Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder
NCT ID: NCT00454740
Last Updated: 2014-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
441 participants
INTERVENTIONAL
2004-06-30
2005-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
solifenacin succinate
Oral
Interventions
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solifenacin succinate
Oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma US, Inc.
Locations
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Lawrenceville, New Jersey, United States
Neptune City, New Jersey, United States
West Orange, New Jersey, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Albany, New York, United States
Albany, New York, United States
Bay Shore, New York, United States
Brooklyn, New York, United States
Garden City, New York, United States
Lewiston, New York, United States
New York, New York, United States
Williamsville, New York, United States
Cary, North Carolina, United States
Concord, North Carolina, United States
Hickory, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Bethany, Oklahoma, United States
Tulsa, Oklahoma, United States
Springfield, Oregon, United States
Allentown, Pennsylvania, United States
Bethlehem, Pennsylvania, United States
Media, Pennsylvania, United States
Monroeville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Sellersville, Pennsylvania, United States
Aiken, South Carolina, United States
Charleston, South Carolina, United States
Charleston, South Carolina, United States
Myrtle Beach, South Carolina, United States
Jefferson City, Tennessee, United States
Arlington, Texas, United States
Athens, Texas, United States
Carrollton, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Bountiful, Utah, United States
Layton, Utah, United States
Ogden, Utah, United States
Alexandria, Virginia, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Spokane, Washington, United States
Huntington, West Virginia, United States
Madison, Wisconsin, United States
Anchorage, Alaska, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Little Rock, Arkansas, United States
Dinuba, California, United States
Glendora, California, United States
La Mesa, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Mission Hills, California, United States
Modesto, California, United States
San Bernadino, California, United States
Torrance, California, United States
Upland, California, United States
Valley Village, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Denver, Colorado, United States
Farmington, Connecticut, United States
Norwalk, Connecticut, United States
Trumbull, Connecticut, United States
Waterbury, Connecticut, United States
Washington D.C., District of Columbia, United States
Aventura, Florida, United States
Clearwater, Florida, United States
Clearwater, Florida, United States
Daytona Beach, Florida, United States
Gainesville, Florida, United States
Margate, Florida, United States
New Port Richey, Florida, United States
Orange City, Florida, United States
Orlando, Florida, United States
Saint Augustine, Florida, United States
Tallahassee, Florida, United States
Alpharetta, Georgia, United States
Atlanta, Georgia, United States
Blue Ridge, Georgia, United States
Boise, Idaho, United States
Coeur d'Alene, Idaho, United States
Centralia, Illinois, United States
Chicago, Illinois, United States
Kankakee, Illinois, United States
Niles, Illinois, United States
Evansville, Indiana, United States
Indianapolis, Indiana, United States
Jeffersonville, Indiana, United States
Muncie, Indiana, United States
Baltimore, Maryland, United States
Garrison, Maryland, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Edison, New Jersey, United States
Countries
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References
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Chancellor MB, Zinner N, Whitmore K, Kobashi K, Snyder JA, Siami P, Karram M, Laramee C, Capo' JP Jr, Seifeldin R, Forero-Schwanhaeuser S, Nandy I. Efficacy of solifenacin in patients previously treated with tolterodine extended release 4 mg: results of a 12-week, multicenter, open-label, flexible-dose study. Clin Ther. 2008 Oct;30(10):1766-81. doi: 10.1016/j.clinthera.2008.10.011.
Zinner N, Noe L, Rasouliyan L, Marshall T, Seifeldin R. Impact of solifenacin on resource utilization, work productivity and health utility in overactive bladder patients switching from tolterodine ER. Curr Med Res Opin. 2008 Jun;24(6):1583-91. doi: 10.1185/03007990802081766. Epub 2008 Apr 17.
Swift SE, Siami P, Forero-Schwanhaeuser S. Diary and patient-reported outcomes in patients with severe overactive bladder switching from tolterodine extended release 4 mg/day to solifenacin treatment: An open-label, flexible-dosing, multicentre study. Clin Drug Investig. 2009;29(5):305-16. doi: 10.2165/00044011-200929050-00003.
Zinner N, Noe L, Rasouliyan L, Marshall T, Runken MC, Seifeldin R. Impact of solifenacin on quality of life, medical care use, work productivity, and health utility in the elderly: an exploratory subgroup analysis. Am J Geriatr Pharmacother. 2009 Dec;7(6):373-82. doi: 10.1016/j.amjopharm.2009.11.004.
Capo' JP, Lucente V, Forero-Schwanhaeuser S, He W. Efficacy and tolerability of solifenacin in patients aged >/= 65 years with overactive bladder: post-hoc analysis of 2 open-label studies. Postgrad Med. 2011 Jan;123(1):94-104. doi: 10.3810/pgm.2011.01.2250.
Other Identifiers
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905-UC-006
Identifier Type: -
Identifier Source: org_study_id
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