ALF-STONE: Alfuzosin in Uretheric Stones
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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Alfuzosin in Uretheric Stones|
- Safety: General clinical safety by collection of spontaneously reported adverse events [ Time Frame: at each visit ]
- Efficacy: Percentage of patients without imagiologic evidence of any stone [ Time Frame: 72h to 96 hours after ESWL ]
- Percentage of patients without imagiologic evidence of any stone [ Time Frame: 24 hours after ESWL ]
- Percentage of patients with clinical evidence of stones clearance [ Time Frame: 72h to 96 hours after ESWL ]
- Time for stone clearance (clinical evaluation)
- Numeric Rating Scale scores [ Time Frame: at 24h, (48h, if applicable), 72-96h and 7 days ]
- Need for rescue analgesic medication.
|Study Start Date:||August 2006|
|Study Completion Date:||July 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454402
|Study Director:||Carlos Santos, MD||Sanofi|