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This is a pilot study to generate hypotheses about the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| UK-369,003 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UK-369,003 | Drug | 100 mg MR tablet once daily for 2 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| There is no specific primary endpoint for this study as it is not powered for that. It is mainly to generate hypotheses on the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms. | Duration of study |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum flow rate (Qmax) | Duration of study | |
| Cystometric capacity | Duration of study | |
| Post void residual volume (PVR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Brno | 612 00 | Czechia | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C553931 | 1-(6-ethoxy-5-(3-ethyl-6,7-dihydro-2-(2-methoxyethyl)-7-oxo-2H-pyrazolo(4,3-d)pyrimidin-5-yl)-3-pyridyl sulphonyl)-4-ethylpiperazine |
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| UK-369,003 |
| Drug |
UK-369,003-100 mg MR formulation for 2 weeks |
|
| Duration of study |
| Average flow rate (Qave) | Duration of study |
| Volume at first unstable contraction | Duration of study |
| Average detrusor pressure during micturition | Duration of study |
| Detrusor pressure at maximum flow rate (PdetQmax) | Duration of study |
| Bladder outlet obstruction index (BOOI) | Duration of study |
| Bladder contractility index (BCI) | Duration of study |
| Bladder voiding efficiency (BE) | Duration of study |
| Frequency of unstable contractions | Duration of study |
| International Prostate Symptom Score (IPSS) | Duration of study |
| Mean amplitude of unstable contractions | Duration of study |
| Patient Reported Treatment Impact (PRTI) | Duration of study |
| Hradec Králové |
| 500 02 |
| Czechia |
| Pfizer Investigational Site | Olomouc | 775 20 | Czechia |
| Pfizer Investigational Site | Ústí nad Labem | 401 13 | Czechia |
| Pfizer Investigational Site | Amsterdam | 1081 HV | Netherlands |
| Pfizer Investigational Site | Nijmegen | 6525 GA | Netherlands |
| Pfizer Investigational Site | Bratislava | Slovakia | 833 05 | Slovakia |
| Pfizer Investigational Site | Martin | Slovakia | 036 59 | Slovakia |
| Pfizer Investigational Site | Trenčín | Slovakia | 911 01 | Slovakia |
| Pfizer Investigational Site | Košice | 040 11 | Slovakia |
| Pfizer Investigational Site | Košice | 041 90 | Slovakia |
| D052801 |
| Male Urogenital Diseases |