient improvement in urgency episodes

Official title: An Open-Label Multicenter Study to Assess the Efficacy and Safety of Daily Oral Administration of 5 and 10mg VESIcare® (Solifenacin Succinate) in Patients Who Wish to Switch From Detrol LA® (Tolterodine Tartrate Extended Release) for the Treatment of Overactive Bladder Symptoms Versus: VESIcare® Efficacy and Research Study US

Study design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Evaluate the efficacy of 5 and 10mg solifenacin succinate in patients with urgency who have OAB syndrome.

Secondary outcome:

To assess the improvement in urge incontinence, frequency,nocturia, and urgency

Number of patients satisfied with treatment

Assessment of efficacy

Evaluation of the safety and tolerability

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with OAB who have been treated with tolterodine tartrate extended release for

at least 4 weeks immediately preceding entry into the study, and wish to switch to solifenacin succinate due to lack of sufficient improvement in urgency episodes.

- Previous non-drug treatment of OAB is allowed if it has been established at least 4

weeks prior to Screening and is continued throughout the study.

- At least 3 urinary urgency episodes/24 hours while receiving tolterodine tartrate

extended release documented in a 3-day patient diary in the pre-washout assessments on tolterodine tartrate extended release with or without urge incontinence described as OAB syndrome.

- Prior to treatment with tolterodine tartrate extended release, patients must have had

OAB syndrome for 3 or more months.

Exclusion Criteria:

- Previous treatment with darifenacin

- Treatment with tolterodine tartrate extended release for less than 4 weeks prior to

enrollment in the study.

- Significant stress incontinence or mixed stress/urge incontinence where stress is the

predominant factor as determined by the investigator.

- Evidence of a urinary tract infection; chronic inflammation such as interstitial

cystitis and bladder stones.

- Clinically significant outflow obstruction as determined by the Investigator

- Uncontrolled narrow angle glaucoma, urinary or gastric retention.

- All patients with severe renal or hepatic impairment will be excluded

- Patients with chronic severe constipation or history of diagnosed gastrointestinal

obstructive disease.

Anchorage, Alaska 99508, United States

Scottsdale, Arizona 85258, United States

Phoenix, Arizona 85032, United States

Little Rock, Arkansas 72211, United States

La Mesa, California 91942, United States

Los Angeles, California 90057, United States

Dinuba, California 93618, United States

San Bernadino, California 92404, United States

Glendora, California 91741, United States

Los Angeles, California 90048, United States

Mission Hills, California 91345, United States

Modesto, California 95350, United States

Los Angeles, California 90017, United States

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upland, California 91786, United States

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Denver, Colorado 80220, United States

Waterbury, Connecticut 06708, United States

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Washington, District of Columbia 20017, United States

Daytona Beach, Florida 32114, United States

St Augustine, Florida 32086, United States

Orange City, Florida 32763, United States

Gainesville, Florida 32607, United States

Clearwater, Florida 33761, United States

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Clearwater, Florida 33765, United States

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Aventura, Florida 33180, United States

Margate, Florida 33063, United States

Atlanta, Georgia 30342, United States

Blue Ridge, Georgia 30513, United States

Alpharetta, Georgia 30005, United States

Coeur d'Alene, Idaho 83814, United States

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Niles, Illinois 60714, United States

Kankakee, Illinois 60901, United States

Chicago, Illinois 60616, United States

Centralia, Illinois 62801, United States

Jeffersonville, Indiana 47130, United States

Indianapolis, Indiana 46202, United States

Evansville, Indiana 47714, United States

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St Louis, Missouri 63141, United States

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Lewiston, New York 14092, United States

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Albany, New York 12205, United States

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Brooklyn, New York 11235, United States

Hickory, North Carolina 28601, United States

Concord, North Carolina 28025, United States

Cary, North Carolina 27511, United States

Cincinnati, Ohio 45220, United States

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Cleveland, Ohio 44195, United States

Tulsa, Oklahoma 74136, United States

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Springfield, Oregon 97411, United States

Sellersville, Pennsylvania 18760, United States

Philadelphia, Pennsylvania 19104, United States

Pittsburgh, Pennsylvania 15213, United States

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Ogden, Utah 84403, United States

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Richmond, Virginia 23294, United States

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Spokane, Washington 99202, United States

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Madison, Wisconsin 53717, United States

Starting date: June 2004
Ending date: August 2005
Last updated: April 1, 2008