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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-002361-39 | EudraCT Number |
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The enrollment rate at most centers was unlikely to result in the recruitment of the planned sample size of 40 evaluable subjects.
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The objective of this study is to explore the effects of darifenacin in patients with multiple sclerosis and neurogenic detrusor overactivity. The efficacy, safety and tolerability of darifenacin are already well established in idiopathic detrusor overactivity. Patients with multiple sclerosis and neurogenic detrusor overactivity without detrusor-sphincter-dyssynergia (DSD) will be allocated to darifenacin therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Darifenacin (BAY79-4998) | Drug | Darifenacin 7,5mg tablets once daily for 14 days, darifenacin 7,5mg or 15mg once daily for 14 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in volume at first detrusor contraction as determined by urodynamics | At week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Detrusor pressure at first contraction | At week 4 | |
| Volume at first detectable leakage | At week 4 | |
| Volume at 10/20/30/40 cm H2O |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emmendingen | Baden-Wurttemberg | 79312 | Germany | |||
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| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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| At week 4 |
| Compliance | At week 4 |
| Maximum cystometric bladder capacity | At week 4 |
| 7-day micturition diary: Micturitions | At days 0, 14, 28 |
| 7-day micturition diary: Urgency episodes | At days 0, 14, 28 |
| 7-day micturition diary: Urge urinary incontinence episodes | At days 0, 14, 28 |
| Heidelberg |
| Baden-Wurttemberg |
| 69112 |
| Germany |
| Lahr | Baden-Wurttemberg | 77933 | Germany |
| Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Villingen-Schwenningen | Baden-Wurttemberg | 78054 | Germany |
| Planegg | Bavaria | 82152 | Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
| Oberursel | Hesse | 61440 | Germany |
| Herne | North Rhine-Westphalia | 44627 | Germany |
| Mönchengladbach | North Rhine-Westphalia | 41063 | Germany |
| Mülheim | North Rhine-Westphalia | 45468 | Germany |
| Mainz | Rhineland-Palatinate | 55131 | Germany |
| Halle | Saxony-Anhalt | 06112 | Germany |
| Berlin | State of Berlin | 10115 | Germany |
| Bad Berka | Thuringia | 99437 | Germany |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| 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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