ALF-STONE: Alfuzosin in Uretheric Stones

September 21, 2007 updated by: Sanofi

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisbon, Portugal
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety: General clinical safety by collection of spontaneously reported adverse events
Time Frame: at each visit
at each visit
Efficacy: Percentage of patients without imagiologic evidence of any stone
Time Frame: 72h to 96 hours after ESWL
72h to 96 hours after ESWL

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients without imagiologic evidence of any stone
Time Frame: 24 hours after ESWL
24 hours after ESWL
Percentage of patients with clinical evidence of stones clearance
Time Frame: 72h to 96 hours after ESWL
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
at 24h, (48h, if applicable), 72-96h and 7 days
Need for rescue analgesic medication.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Carlos Santos, MD, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Study Completion (ACTUAL)

July 1, 2007

Study Registration Dates

First Submitted

March 29, 2007

First Submitted That Met QC Criteria

March 29, 2007

First Posted (ESTIMATE)

March 30, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

September 24, 2007

Last Update Submitted That Met QC Criteria

September 21, 2007

Last Verified

September 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L_9795
  • EudraCT # : 2005-005481-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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