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ALFAURUS : A DB Randomized Parallel Group Study of Alfuzosin 10mg OD vs Placebo in the Management of AUR in Patients With a 1st Episode Due to BPH

Primary Purpose

Prostatic Hyperplasia, Acute Urinary Retention

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Alfuzosin
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Hyperplasia focused on measuring acute urinary retention, International Prostate Symptom Score (IPSS)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Male aged over 50 years Having given his written consent Presenting with a first episode of painful acute urinary retention related to BPH With a catheterized urine volume between mL and mL at the time of retention Exclusion Criteria: Associated urological diseases / troubles (e.g. infection or surgery of prostate, urinary retention f neurogenic origin Iatrogenic causes of urinary retention

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Successful voiding in initial period (using an active voiding trial)
    No relapse during the 6 month treatment period
    No need / indication for surgery during the initial or 6 month treatment periods

    Secondary Outcome Measures

    To assess the safety of alfuzosin in this population, and health care consumption

    Full Information

    First Posted
    February 9, 2006
    Last Updated
    March 10, 2009
    Sponsor
    Sanofi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00290030
    Brief Title
    ALFAURUS : A DB Randomized Parallel Group Study of Alfuzosin 10mg OD vs Placebo in the Management of AUR in Patients With a 1st Episode Due to BPH
    Official Title
    A Double-Blind Randomized Parallel Group Study of Alfuzosin 10mg OD Versus Placebo in the Management of Acute Urinary Retention in Patients With a First Episode Due to Benign Prostatic Hyperplasia (BPH)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2001 (undefined)
    Primary Completion Date
    October 2004 (Actual)
    Study Completion Date
    October 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sanofi

    4. Oversight

    5. Study Description

    Brief Summary
    To assess the efficacy of alfuzosin 10mg OD in the management of acute urinary retention associated with BPH. To assess the safety of alfuzosin in this population and health care consumption.
    Detailed Description
    Double-blind, placebo controlled, randomized Multicenter, Phase III study comparing 2 parallel groups (alfuzosin 10mg OD or placebo) in patients with a first episode of acute urinary retention related to BPH.The acute episode is managed with catheterization and with study drug treatment for 2 to 3 days, followed by an active voiding trial to assess the patients' ability to void after catheter removal. Those patients who successfully void will continue their randomized treatment for a total treatment duration of 6 months. For all patients who are prematurely withdrawn during the study, a post-study (clinic or phone) visit will be performed for collection of health care consumption data.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostatic Hyperplasia, Acute Urinary Retention
    Keywords
    acute urinary retention, International Prostate Symptom Score (IPSS)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    800 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Alfuzosin
    Primary Outcome Measure Information:
    Title
    Successful voiding in initial period (using an active voiding trial)
    Title
    No relapse during the 6 month treatment period
    Title
    No need / indication for surgery during the initial or 6 month treatment periods
    Secondary Outcome Measure Information:
    Title
    To assess the safety of alfuzosin in this population, and health care consumption

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male aged over 50 years Having given his written consent Presenting with a first episode of painful acute urinary retention related to BPH With a catheterized urine volume between mL and mL at the time of retention Exclusion Criteria: Associated urological diseases / troubles (e.g. infection or surgery of prostate, urinary retention f neurogenic origin Iatrogenic causes of urinary retention
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ICD CSD
    Organizational Affiliation
    Sanofi
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://www.sanofi-aventis.com
    Description
    Related Info

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    ALFAURUS : A DB Randomized Parallel Group Study of Alfuzosin 10mg OD vs Placebo in the Management of AUR in Patients With a 1st Episode Due to BPH

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