ALF-STONE: Alfuzosin in Uretheric Stones
Phase 3
Terminated
- Conditions
- Prostatic Hyperplasia
- Registration Number
- NCT00454402
- Lead Sponsor
- Sanofi
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 220
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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.
Trial Locations
- Locations (1)
Sanofi-Aventis
🇵🇹Lisbon, Portugal