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NCT00454402 Clinical Trial

ALF-STONE: Alfuzosin in Uretheric Stones

Prostatic Hyperplasia Clinical Trial

Official title:
Alfuzosin in Uretheric Stones

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00454402
Other study ID # L_9795
Secondary ID EudraCT # : 2005
Status Terminated
Phase Phase 3
First received March 29, 2007
Last updated September 21, 2007
Start date August 2006
Est. completion date July 2007

Study information
Verified date September 2007
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Portugal: National Pharmacy and Medicines Institute
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Terminated
Enrollment 220
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Alfuzosin

Locations
Country Name City State
Portugal Sanofi-Aventis Lisbon

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Portugal, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety: General clinical safety by collection of spontaneously reported adverse events at each visit
Primary Efficacy: Percentage of patients without imagiologic evidence of any stone 72h to 96 hours after ESWL
Secondary Percentage of patients without imagiologic evidence of any stone 24 hours after ESWL
Secondary Percentage of patients with clinical evidence of stones clearance 72h to 96 hours after ESWL
Secondary Time for stone clearance (clinical evaluation)
Secondary Numeric Rating Scale scores at 24h, (48h, if applicable), 72-96h and 7 days
Secondary Need for rescue analgesic medication.
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