ALFAURUS : A DB Randomized Parallel Group Study of Alfuzosin 10mg OD vs Placebo in the Management of AUR in Patients With a 1st Episode Due to BPH
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostatic Hyperplasia Acute Urinary Retention |
Drug: Alfuzosin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Double-Blind Randomized Parallel Group Study of Alfuzosin 10mg OD Versus Placebo in the Management of Acute Urinary Retention in Patients With a First Episode Due to Benign Prostatic Hyperplasia (BPH) |
- 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
- To assess the safety of alfuzosin in this population, and health care consumption
| Enrollment: | 800 |
| Study Start Date: | May 2001 |
| Study Completion Date: | October 2004 |
| Primary Completion Date: | October 2004 (Final data collection date for primary outcome measure) |
Double-blind, placebo controlled, randomized Multicenter, Phase III study comparing 2 parallel groups (alfuzosin 10mg OD or placebo) in patients with a first episode of acute urinary retention related to BPH.The acute episode is managed with catheterization and with study drug treatment for 2 to 3 days, followed by an active voiding trial to assess the patients' ability to void after catheter removal.
Those patients who successfully void will continue their randomized treatment for a total treatment duration of 6 months. For all patients who are prematurely withdrawn during the study, a post-study (clinic or phone) visit will be performed for collection of health care consumption data.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Associated urological diseases / troubles (e.g. infection or surgery of prostate, urinary retention f neurogenic origin
- Iatrogenic causes of urinary retention
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | ICD Study Director, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00290030 History of Changes |
| Other Study ID Numbers: | EFC4428, SL 770499-10 |
| Study First Received: | February 9, 2006 |
| Last Updated: | March 10, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
acute urinary retention International Prostate Symptom Score (IPSS) |
Additional relevant MeSH terms:
|
Prostatic Hyperplasia Hyperplasia Urinary Retention Prostatic Diseases Genital Diseases, Male Pathologic Processes Urination Disorders Urologic Diseases Alfuzosin Antihypertensive Agents |
Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013