Urinary RetentionPhase 3NCT00029822
Clinical Trial in Males With BPH (Enlarged Prostate)
A Phase 3 study testing Alfuzosin (SL770499) in people with Urinary Retention and Prostatic Hyperplasia, run by Sanofi at 54 sites in 17 countries.
Trial summary
A study to determine the effect on prevention of Acute Urinary Retention (inability to urinate) in males with an enlarged prostate, also known as BPH. Free study-related medical care provided. Read more about this study
- Who is it for?
- Ages 55 years and older, men only
- Conditions the study is for
- Urinary Retention, Prostatic Hyperplasia, Benign Prostatic Hypertrophy
- What is being tested?
- Alfuzosin (SL770499)
- How many people
- 1,522 participants
- Where
- 54 sitesin 17 countries
- Study dates
- May 2001to Mar 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
- Has been suffering for at least 6 months with any of the following symptoms:
- daytime or nighttime urinary frequency
- urgent feeling to urinate
- difficulty starting urinary stream
- interruption of urinary stream
- feeling of incomplete urination
- Has not had a previous episode of acute urinary retention
- Has not been diagnosed with prostate cancer
- Has not had previous prostate surgery
- Is not an insulin-dependent diabetic
Trial locations and contacts
54 sites in 17 countries.
54 sites in 17 countries
United States35 sites
Urology Research Options
Aurora, Colorado, 80012
South Florida Medical Research
Aventura, Florida, 33180
Maryland Prostate Cancer
Baltimore, Maryland, 21201
Northwestern Center for Clinical Research
Chicago, Illinois, 60611
Tampa Bay Medical Research, Inc.
Clearwater, Florida, 34621
nTouch Research Corporation
Dallas, Texas, 75230
Advanced Clinical Trials
Eugene, Oregon, 97401
Welborn Clinic
Evansville, Indiana, 47714
Northeast Indiana Research
Fort Wayne, Indiana, 46804-4128
Urology Associates
Fredericksburg, Virginia, 22401
Matrix Research
Greenville, South Carolina, 29650
Medical Affiliated Research Center, Inc
Huntsville, Alabama, 35801
Urology of Indiana, LLC
Indianapolis, Indiana, 46202
San Diego Urology Center
La Mesa, California, 91942
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53792
Urology Associates
Marietta, Georgia, 30060
Ut Medical Group, Inc.
Memphis, Tennessee, 38103-3446
Midwest Research Specialists, LLC
Milwaukee, Wisconsin, 53209
Murfreesboro Medical Center
Murfreesboro, Tennessee, 37130
Advanced Research Institute
New Port Richey, Florida, 34652
Weill Cornell Medical Center
New York, New York, 10021
Newton Wellesley Urology
Newton, Massachusetts, 02462
Renstar Medical Research
Ocala, Florida, 34474
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Renstar Medical Research
Plantation, Florida, 33324
Lakeside Urology, P.C.
Saint Joseph, Michigan, 49085-2521
Urology Consultants, P.A.
San Antonio, Texas, 78229
San Bernardino Urology Associates
San Bernardino, California, 92404
San Diego Urological Medical Group
San Diego, California, 92101
Pacific Clinical Research
Santa Monica, California, 90404
Jeffrey Frankel
Seattle, Washington, 98166-3059
Se Urology Network
Southaven, Mississippi, 38671
Maryland Urology Association
Towson, Maryland, 21204
Connecticut Clinical Research Center
Waterbury, Connecticut, 06708-2652
Center for Urologic Care
West Reading, Pennsylvania, 19611
Israel4 sites
Edith Wolfson Hospital
Holon, 58100
Sapir Med. Center - Meir General Hospital
Kfar Saba, 44281
Rabin Medical Center-Golda Campus
Petah Tikvah, 44281
Sourasky Med. Center-Ichilov Hospital
Tel Aviv, 44281
About this study
Official title: Long-Term, Efficacy and Safety of Alfuzosin 10 MG OD on the Risk of Acute Urinary Retention and the Need for Surgery in Patients With BPH. A Two Year, Randomized, Multicenter, Double-Blind, Parallel Group, Placebo-Controlled Study.
A study to determine the effect on prevention of Acute Urinary Retention (inability to urinate) in males with an enlarged prostate, also known as BPH.
- Free study-related medical care provided.
- Being tested
- Alfuzosin (SL770499)
- Keywords
- Acute Urinary Retention, AUR, Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy, BPH, Enlarged Prostate
- Medical subject headings
- Urinary Retention, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alfuzosin (SL770499)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of first episode of acute urinary retention (AUR)
Secondary outcomes (1)
need for benign prostatic hyperplasia (BPH)-related surgery, international prostate symptoms score (IPSS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2002 (estimated)
- Study startMay 2001
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary RetentionStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,522 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029822
- Sponsor's protocol ID
- EFC4485
- Other IDs
- SL770499
- Status last verified
- Jun 2008
- First submitted
- 23 Jan 2002
- Last updated
- 9 Jun 2008
- Results posted
- No
Publications
Roehrborn CG. Alfuzosin 10 mg once daily prevents overall clinical progression of benign prostatic hyperplasia but not acute urinary retention: results of a 2-year placebo-controlled study. BJU Int. 2006 Apr;97(4):734-41. doi: 10.1111/j.1464-410X.2006.06110.x.
PubMed 16536764
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term, Efficacy and Safety of Alfuzosin 10 MG OD on the Risk of Acute Urinary Retention and the Need for Surgery in Patients With BPH. A Two Year, Randomized, Multicenter, Double-Blind, Parallel Group, Placebo-Controlled Study.
- ClinicalTrials.gov ID
- NCT00029822
- Acronym / sponsor ID
- EFC4485
- Keywords
- Acute Urinary Retention, AUR, Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy, BPH, Enlarged Prostate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,522 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2001
- Study completion
- Mar 2005 (actual)
- First posted
- 24 Jan 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to determine the effect on prevention of Acute Urinary Retention (inability to urinate) in males with an enlarged prostate, also known as BPH.
- Free study-related medical care provided.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 55 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alfuzosin (SL770499) | Drug | – |
Primary outcome
occurrence of first episode of acute urinary retention (AUR)
1 secondary outcome
need for benign prostatic hyperplasia (BPH)-related surgery, international prostate symptoms score (IPSS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2008.
- Results publication: PubMed 16536764Roehrborn CG. Alfuzosin 10 mg once daily prevents overall clinical progression of benign prostatic hyperplasia but not acute urinary retention: results of a 2-year placebo-controlled study. BJU Int. 2006 Apr;97(4):734-41. doi: 10.1111/j.1464-410X.2006.06110.x.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ICD CSD study director
Sanofi
54 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alfuzosin (SL770499) in people with Urinary Retention and Prostatic Hyperplasia, run by Sanofi at 54 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Israel, Australia, Bulgaria, Canada and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
occurrence of first episode of acute urinary retention (AUR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00029822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2008.