Overactive Bladder (OAB) Clinical Trial
Official title:
A 12-Week, Open-Label, Non-Randomized, Multicenter Study to Evaluate the Patient's Perception of Outcome After Treatment With Darifenacin in Overactive Bladder (OAB) Patients Dissatisfied With Prior Anticholinergic Therapy
Verified date | January 2008 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study will evaluate safety, efficacy and patient's perception of outcome after treatment with darifenacin (7.5 mg once daily (o.d.) with voluntary increase up to 15 mg o.d.) in patients with OAB who are dissatisfied with prior oxybutynin extended release (ER) or tolterodine extended release (ER) therapy.
Status | Completed |
Enrollment | 500 |
Est. completion date | September 2007 |
Est. primary completion date | |
Accepts healthy volunteers | |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - • Symptoms of OAB for at least six months prior to randomization - = 8 micturitions on average/24 hours - = 1 urgency episodes on average/24 hours - with or without UUIE - Patients dissatisfied with prior oxybutynin ER or tolterodine ER treatment. Patients must have been on either treatment for at least 1 week and up to 12 months preceding this study. It is required that either oxybutynin ER or tolterodine ER was the most recent OAB medication taken. - Patients without prior darifenacin treatment Exclusion Criteria: - • A mean daily urinary volume >3000 mL or a mean volume voided/micturition of >300 mL as verified in the micturition diary for two consecutive days prior to Baseline - Males with post-void residual (PVR) urinary volume >200 mL at Baseline - Clinically predominant and bothersome stress urinary incontinence, as determined by the investigator - Urinary retention or clinically significant bladder outlet obstruction as determined by the investigator Other protocol-defined inclusion / exclusion criteria may apply |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Investigative Site | Albany | New York |
United States | Investigative Site | Alpharetta | Georgia |
United States | Investigative Site | Amarillo | Texas |
United States | Investigative Site | Atherton | California |
United States | Investigative Site | Atlanta | Georgia |
United States | Investigative Site | Aurora | Colorado |
United States | Investigative Site | Bethany | Oklahoma |
United States | Investigative Site | Birmingham | Alabama |
United States | Investigative Site | Bountiful | Utah |
United States | Investigative Site | Burlington | North Carolina |
United States | Investigative Site | Chandler | Arizona |
United States | Investigative Site | Charlotte | North Carolina |
United States | Investigative Site | Chesterfield | Missouri |
United States | Investigative Site | Cincinnati | Ohio |
United States | Investigative Site | Concord | North Carolina |
United States | Investigative Site | Corsicana | Texas |
United States | Investigative Site | Dallas | Texas |
United States | Investigative Site | Edmond | Oklahoma |
United States | Investigative Site | Evansville | Indiana |
United States | Investigative Site | Everett | Washington |
United States | Investigative Site | Flint | Michigan |
United States | Investigative Site | Fort Worth | Texas |
United States | Investigative Site | Garden City | New York |
United States | Investigative Site | Greenwood | Indiana |
United States | Investigative Site | Hickory | North Carolina |
United States | Investigative Site | High Point | North Carolina |
United States | Investigative Site | Hollywood | Florida |
United States | Investigative Site | Houston | Texas |
United States | Investigative Site | Kansas City | Missouri |
United States | Investigative Site | Lake Jackson | Texas |
United States | Investigative Site | Lakewood | Washington |
United States | Investigative Site | Latham | New York |
United States | Investigative Site | Lawrenceville | New Jersey |
United States | Investigative Site | Lincoln | Nebraska |
United States | Investigative Site | Littleton | Colorado |
United States | Investigative Site | Los Angeles | California |
United States | Investigative Site | Marietta | Georgia |
United States | Investigative Site | Melrose Park | Illinois |
United States | Investigative Site | Mesa | Arizona |
United States | Investigative Site | Milford | Massachusetts |
United States | Investigative Site | Milwaukee | Wisconsin |
United States | Investigative Site | Mineola | New York |
United States | Investigative Site | Mountlake Terrace | Washington |
United States | Investigative Site | New Hartford | New York |
United States | Investigative Site | New Smyrna Beach | Florida |
United States | Investigative Site | Newport Beach | California |
United States | Investigative Site | O'Fallon | Illinois |
United States | Investigative Site | Ocala | Florida |
United States | Investigative Site | Omaha | Nebraska |
United States | Investigative Site | Orlando | Florida |
United States | Investigative Site | Peoria | Illinois |
United States | Investigative Site | Pittsburgh | Pennsylvania |
United States | Investigative Site | Portland | Oregon |
United States | Investigative Site | Poughkeepsie | New York |
United States | Investigative Site | Richmond | Virginia |
United States | Investigative Site | Roswell | Georgia |
United States | Investigative Site | Saint Joseph | Michigan |
United States | Investigative Site | Salisbury | North Carolina |
United States | Investigative Site | Salt Lake City | Utah |
United States | Investigative Site | San Diego | California |
United States | Investigative Site | Sandy | Utah |
United States | Investigative Site | Sarasota | Florida |
United States | Investigative Site | Seattle | Washington |
United States | Investigative Site | Sierra Vista | Arizona |
United States | Investigative Site | Snellville | Georgia |
United States | Investigative Site | Springfield | Oregon |
United States | Investigative Site | St. Louis | Missouri |
United States | Investigative Site | Tampa | Florida |
United States | Investigative Site | Temecula | California |
United States | Investigative Site | Tempe | Arizona |
United States | Investigative Site | Topeka | Kansas |
United States | Investigative Site | Torrance | California |
United States | Investigative Site | Troy | New York |
United States | Investigative Site | Upland | California |
United States | Investigative Site | Vancouver | Washington |
United States | Investigative Site | Watertown | Massachusetts |
United States | Investigative Site | West Orange | New Jersey |
United States | Investigative Site | West Palm Beach | Florida |
United States | Investigative Site | Weston | Florida |
United States | Investigative Site | Wheat Ridge | Colorado |
United States | Investigative Site | Williamsville | New York |
United States | Investigative Site | Winston Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Novartis | Procter and Gamble |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in the patient's perception of outcome at Week 13 using the Patient Perception Bladder Condition questionnaire (PPBC). | |||
Secondary | Patient's perception of outcome using the PPBC questionnaire at Week 7. | |||
Secondary | Patient's satisfaction by using the Patient Satisfaction Treatment Benefits questionnaire (PSTB, Part I) at Week 13. | |||
Secondary | Assessment of efficacy of darifenacin with respect to change from baseline in: | |||
Secondary | Number of micturitions per day at Weeks 7 and 13 | |||
Secondary | Number of urgency episodes per day at Weeks 7 and 13 | |||
Secondary | Number of urge urinary incontinence episodes (UUIE) per week at Weeks 7 and 13 | |||
Secondary | Assessment of safety and tolerability |
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