ALF-STONE: Alfuzosin in Uretheric Stones

Sanofi

Status and phase: Terminated; Phase 3

Conditions: Prostatic Hyperplasia

Treatments: Drug: Alfuzosin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00454402

L_9795

EudraCT # : 2005-005481-36

Details and patient eligibility

About

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).

Enrollment: 220 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind