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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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ClinicalTrials.gov Identifier: NCT00290030
Recruitment Status : Completed
First Posted : February 10, 2006
Last Update Posted : March 12, 2009
Sponsor:
Information provided by:
Sanofi

Study Description
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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.


Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia Acute Urinary Retention Drug: Alfuzosin Phase 3

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 For all patients who are prematurely withdrawn during the study, a post-study (clinic or phone) visit will be performed for collection of health care consumption data.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2001
Actual Primary Completion Date : October 2004
Actual Study Completion Date : October 2004

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Successful voiding in initial period (using an active voiding trial)
  2. No relapse during the 6 month treatment period
  3. No need / indication for surgery during the initial or 6 month treatment periods

Secondary Outcome Measures :
  1. To assess the safety of alfuzosin in this population, and health care consumption

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290030


Sponsors and Collaborators
Sanofi
Investigators
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Study Director: ICD CSD Sanofi
More Information
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Additional Information:

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Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00290030    
Other Study ID Numbers: EFC4428
SL 770499-10
First Posted: February 10, 2006    Key Record Dates
Last Update Posted: March 12, 2009
Last Verified: March 2009
Keywords provided by Sanofi:
acute urinary retention
International Prostate Symptom Score (IPSS)
Additional relevant MeSH terms:
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Prostatic Hyperplasia
Urinary Retention
Hyperplasia
Pathologic Processes
Prostatic Diseases
Urination Disorders
Urologic Diseases
Alfuzosin
 Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents