Acute Urinary RetentionPhase 2NCT00336921
Alfuzosin for Treating Acute Urinary Retention
A Phase 2 study testing Alfuzosin in people with Acute Urinary Retention, run by Sanofi at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Acute Urinary Retention
- What is being tested?
- Alfuzosin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- Feb 2006to Apr 2007
- Phase
- Phase 2
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Acute Urinary Retention
- Being tested
- Alfuzosin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfuzosinDrug
Once daily
PlaceboDrug
Once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Alfuzosin 10mg Receives: Drug: Alfuzosin |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with successful voiding after catheter removal
Measured: Day 3 and 4
Adverse events
Measured: From the beginning to the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2006 (estimated)
- Study startFeb 2006
- Primary completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bruno Jolain, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336921
- Sponsor's protocol ID
- L_9645
- Status last verified
- Sep 2009
- First submitted
- 14 Jun 2006
- Last updated
- 15 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00336921
- Acronym / sponsor ID
- L_9645
- Conditions
- Acute Urinary Retention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Feb 2006
- Primary completion
- Apr 2007 (actual)
- First posted
- 15 Jun 2006 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: AlfuzosinAlfuzosin 10mg |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (27 listed)
- 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;
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 |
|---|---|---|
| AlfuzosinOnce daily | Drug | 1 |
| PlaceboOnce daily | Drug | 2 |
Primary outcome
Percentage of patients with successful voiding after catheter removal
Time frame: Day 3 and 4
Adverse events
Time frame: From the beginning to the end of the study
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 15 Sep 2009.
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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.
Bruno Jolain study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alfuzosin in people with Acute Urinary Retention, run by Sanofi at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 27 exclusion criteria. 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 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percentage of patients with successful voiding after catheter removal (time frame: Day 3 and 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2009.