ALF-STONE: Alfuzosin in Uretheric Stones
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|ClinicalTrials.gov Identifier: NCT00454402|
Recruitment Status : Terminated (Discontinued due to incomplete recruitment)
First Posted : March 30, 2007
Last Update Posted : September 24, 2007
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).
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Hyperplasia||Drug: Alfuzosin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||220 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Alfuzosin in Uretheric Stones|
|Study Start Date :||August 2006|
|Actual Study Completion Date :||July 2007|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454402
|Study Director:||Carlos Santos, MD||Sanofi|