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

NCT00454740 | Completed Phase 3

• 1 other identifier: 905-UC-006
• Study Type: interventional
• Target: 441
• Locations: 1 country
• Sites: 104

Brief Summary

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

Conditions

Urinary Bladder, Overactive

Keywords

Urinary Bladder, Overactive; Urgency; VESIcare®; Solifenacin succinate

Outcome Measures

Primary Outcomes (1)

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

  Weeks 1, 4, 8 and 12

Secondary Outcomes (4)

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

  Weeks 1, 4, 8 and 12

• Number of patients satisfied with treatment

  Weeks 1, 4, 8 and 12

• Assessment of efficacy

  End of study

• Evaluation of the safety and tolerability

  Baseline to end of study

Study Arms (1)

1

EXPERIMENTAL

Drug: solifenacin succinate

Interventions

solifenacin succinate DRUG

Oral

Also known as: VESIcare(R), YM905

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (104)

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Anchorage, Alaska, 99508, United States

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Phoenix, Arizona, 85032, United States

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Scottsdale, Arizona, 85258, United States

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Little Rock, Arkansas, 72211, United States

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Dinuba, California, 93618, United States

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Glendora, California, 91741, United States

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La Mesa, California, 91942, United States

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Los Angeles, California, 90017, United States

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Los Angeles, California, 90048, United States

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Los Angeles, California, 90057, United States

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Mission Hills, California, 91345, United States

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Modesto, California, 95350, United States

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San Bernadino, California, 92404, United States

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Torrance, California, 90505, United States

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Upland, California, 91786, United States

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Valley Village, California, 91607, United States

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Aurora, Colorado, 80012, United States

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Denver, Colorado, 80205, United States

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Denver, Colorado, 80220, United States

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Farmington, Connecticut, 06302, United States

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Norwalk, Connecticut, 06850, United States

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Trumbull, Connecticut, 06611, United States

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Waterbury, Connecticut, 06708, United States

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Washington D.C., District of Columbia, 20017, United States

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Aventura, Florida, 33180, United States

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Clearwater, Florida, 33761, United States

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Clearwater, Florida, 33765, United States

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Daytona Beach, Florida, 32114, United States

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Gainesville, Florida, 32607, United States

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Margate, Florida, 33063, United States

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New Port Richey, Florida, 34652, United States

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Orange City, Florida, 32763, United States

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Orlando, Florida, 32803, United States

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Saint Augustine, Florida, 32086, United States

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Tallahassee, Florida, 32308, United States

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Alpharetta, Georgia, 30005, United States

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Atlanta, Georgia, 30342, United States

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Blue Ridge, Georgia, 30513, United States

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Boise, Idaho, 83702, United States

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Coeur d'Alene, Idaho, 83814, United States

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Centralia, Illinois, 62801, United States

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Chicago, Illinois, 60616, United States

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Kankakee, Illinois, 60901, United States

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Niles, Illinois, 60714, United States

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Evansville, Indiana, 47714, United States

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Indianapolis, Indiana, 46202, United States

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Jeffersonville, Indiana, 47130, United States

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Muncie, Indiana, 47303, United States

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Baltimore, Maryland, 21204, United States

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Garrison, Maryland, 21117, United States

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St Louis, Missouri, 63117, United States

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St Louis, Missouri, 63141, United States

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Las Vegas, Nevada, 89109, United States

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Edison, New Jersey, 08837, United States

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Lawrenceville, New Jersey, 08648, United States

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Neptune City, New Jersey, 07753, United States

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West Orange, New Jersey, 07052, United States

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Albuquerque, New Mexico, 87108, United States

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Albany, New York, 12205, United States

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Albany, New York, 12206, United States

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Albany, New York, 12208, United States

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Bay Shore, New York, 11706, United States

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Brooklyn, New York, 11235, United States

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Garden City, New York, 11530, United States

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Lewiston, New York, 14092, United States

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New York, New York, 10021, United States

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Williamsville, New York, 14221, United States

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Cary, North Carolina, 27511, United States

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Concord, North Carolina, 28025, United States

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Hickory, North Carolina, 28601, United States

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Cincinnati, Ohio, 45212, United States

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Cincinnati, Ohio, 45220, United States

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Cleveland, Ohio, 44195, United States

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Bethany, Oklahoma, 73008, United States

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Tulsa, Oklahoma, 74136, United States

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Springfield, Oregon, 97411, United States

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Allentown, Pennsylvania, 18103, United States

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Bethlehem, Pennsylvania, 18015, United States

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Media, Pennsylvania, 19063, United States

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Monroeville, Pennsylvania, 15146, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19115, United States

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Philadelphia, Pennsylvania, 19146, United States

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Pittsburgh, Pennsylvania, 15213, United States

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Sellersville, Pennsylvania, 18760, United States

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Aiken, South Carolina, 29801, United States

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Charleston, South Carolina, 19406, United States

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Charleston, South Carolina, 29425, United States

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Myrtle Beach, South Carolina, 29572, United States

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Jefferson City, Tennessee, 37760, United States

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Arlington, Texas, 76017, United States

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Athens, Texas, 75751, United States

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Carrollton, Texas, 75010, United States

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Houston, Texas, 77024, United States

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San Antonio, Texas, 78238, United States

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Bountiful, Utah, 84010, United States

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Layton, Utah, 84041, United States

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Ogden, Utah, 84403, United States

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Alexandria, Virginia, 22304, United States

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Richmond, Virginia, 23294, United States

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Seattle, Washington, 98111, United States

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Spokane, Washington, 99202, United States

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Huntington, West Virginia, 25701, United States

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Madison, Wisconsin, 53717, United States

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Related Publications (5)

• 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.

  PMID: 19014833 BACKGROUND

• 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.

  PMID: 18423103 BACKGROUND

• 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.

  PMID: 19366272 BACKGROUND

• 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.

  PMID: 20129258 BACKGROUND

• 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.

  PMID: 21293089 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Use Central Contact

  Astellas Pharma US, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2007
• First Posted: April 2, 2007
• Study Start: June 1, 2004
• Primary Completion: August 1, 2005
• Study Completion: August 1, 2005
• Last Updated: September 18, 2014

Record last verified: 2014-09

Locations

US (104)