Study of VESIcare® In Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life
NCT ID: NCT00573508
Last Updated: 2010-10-05
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
768 participants
INTERVENTIONAL
2007-08-31
2008-07-31
Brief Summary
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Detailed Description
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The study duration consists of a screening period which includes a minimum of a 14 day treatment free wash-out period. Subjects meeting the baseline criteria will have a 12 week treatment period. Maximum total study duration is 15 weeks: 2 3 week screening / washout period; 12 week double-blind treatment.
Primary efficacy will be based on OAB-q symptom bother score.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Matching placebo tablet taken once daily
Placebo
Oral Administration
Solifenacin Succinate
5mg or 10mg tablet taken once daily
Solifenacin Succinate
Oral Administration
Interventions
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Placebo
Oral Administration
Solifenacin Succinate
Oral Administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of OAB symptoms for ≥ 3 months
* An average of ≥ 8 micturitions per 24 hours and ≥ 1 urgency episode (with or without incontinence) per 24 hours as documented in a 3-day micturition diary
* Subjects are bothered by symptoms as reflected by PPBC ≥3
Exclusion Criteria
* Recurrent urinary tract infection (UTI) of \> 3 episodes within the last 3 months or evidence of a urinary tract infection at Baseline Visit (Visit 2)
* Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator
* History of renal or hepatic impairment(2 x Upper Limit of Normal(ULN) values in parameters and considered clinically significant by the investigator
* History of diagnosed gastrointestinal obstruction disease
* Subject has a known diagnosis or history of carcinoma (including prostate cancer) except non metastatic basal or squamous cell carcinoma of the skin that has been successfully treated or previous pelvis radiation within the past five years
* Known or suspected hypersensitivity to solifenacin succinate, any components, or other anticholinergics
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Astellas Pharma US, Inc
Principal Investigators
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Central Contact
Role: STUDY_DIRECTOR
Astellas Pharma US, Inc.
Locations
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Montgomery, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Buena Park, California, United States
Carmichael, California, United States
Fresno, California, United States
Sacramento, California, United States
San Bernardino, California, United States
San Diego, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Denver, Colorado, United States
Englewood, Colorado, United States
Waterbury, Connecticut, United States
Clearwater, Florida, United States
Plantation, Florida, United States
Tallahassee, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Wellington, Florida, United States
Roswell, Georgia, United States
Idaho Falls, Idaho, United States
Melrose Park, Illinois, United States
Jeffersonville, Indiana, United States
Shreveport, Louisiana, United States
Watertown, Massachusetts, United States
Billings, Montana, United States
Omaha, Nebraska, United States
Englewood, New Jersey, United States
Lawrenceville, New Jersey, United States
Endwell, New York, United States
Garden City, New York, United States
Kingston, New York, United States
New York, New York, United States
New York, New York, United States
Orchard Park, New York, United States
Poughkeepsie, New York, United States
Concord, North Carolina, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Cincinnati, Ohio, United States
Lyndhurst, Ohio, United States
Edmond, Oklahoma, United States
Central Point, Oregon, United States
Philadelphia, Pennsylvania, United States
Uniontown, Pennsylvania, United States
West Reading, Pennsylvania, United States
Greer, South Carolina, United States
Simpsonville, South Carolina, United States
Arlington, Texas, United States
Austin, Texas, United States
Bedford, Texas, United States
Corpus Christi, Texas, United States
Houston, Texas, United States
Mount Lake, Washington, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Madison, Wisconsin, United States
Countries
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References
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Vardy MD, Mitcheson HD, Samuels TA, Wegenke JD, Forero-Schwanhaeuser S, Marshall TS, He W. Effects of solifenacin on overactive bladder symptoms, symptom bother and other patient-reported outcomes: results from VIBRANT - a double-blind, placebo-controlled trial. Int J Clin Pract. 2009 Dec;63(12):1702-14. doi: 10.1111/j.1742-1241.2009.02209.x.
Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
Crosby RD, Mathias SD, Marshall TS. Relationships between symptoms, symptom bother, and health-related quality of life in patients with overactive bladder taking solifenacin or placebo in the VIBRANT study. Int J Clin Pract. 2011 Feb;65(2):211-8. doi: 10.1111/j.1742-1241.2010.02532.x.
Related Links
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Link to Prescribing Information
Other Identifiers
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905-UC-010
Identifier Type: -
Identifier Source: org_study_id