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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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00290030
First received: February 9, 2006
Last updated: March 10, 2009
Last verified: March 2009
History of Changes
  Purpose

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 Intervention Phase
Prostatic Hyperplasia
Acute Urinary Retention
 Drug: Alfuzosin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

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
Enrollment: 800
Study Start Date: May 2001
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)
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 For all patients who are prematurely withdrawn during the study, a post-study (clinic or phone) visit will be performed for collection of health care consumption data.

  Eligibility
Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290030

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00290030     History of Changes
Other Study ID Numbers: EFC4428  SL 770499-10 
Study First Received: February 9, 2006
Last Updated: March 10, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
acute urinary retention
International Prostate Symptom Score (IPSS)

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Urinary Retention
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
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

ClinicalTrials.gov processed this record on September 28, 2016