A Multicenter VESIcare® Efficacy and Safety Study for the Treatment of Urgency Associated With Overactive Bladder (OAB)

Condition(s) targeted: Urinary Bladder, Overactive

Intervention: VESIcare®, 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.

The purpose is to evaluate the efficacy of 5 and 10mg VESIcare® (solifenacin succinate) in patients with urgency who have overactive bladder syndrome.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess the Efficacy and Safety of Daily Oral Administration of 5mg and 10mg VESIcare® for the Treatment of Urgency Associated With Overactive Bladder

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel 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: Improvement of urgency; improvement of frequency, incontinence and nocturia; number of patients satisfied with treatment; assessment of the efficacy; evaluation of the safety and tolerability

Minimum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- At least 1 urinary urgency episode/24h (on average) documented in a 3-day patient diary in the screening phase with or without urge incontinence, and usually with frequency and nocturia, described as OAB

- Patients may be included if they were never exposed to anticholinergic agents specified for the treatment of OAB. Patients may also be included if they have previously been treated with FDA-approved anticholinergic agents for the treatment of OAB such as oxybutynin chloride and are no longer receiving such treatment for a minimum of 14 days immediately preceding entry into the study. These previously treated patients must present at the investigative site on no anticholinergic agents and with the desire to receive treatment for OAB. Previous non-drug treatment of OAB is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study.

- Patients having urgency with or without urge incontinence accompanied by frequency of ≥8 episodes per 24 hours, and/or nocturia, for a period of ≥3 months prior to screening.

Exclusion Criteria:

- Previous treatment with darifenacin

- Duration of urgency with or without urge incontinence, usually accompanied with frequency and nocturia for <3 months

- 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 (benign prostatic hyperplasia) as determined by the Investigator

Scottsdale, Arizona, United States

Phoenix, Arizona, United States

Salinas, California, United States

Mission Viejo, California, United States

Los Angeles, California, United States

Fresno, California, United States

Mission Hills, California, United States

Escondido, California, United States

Valley Village, California, United States

Atherton, California, United States

Carmichael, California, United States

Aurora, Colorado, United States

Denver, Colorado, United States

Trumbull, Connecticut, United States

Norwalk, Connecticut, United States

Waterbury, Connecticut, United States

New London, Connecticut, United States

Washington, District of Columbia, United States

Boyton Beach, Florida, United States

Pembroke Pines, Florida, United States

Plantation, Florida, United States

Gainesville, Florida, United States

Clearwater, Florida, United States

Tallahassee, Florida, United States

Atlanta, Georgia, United States

Blue Ridge, Georgia, United States

Alpharetta, Georgia, United States

Marietta, Georgia, United States

Boise, Idaho, United States

Centralia, Illinois, United States

Slidell, Louisiana, United States

Bloomfield Hills, Michigan, United States

St Louis, Missouri, United States

Chesterfield, Missouri, United States

Billings, Montana, United States

South Bound Brook, New Jersey, United States

Lawrenceville, New Jersey, United States

Albuquerque, New Mexico, United States

Lewiston, New York, United States

East Syracuse, New York, United States

New York, New York, United States

Albany, New York, United States

Hewlett, New York, United States

Hickory, North Carolina, United States

Concord, North Carolina, United States

Winston-Salem, North Carolina, United States

Bismark, North Dakota, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Eugene, Oregon, United States

Uniontown, Pennsylvania, United States

Monroeville, Pennsylvania, United States

Endwell, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Media, Pennsylvania, United States

Mt Pleasant, South Carolina, United States

Athens, Texas, United States

Ogden, Utah, United States

West Point, Utah, United States

Richmond, Virginia, United States

Spokane, Washington, United States

Vancouver, Washington, United States

Morgantown, West Virginia, United States

Starting date: May 2004
Last updated: March 29, 2007