NCT00290030

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2001

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2006

Completed
Last Updated

March 12, 2009

Status Verified

March 1, 2009

Enrollment Period

3.4 years

First QC Date

February 9, 2006

Last Update Submit

March 10, 2009

Conditions

Prostatic HyperplasiaAcute Urinary Retention

Keywords

acute urinary retentionInternational Prostate Symptom Score (IPSS)

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

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

Interventions

AlfuzosinDRUG

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Associated urological diseases / troubles (e.g. infection or surgery of prostate, urinary retention f neurogenic origin
  • Iatrogenic causes of urinary retention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

alfuzosin

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • ICD CSD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 9, 2006

First Posted

February 10, 2006

Study Start

May 1, 2001

Primary Completion

October 1, 2004

Study Completion

October 1, 2004

Last Updated

March 12, 2009

Record last verified: 2009-03