- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00336921
Alfuzosin for Treating Acute Urinary Retention
September 14, 2009 updated by: Sanofi
A Double-blind, Randomized,Placebo Controlled Study of Alfuzosin 10mg od in the Return to Successful Voiding in Patients With a First Episode of Acute Urinary Retention Due to Benign Prostatic Hyperplasia
The primary objective of the study is to assess the efficacy of alfuzosin 10mg daily in the return to successful voiding after removal of the catheter following a first episode of acute urinary retention (AUR) in patients suffering from benign prostatic hyperplasia (BPH).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
156
Phase
- Phase 2
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
-
-
-
Beijing, China
- 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
48 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Placebo
|
Once daily
|
Active Comparator: 1
Alfuzosin 10mg
|
Once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events
Time Frame: From the beginning to the end of the study
|
From the beginning to the end of the study
|
Percentage of patients with successful voiding after catheter removal
Time Frame: Day 3 and 4
|
Day 3 and 4
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Bruno Jolain, 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
February 1, 2006
Primary Completion (Actual)
April 1, 2007
Study Registration Dates
First Submitted
June 14, 2006
First Submitted That Met QC Criteria
June 14, 2006
First Posted (Estimate)
June 15, 2006
Study Record Updates
Last Update Posted (Estimate)
September 15, 2009
Last Update Submitted That Met QC Criteria
September 14, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- L_9645
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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