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| Name | Class |
|---|---|
| Procter and Gamble | INDUSTRY |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Darifenacin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darifenacin | Drug | Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the patient's perception of outcome at Week 13 using the Patient Perception Bladder Condition questionnaire (PPBC). |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's perception of outcome using the PPBC questionnaire at Week 7. | ||
| Patient's satisfaction by using the Patient Satisfaction Treatment Benefits questionnaire (PSTB, Part I) at Week 13. | ||
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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
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
Other protocol-defined inclusion / exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceutical Corporation | NPC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Birmingham | Alabama | 35242 | United States | ||
| Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20860020 | Derived | Zinner N, Kobashi K, Koochaki P, Fix D, Egermark M. Patient satisfaction with the benefits of overactive bladder treatment: exploration of influencing factors and development of a satisfaction assessment instrument. Neurourol Urodyn. 2011 Jan;30(1):62-8. doi: 10.1002/nau.20890. Epub 2010 Sep 21. | |
| 18811599 | Derived |
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| Assessment of efficacy of darifenacin with respect to change from baseline in: |
| Number of micturitions per day at Weeks 7 and 13 |
| Number of urgency episodes per day at Weeks 7 and 13 |
| Number of urge urinary incontinence episodes (UUIE) per week at Weeks 7 and 13 |
| Assessment of safety and tolerability |
| Chandler |
| Arizona |
| 85224 |
| United States |
| Investigative Site | Mesa | Arizona | 85206 | United States |
| Investigative Site | Sierra Vista | Arizona | 85635 | United States |
| Investigative Site | Tempe | Arizona | 85282 | United States |
| Investigative Site | Atherton | California | 94027 | United States |
| Investigative Site | Los Angeles | California | 90048 | United States |
| Investigative Site | Newport Beach | California | 92660 | United States |
| Investigative Site | San Diego | California | 92108 | United States |
| Investigative Site | Temecula | California | 92591 | United States |
| Investigative Site | Torrance | California | 90505 | United States |
| Investigative Site | Upland | California | 91786 | United States |
| Investigative Site | Aurora | Colorado | 80012 | United States |
| Investigative Site | Littleton | Colorado | 80122 | United States |
| Investigative Site | Wheat Ridge | Colorado | 80033 | United States |
| Investigative Site | Hollywood | Florida | 33021 | United States |
| Investigative Site | New Smyrna Beach | Florida | 32168 | United States |
| Investigative Site | Ocala | Florida | 34474 | United States |
| Investigative Site | Orlando | Florida | 32803 | United States |
| Investigative Site | Sarasota | Florida | 34237 | United States |
| Investigative Site | Tampa | Florida | 33607 | United States |
| Investigative Site | West Palm Beach | Florida | 33409 | United States |
| Investigative Site | Weston | Florida | 33331 | United States |
| Investigative Site | Alpharetta | Georgia | 30005 | United States |
| Investigative Site | Atlanta | Georgia | 30342 | United States |
| Investigative Site | Marietta | Georgia | 30060 | United States |
| Investigative Site | Roswell | Georgia | 30076 | United States |
| Investigative Site | Snellville | Georgia | 30078 | United States |
| Investigative Site | Melrose Park | Illinois | 60160 | United States |
| Investigative Site | O'Fallon | Illinois | 62269 | United States |
| Investigative Site | Peoria | Illinois | 61615 | United States |
| Investigative Site | Evansville | Indiana | 47714 | United States |
| Investigative Site | Greenwood | Indiana | 46143 | United States |
| Investigative Site | Topeka | Kansas | 66606 | United States |
| Investigative Site | Milford | Massachusetts | 01757 | United States |
| Investigative Site | Watertown | Massachusetts | 02472 | United States |
| Investigative Site | Flint | Michigan | 48507 | United States |
| Investigative Site | Saint Joseph | Michigan | 49085 | United States |
| Investigative Site | Chesterfield | Missouri | 63017 | United States |
| Investigative Site | Kansas City | Missouri | 64114 | United States |
| Investigative Site | St Louis | Missouri | 63136 | United States |
| Investigative Site | Lincoln | Nebraska | 68510 | United States |
| Investigative Site | Omaha | Nebraska | 68114 | United States |
| Investigative Site | Lawrenceville | New Jersey | 08648 | United States |
| Investigative Site | West Orange | New Jersey | 07052 | United States |
| Investigative Site | Albany | New York | 12206 | United States |
| Investigative Site | Garden City | New York | 11530 | United States |
| Investigative Site | Latham | New York | 12110 | United States |
| Investigative Site | Mineola | New York | 11501 | United States |
| Investigative Site | New Hartford | New York | 13413 | United States |
| Investigative Site | Poughkeepsie | New York | 12601 | United States |
| Investigative Site | Troy | New York | 12180 | United States |
| Investigative Site | Williamsville | New York | 14221 | United States |
| Investigative Site | Burlington | North Carolina | 27215 | United States |
| Investigative Site | Charlotte | North Carolina | 28209 | United States |
| Investigative Site | Concord | North Carolina | 28205 | United States |
| Investigative Site | Hickory | North Carolina | 28601 | United States |
| Investigative Site | High Point | North Carolina | 27262 | United States |
| Investigative Site | Salisbury | North Carolina | 28144 | United States |
| Investigative Site | Winston-Salem | North Carolina | 27103 | United States |
| Investigative Site | Cincinnati | Ohio | 45212 | United States |
| Investigative Site | Bethany | Oklahoma | 73008 | United States |
| Investigative Site | Edmond | Oklahoma | 73034 | United States |
| Investigative Site | Portland | Oregon | 97205 | United States |
| Investigative Site | Springfield | Oregon | 97477 | United States |
| Investigative Site | Pittsburgh | Pennsylvania | 15213 | United States |
| Investigative Site | Amarillo | Texas | 79106 | United States |
| Investigative Site | Corsicana | Texas | 75110 | United States |
| Investigative Site | Dallas | Texas | 75231 | United States |
| Investigative Site | Fort Worth | Texas | 76104 | United States |
| Investigative Site | Houston | Texas | 77005 | United States |
| Investigative Site | Lake Jackson | Texas | 77566 | United States |
| Investigative Site | Bountiful | Utah | 84010 | United States |
| Investigative Site | Salt Lake City | Utah | 84124 | United States |
| Investigative Site | Sandy City | Utah | 84070 | United States |
| Investigative Site | Richmond | Virginia | 23294 | United States |
| Investigative Site | Everett | Washington | 98208 | United States |
| Investigative Site | Lakewood | Washington | 98499 | United States |
| Investigative Site | Mountlake Terrace | Washington | 98233 | United States |
| Investigative Site | Seattle | Washington | 98101 | United States |
| Investigative Site | Vancouver | Washington | 98664 | United States |
| Investigative Site | Milwaukee | Wisconsin | 53226 | United States |
| Zinner N, Kobashi KC, Ebinger U, Viegas A, Egermark M, Quebe-Fehling E, Koochaki P. Darifenacin treatment for overactive bladder in patients who expressed dissatisfaction with prior extended-release antimuscarinic therapy. Int J Clin Pract. 2008 Nov;62(11):1664-74. doi: 10.1111/j.1742-1241.2008.01893.x. Epub 2008 Sep 22. |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C101207 | darifenacin |
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