Alfuzosin Versus Placebo in Acute Urinary Retention (ALF-RIK)

August 17, 2007 updated by: Sanofi

Does Alfuzosin OD vs. Placebo in Male Patients Facilitate Spontaneous Voiding During Clean Intermittent Self-Catheterization Following Acute Urinary Retention?

The primary objective of the study is to investigate if 14 days of treatment with Alfuzosin compared to placebo, will increase the number of patients with satisfying spontaneous voiding after acute urinary retention treated with Clean Self-Catheterization.

Furthermore is investigated the safety of the medical treatment and self-catheterization.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hoersholm, Denmark
        • Sanofi-Aventis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Men with acute urinary retention and catheterized
  • Benign hypertrophia of prostate
  • Patient is diagnosed in Emergency room or at a acute hospitalization

Exclusion Criteria:

  • Known prostate cancer
  • Prior urinary retention within 30 days
  • Urinary retention occurring in relation to surgery
  • Blood in urine
  • Difficult or impossible catheterization
  • Fever > 38 degree Celsius
  • Decreased kidney function
  • Permanent catheter > 14 days
  • Treatment with alfa 1 blocker within 30 days
  • Meeting contraindications to treatment with Alfuzosin
  • Treatment with other drugs for urinary problems

The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Number of patients with satisfying spontaneous voiding after 14 days measured by bladder scan at day 14.

Secondary Outcome Measures

Outcome Measure
Number of days until termination of self catheterization
Number of patients with urinary infection requiring treatment
Pressure of voiding, volume of voiding, residual urine after voiding, measured by urine culture and bladder scan at day 14.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Henning Andersen, MD, Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Registration Dates

First Submitted

March 28, 2007

First Submitted That Met QC Criteria

March 28, 2007

First Posted (Estimate)

March 29, 2007

Study Record Updates

Last Update Posted (Estimate)

August 20, 2007

Last Update Submitted That Met QC Criteria

August 17, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L_9397

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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