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| ID | Type | Description | Link |
|---|---|---|---|
| SSR240600C |
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To evaluate the safety and efficacy of SSR240600C versus placebo on clinical and cystometric parameters in patients with OAB and UUI.
Prospective, randomized, parallel group, double-dummy, placebo and active-controlled (Detrol LA - tolterodine) trial wherein patients with OAB or UUI will receive single daily does of either SSR240600C 500 mg, tolterodine 4 mg or placebo for four weeks. Baseline and end of study cystometry will be performed; daily symptom diaries will be completed during the trial and health-related quality of life will be measured before and after study drug treatment. Patients will be followed-up one week after completion of the trial. Study participation will include 5 visits over a period of six weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| SSR240600C | Experimental |
| |
| Tolterodine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSR240600C | Drug | once daily |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in bladder capacity as determined by cystometric parameters from baseline to end of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to end of treatment in:maximum detrusor pressure,volume ar first desire to void,volume at first unstable contraction,micturition frequence,urgency episodes,nocturia episodes,incontinence episodes,HRQOL and overall improvement |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Research LLC | Phoenix | Arizona | 85032 | United States | ||
| Research Tuscon |
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| Drug |
oral |
|
| Tolterodine | Drug | once daily |
|
| Tuscon |
| Arizona |
| 85712 |
| United States |
| Medical Center for Clinical Research | San Diego | California | 92108 | United States |
| Genitourinary Surgical Consultants | Denver | Colorado | 80220 | United States |
| Connecticut Clinical Research Center, Urology Specialists | Waterbury | Connecticut | 06708 | United States |
| Miami Research Associates | Miami | Florida | 33143 | United States |
| Southeastern Research Group | Tallahassee | Florida | 32308 | United States |
| Atlanta Women's Research Institute | Alpharetta | Georgia | 30005 | United States |
| Mount Vernon Clinical Research | Atlanta | Georgia | 30328 | United States |
| Soapstone Center for Education & Clinical Research | Decatur | Georgia | 30034 | United States |
| Urology of Indiana | Greenwood | Indiana | 46143 | United States |
| Metropolitan Urology | Jeffersonville | Indiana | 47130 | United States |
| Rockhill Medical Plaza | Kansas City | Missouri | 64131 | United States |
| Hudson Valley Urology Center | Kingston | New York | 12401 | United States |
| Hudson Valley Urology | Poughkeepsie | New York | 12601 | United States |
| Daniel Laury | Medford | Oregon | 97504 | United States |
| Philadelphia Women's Research | Philadelphia | Pennsylvania | 19114 | United States |
| Clinical Trials Research Services | Pittsburgh | Pennsylvania | 15206 | United States |
| University Urological Research Institute | Providence | Rhode Island | 02904 | United States |
| Advanced Research Associates | Corpus Christi | Texas | 78414 | United States |
| Tacoma Women's Specialists Research | Tacoma | Washington | 98405 | United States |
| Midwest Research SpecialistsSt. Michael's Hospital | Milwaukee | Wisconsin | 53209 | United States |
| 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 |
|---|---|
| D000068737 | Tolterodine Tartrate |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |
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