Alfuzosin Versus Placebo in Acute Urinary Retention | NCT00453908

Studies
Alfuzosin Versus Placebo in Acute Urinary Retention

NCT00453908

Sponsor

Sanofi

Status

Terminated

Last Update Posted

Aug 20, 2007Estimated

Enrollment

160

Phase

Phase 3

Conditions

Urinary Retention

Interventions

Alfuzosin

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was early terminated due to slow and difficult recruitment

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 28, 2007

First Submission Date that Met QC Criteria

Mar 28, 2007

First Posted Date

Mar 29, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2007

Last Update Posted Date

Aug 20, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

160

Name	Type	Description	Arm Group Labels	Other Names
Alfuzosin	Drug

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Henning Andersen, MD	Sanofi	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D016055	Urinary Retention

Ancestor Terms

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided