Prostatic Hyperplasia
Conditions
Brief summary
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).
Interventions
DRUGAlfuzosin
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with imagiologic evidence of uretheric stones
Exclusion criteria
* Women pregnant or breast feeding * Patients with renal impairment (creatinine \> 2mg/dl) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Time for stone clearance (clinical evaluation) | — |
| Percentage of patients without imagiologic evidence of any stone | 24 hours after ESWL |
| Need for rescue analgesic medication. | — |
| Numeric Rating Scale scores | at 24h, (48h, if applicable), 72-96h and 7 days |
| Percentage of patients with clinical evidence of stones clearance | 72h to 96 hours after ESWL |
Countries
Portugal
Outcome results
None listed