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NCT00290030 Clinical Trial

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

Prostatic Hyperplasia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00290030
Other study ID # EFC4428
Secondary ID SL 770499-10
Status Completed
Phase Phase 3
First received February 9, 2006
Last updated March 10, 2009
Start date May 2001
Est. completion date October 2004

Study information
Verified date March 2009
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

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 For all patients who are prematurely withdrawn during the study, a post-study (clinic or phone) visit will be performed for collection of health care consumption data.

Recruitment information / eligibility
Status Completed
Enrollment 800
Est. completion date October 2004
Est. primary completion date October 2004
Accepts healthy volunteers No
Gender Male
Age group 50 Years and older
Eligibility 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

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
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sanofi

Outcome
Type Measure Description Time frame Safety issue
Primary Successful voiding in initial period (using an active voiding trial)
Primary No relapse during the 6 month treatment period
Primary No need / indication for surgery during the initial or 6 month treatment periods
Secondary To assess the safety of alfuzosin in this population, and health care consumption
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