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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT # : 2005-005481-36 |
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Discontinued due to incomplete recruitment
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The aim of the study is to assess the effect of Alfuzosin compared with placebo, for 7 days, on the outcome of patients with uretheric stones submitted to Extracorporeal Shock Wave Lithotripsy (ESWL), namely in the percentage of patients without imagiologic evidence of any stone after 72h to 96 hours.
This study will also specifically focus on the evaluation of time of stone clearance and of pain reduction (Numeric Rating Scale).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alfuzosin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: General clinical safety by collection of spontaneously reported adverse events | at each visit | |
| Efficacy: Percentage of patients without imagiologic evidence of any stone | 72h to 96 hours after ESWL |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients without imagiologic evidence of any stone | 24 hours after ESWL | |
| Percentage of patients with clinical evidence of stones clearance | 72h to 96 hours after ESWL | |
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Inclusion criteria:
Exclusion criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Santos, MD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis | Lisbon | Portugal |
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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 |
|---|---|
| C047638 | alfuzosin |
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| Time for stone clearance (clinical evaluation) |
| Numeric Rating Scale scores | at 24h, (48h, if applicable), 72-96h and 7 days |
| Need for rescue analgesic medication. |
| D052801 |
| Male Urogenital Diseases |