ALF-STONE: Alfuzosin in Uretheric Stones
Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostatic Hyperplasia
Intervention: Alfuzosin (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Sanofi Official(s) and/or principal investigator(s): Carlos Santos, MD, Study Director, Affiliation: Sanofi
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).
Clinical Details
Official title: Alfuzosin in Uretheric Stones
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Safety: General clinical safety by collection of spontaneously reported adverse eventsEfficacy: Percentage of patients without imagiologic evidence of any stone
Secondary outcome: Percentage of patients without imagiologic evidence of any stonePercentage of patients with clinical evidence of stones clearance Time for stone clearance (clinical evaluation) Numeric Rating Scale scores Need for rescue analgesic medication.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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.
Locations and Contacts
Sanofi-Aventis, Lisbon, Portugal
Additional Information
Starting date: August 2006
Last updated: September 21, 2007
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