Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Tolterodine is approved for use in the treatment of overactive bladder (OAB). The study is designed to a investigate whether pregabalin may have efficacy in OAB and whether the efficacy is altered when it is combined with tolterodine.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Tolterodine SR 2 mg once daily combined with pregabalin 75 mg twice daily |
|
| B | Active Comparator | Tolterodine SR 4 mg once daily |
|
| C | Placebo Comparator | Placebo |
|
| D | Experimental | Tolterodine SR 4 mg once daily combined with pregabalin 150 mg twice daily |
|
| E | Experimental | Pregabalin 150 mg twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tolterodine & Pregabalin | Drug | Tolterodine SR Oral, 2mg, once daily for 4 weeks Pregabalin, Oral, 75 mg, twice daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean voided volume per micturition (from baseline). | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage and absolute change in incontinence episode frequency after 4 weeks of treatment (for subjects with incontinence at baseline). | 4 Weeks | |
| Percentage and absolute change in urgency episode frequency | 4 Weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Hradec Králové | 500 05 | Czechia | |||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Tolterodine | Drug | Tolterodine SR, Oral, 4 mg, once daily for 4 weeks |
|
| Placebo | Drug | Placebo, Oral, twice daily for 4 weeks |
|
| Tolterodine & Pregabalin | Drug | Tolterodine SR Oral, 4mg, once daily for 4 weeks Pregabalin, Oral, 150 mg, twice daily for 4 weeks |
|
| Pregabalin | Drug | Pregabalin, Oral, 150 mg twice daily for 4 weeks |
|
| Mean severity of urgency episodes | 4 Weeks |
| Percentage and absolute change in micturition frequency | 4 Weeks |
| Percentage and absolute change in normalized micturition frequency (NMF) | 4 Weeks |
| Patient perception of their urinary urgency (using the OAB-q symptom severity scale) | 4 Weeks |
| Patient perception of Health Related Quality of Life (using the OAB-q SF HRQL scale) | 4 Weeks |
| Patient Perception of Bladder Condition (PPBC) scale | 4 Weeks |
| Prague |
| 110 00 |
| Czechia |
| Pfizer Investigational Site | Prague | 130 00 | Czechia |
| Pfizer Investigational Site | Praha 4 - Krc | 140 59 | Czechia |
| Pfizer Investigational Site | Ústí nad Labem | 401 13 | Czechia |
| Pfizer Investigational Site | Kaunas | LT-47144 | Lithuania |
| Pfizer Investigational Site | Kaunas | LT-50009 | Lithuania |
| Pfizer Investigational Site | Vilnius | LT-01118 | Lithuania |
| Pfizer Investigational Site | Vilnius | LT-08661 | Lithuania |
| Pfizer Investigational Site | Haugesund | 5507 | Norway |
| Pfizer Investigational Site | Moelv | N-2390 | Norway |
| Pfizer Investigational Site | Trondheim | 7006 | Norway |
| Pfizer Investigational Site | Martin | Slovakia | Slovakia |
| Pfizer Investigational Site | Bratislava | 901 01 | Slovakia |
| Pfizer Investigational Site | Košice | 040 11 | Slovakia |
| Pfizer Investigational Site | Skalica | 909 82 | Slovakia |
| Pfizer Investigational Site | Luleå | 97180 | Sweden |
| Pfizer Investigational Site | Norrköping | 601 82 | Sweden |
| Pfizer Investigational Site | Stockholm | 141 86 | Sweden |
| Pfizer Investigational Site | Dundee | Tayside | DD1 9SY | United Kingdom |
| Pfizer Investigational Site | Bristol | BS10 5NB | United Kingdom |
| Pfizer Investigational Site | Dundee | DD1 9SY | United Kingdom |
| Pfizer Investigational Site | Plymouth | PL6 8DH | United Kingdom |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068737 | Tolterodine Tartrate |
| D000069583 | Pregabalin |
| 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 |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided