Urinary RetentionPhase 3ALF-RIKNCT00453908
Alfuzosin Versus Placebo in Acute Urinary Retention
A Phase 3 study testing Alfuzosin in people with Urinary Retention, run by Sanofi at 1 site in Denmark.
Trial summary
The primary objective of the study is to investigate if 14 days of treatment with Alfuzosin compared to placebo, will increase the number of patients with satisfying spontaneous voiding after acute urinary retention treated with Clean Self-Catheterization. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Urinary Retention
- What is being tested?
- Alfuzosin
- How many people
- 160 participants
- Where
- 1 siteDenmark
- Study dates
- May 2004to not given
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men with acute urinary retention and catheterized
- Benign hypertrophia of prostate
- Patient is diagnosed in Emergency room or at a acute hospitalization
Who cannot join
- Known prostate cancer
- Prior urinary retention within 30 days
- Urinary retention occurring in relation to surgery
- Blood in urine
- Difficult or impossible catheterization
- Fever > 38 degree Celsius
Show all 12Show fewer
- Decreased kidney function
- Permanent catheter > 14 days
- Treatment with alfa 1 blocker within 30 days
- Meeting contraindications to treatment with Alfuzosin
- Treatment with other drugs for urinary problems
- The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Alfuzosin OD vs. Placebo in Male Patients Facilitate Spontaneous Voiding During Clean Intermittent Self-Catheterization Following Acute Urinary Retention?
The primary objective of the study is to investigate if 14 days of treatment with Alfuzosin compared to placebo, will increase the number of patients with satisfying spontaneous voiding after acute urinary retention treated with Clean Self-Catheterization.
Furthermore is investigated the safety of the medical treatment and self-catheterization.
- Conditions
- Urinary Retention
- Being tested
- Alfuzosin
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfuzosinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with satisfying spontaneous voiding after 14 days measured by bladder scan at day 14.
Secondary outcomes (3)
Number of days until termination of self catheterization
Number of patients with urinary infection requiring treatment
Pressure of voiding, volume of voiding, residual urine after voiding, measured by urine culture and bladder scan at day 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study startMay 2004
Why it stopped: The study was early terminated due to slow and difficult recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 160 participants
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Henning Andersen, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453908
- Sponsor's protocol ID
- L_9397
- Acronym
- ALF-RIK
- Status last verified
- Aug 2007
- First submitted
- 28 Mar 2007
- Last updated
- 20 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Alfuzosin OD vs. Placebo in Male Patients Facilitate Spontaneous Voiding During Clean Intermittent Self-Catheterization Following Acute Urinary Retention?
- ClinicalTrials.gov ID
- NCT00453908
- Acronym / sponsor ID
- ALF-RIK / L_9397
- Conditions
- Urinary Retention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was early terminated due to slow and difficult recruitment
- Enrolment
- 160 participants
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- May 2004
- First posted
- 29 Mar 2007 (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 investigate if 14 days of treatment with Alfuzosin compared to placebo, will increase the number of patients with satisfying spontaneous voiding after acute urinary retention treated with Clean Self-Catheterization.
Furthermore is investigated the safety of the medical treatment and self-catheterization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men with acute urinary retention and catheterized
- Benign hypertrophia of prostate
- Patient is diagnosed in Emergency room or at a acute hospitalization
Key exclusion criteria (12 listed)
- Known prostate cancer
- Prior urinary retention within 30 days
- Urinary retention occurring in relation to surgery
- Blood in urine
- Difficult or impossible catheterization
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 | Drug | – |
Primary outcome
Number of patients with satisfying spontaneous voiding after 14 days measured by bladder scan at day 14.
3 secondary outcomes
Number of days until termination of self catheterization
Number of patients with urinary infection requiring treatment
Pressure of voiding, volume of voiding, residual urine after voiding, measured by urine culture and bladder scan at day 14.
Results and safety
The study was stopped early (reason given: The study was early terminated due to slow and difficult recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2007.
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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.
Henning Andersen, MD 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 3 study testing Alfuzosin in people with Urinary Retention, run by Sanofi at 1 site in Denmark.
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 3 inclusion and 12 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: stopped early, as of the sponsor's last update on 20 Aug 2007. 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 Denmark. 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 was stopped early (reason given: The study was early terminated due to slow and difficult recruitment). Results are not available in the source record.
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?
Number of patients with satisfying spontaneous voiding after 14 days measured by bladder scan at day 14.. 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 20 Aug 2007.