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| Name | Class |
|---|---|
| Procter and Gamble | INDUSTRY |
This study is designed to investigate the efficacy and safety of treatment of overactive bladder with darifenacin administered alone or in conjunction with behavioral modification therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Darifenacin |
|
| 2 | Other | Darifenacin in combination with Behavioral Modification Programme for Symptoms of Overactive Bladder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darifenacin | Drug | Darifenacin tablets 7,5 mg once daily with the possibility to up-titrate to 15 mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in average number of urinations per patient per day at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in average number of urination episodes per patient per day at Week 2, Week 6 | ||
| Change from baseline in average number of urge urinary incontinence episodes, urgency episodes, incontinence pads, and nocturnal urinations per day measured at Weeks 2, 6, 12 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals Corp. | Novartis Pharmaceutical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Research Center | Birmingham | Alabama | 35209 | United States | ||
| Quality of Life Medical & Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37811598 | Derived | Funada S, Yoshioka T, Luo Y, Sato A, Akamatsu S, Watanabe N. Bladder training for treating overactive bladder in adults. Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD013571. doi: 10.1002/14651858.CD013571.pub2. |
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| Darifenacin | Drug | Darifenacin tablets 7,5 mg or 15 mg once daily |
|
| Behavioral therapy | Behavioral | Behavioral Modification Programme for symptoms of overactive bladder |
|
| Quality of Life (baseline, Week 6, Week 12) |
| Tucson |
| Arizona |
| 85712 |
| United States |
| UCLA - Urology Sciences Research Foundation | Culver City | California | 90232 | United States |
| San Diego Center for Urology Care | La Mesa | California | 91942 | United States |
| Orange County Urology Associates | Laguna Woods | California | 92653 | United States |
| Atlantic Urology Medical Group | Long Beach | California | 90806 | United States |
| California Professional Research | Newport Beach | California | 92660 | United States |
| Private Practice | North Hollywood | California | 91607 | United States |
| Medical Center for Clinical Research | San Diego | California | 92108 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| Western Clinical Research | Torrance | California | 90505 | United States |
| Urology Research Options | Aurora | Colorado | 80012 | United States |
| Western Urologic Associates | Wheat Ridge | Colorado | 80033 | United States |
| Connecticut Clinical Research Center | Waterbury | Connecticut | 06708 | United States |
| South Florida Medical Research | Aventura | Florida | 33180 | United States |
| Advance Research Institute | New Port Richey | Florida | 34652 | United States |
| Florida Healthcare Research | Ocala | Florida | 34474 | United States |
| Winter Park Urology Associates | Orlando | Florida | 32803 | United States |
| Atlanta Medical Research Institute | Alpharetta | Georgia | 30005 | United States |
| Shepard Center | Atlanta | Georgia | 30309 | United States |
| Deerpath Physicians Group | Gurnee | Illinois | 60031 | United States |
| RMD Clinical Research Institute | Melrose Park | Illinois | 60160 | United States |
| Southern Illinois Clinical Research Center | O'Fallon | Illinois | 62269 | United States |
| Springfield Clinic | Springfield | Illinois | 62701 | United States |
| Welborn Clinic | Evansville | Indiana | 47714 | United States |
| Urology of Indiana | Indianapolis | Indiana | 46254 | United States |
| Metropolitan Urology | Jeffersonville | Indiana | 47130 | United States |
| Urologic Surgery Associates | Overland Park | Kansas | 66215 | United States |
| Pratt Internal Medicine Group | Pratt | Kansas | 67124 | United States |
| Cotton-O'Neil Clinic | Topeka | Kansas | 66606 | United States |
| Hearthland Research Associates | Wichita | Kansas | 67207 | United States |
| Adult and Pediatric Urology | Saint Cloud | Minnesota | 56303 | United States |
| Mississippi Urology Clinical Research | Jackson | Mississippi | 39202 | United States |
| PPS Clinical Research | St Louis | Missouri | 63141 | United States |
| Washing Univ School of Medicine - Urologic Research Center | St Louis | Missouri | 63141 | United States |
| Women's Clinic of Lincoln | Lincoln | Nebraska | 68510 | United States |
| Quality Clinical Research | Omaha | Nebraska | 68131 | United States |
| Meridian Clinical Research | Omaha | Nebraska | 68134 | United States |
| Lawrenceville Urology | Lawrenceville | New Jersey | 08648 | United States |
| Center for Urologic Care | Voorhees Township | New Jersey | 08043 | United States |
| Central New York Clinical Research | Manlius | New York | 13104 | United States |
| Hudson Valley Urology | Poughkeepsie | New York | 12601 | United States |
| Jacobi Medical Center | The Bronx | New York | 10461 | United States |
| Northeast Urology Research | Concord | North Carolina | 28025 | United States |
| Multi Specialty Research Associates of NC | Raleigh | North Carolina | 27609 | United States |
| Piedmont Medical Research Associates | Winston-Salem | North Carolina | 27103 | United States |
| Private Practice | Edmond | Oklahoma | 73034 | United States |
| Southern Oregon Health and Wellness | Medford | Oregon | 97504 | United States |
| Portland Clinic | Portland | Oregon | 97205 | United States |
| Williamette Women's Health | Tualatin | Oregon | 97232 | United States |
| Univ. of Pittsburgh Medical Center- Dept of Urology | Pittsburgh | Pennsylvania | 15213 | United States |
| Research Protocol Management Specialists | Pittsburgh | Pennsylvania | 15243 | United States |
| South Carolina Clinical Research Center | Columbia | South Carolina | 29201 | United States |
| Doctors for Women | Nashville | Tennessee | 37203 | United States |
| Medical Arts Clinic | Corsicana | Texas | 75110 | United States |
| Radiant Research | Dallas | Texas | 75231 | United States |
| Urology Clinics of North Texas | Dallas | Texas | 75231 | United States |
| Advances in Health | Houston | Texas | 77030 | United States |
| Kelsey Seybold Research Foundation | Houston | Texas | 77054 | United States |
| R/D Clinical Research | Lake Jackson | Texas | 77566 | United States |
| Progressive Clinical Research | Centerville | Utah | 84014 | United States |
| Intermountain Clinical Research | Salt Lake City | Utah | 84102 | United States |
| Salt Lake Research | Salt Lake City | Utah | 84124 | United States |
| Virginia Urology | Richmond | Virginia | 23235 | United States |
| East Coast Clinical Research | Virginia Beach | Virginia | 23454 | United States |
| Radiant Research | Lakewood | Washington | 98499 | United States |
| Valley Women's Clinic | Renton | Washington | 98055 | United States |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D053201 | Urinary Bladder, Overactive |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| 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 |
| D001745 | Urinary Bladder Diseases |
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| ID | Term |
|---|---|
| C101207 | darifenacin |
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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