Alfuzosin for Treating Acute Urinary Retention | NCT00336921

Studies
Alfuzosin for Treating Acute Urinary Retention

NCT00336921

Sponsor

Sanofi

Status

Completed

Last Update Posted

Sep 15, 2009Estimated

Enrollment

156Actual

Phase

Phase 2

Conditions

Acute Urinary Retention

Interventions

Alfuzosin
Placebo

Countries

China

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

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Apr 2007Actual

Completion Date

Not provided

First Submitted Date

Jun 14, 2006

First Submission Date that Met QC Criteria

Jun 14, 2006

First Posted Date

Jun 15, 2006Estimated

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

Sep 14, 2009

Last Update Posted Date

Sep 15, 2009Estimated

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

156Actual

Label	Type	Description	Intervention Names
1	Active Comparator	Alfuzosin 10mg	Drug: Alfuzosin
2	Placebo Comparator	Placebo	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Alfuzosin	Drug	Once daily	1
Placebo

Measure	Description	Time Frame
Percentage of patients with successful voiding after catheter removal		Day 3 and 4
Adverse events		From the beginning to the end of the study

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

First episode of painful AUR related to BPH requiring catheterization
Residual volume between 500ml and 1500ml obtained at the time of catheterization and during the first one hour after catheterization

Exclusion Criteria:

Participated in another investigational study within 3 months before recruitment
Suspect bladder neuro-dysfunction unrelated to etiology;
Single Bladder neck disease;
Acute/chronic prostatitis;
Diagnosed prostate carcinoma;
Suspected prostate carcinoma diagnosed by ultrasound wave;
Surgical history of prostate and urethra;
Diagnosed/suspected abnormality in urethra structure;
Bladder stone;
Blood urine retention caused by any reason;
Residual volume less than 500 ml
Residual volume more than 1500 ml
AUR not due to BPH
Parkinson's disease
Insulin dependent diabetes
Known/suspected multiple sclerosis;
Stroke/MI within 6 months prior to enrolment;
AST, ALT and Creatinine > 1.5x upper limit; neutrophil < 3,000/mm³; platelet < 100,000/mm³;
Unstable/severe heart failure;
History of postural hypertension/hypotension;
Known hypersensitivity to α-receptor blocker;
Suspected/diagnosed expansible nerval disease;
Treatment with sympathomimetic agent within 1 week prior to enrolment, except OTC drug for cold intermittently;
Treatment with α1-receptor blocker within 1 month prior to enrolment;
Treatment with tricyclic antidepressants, anticholinergic agents, sympathomimetic agent (other than the above reason), first generation antihistaminic, except the treatment with stable β sympathomimetic agent/ anticholinergic agents lasting more than 1 week for Asthma and COPD (Chronic Obstructive Pulmonary Disease);
Treatment with Disopyramide

The above information is not intended to contain all considerations relevant to a patient's 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

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided