Prostatic HyperplasiaPhase 3NCT00454402
ALF-STONE: Alfuzosin in Uretheric Stones
A Phase 3 study testing Alfuzosin in people with Prostatic Hyperplasia, run by Sanofi at 1 site in Portugal.
Trial summary
The aim of the study is to assess the effect of Alfuzosin compared with placebo, for 7 days, on the outcome of patients with uretheric stones submitted to Extracorporeal Shock Wave Lithotripsy (ESWL), namely in the percentage of patients without imagiologic evidence of any stone after 72h to 96 hours. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Alfuzosin
- How many people
- 220 participants
- Where
- 1 sitePortugal
- Study dates
- Aug 2006to Jul 2007
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with imagiologic evidence of uretheric stones
Who cannot join
- Women pregnant or breast feeding
- Patients with renal impairment (creatinine > 2mg/dl)
- 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: Alfuzosin in Uretheric Stones
The aim of the study is to assess the effect of Alfuzosin compared with placebo, for 7 days, on the outcome of patients with uretheric stones submitted to Extracorporeal Shock Wave Lithotripsy (ESWL), namely in the percentage of patients without imagiologic evidence of any stone after 72h to 96 hours.
This study will also specifically focus on the evaluation of time of stone clearance and of pain reduction (Numeric Rating Scale).
- Conditions
- Prostatic Hyperplasia
- Being tested
- Alfuzosin
- Medical subject headings
- Prostatic Hyperplasia
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.
Safety: General clinical safety by collection of spontaneously reported adverse events
Measured: at each visit
Efficacy: Percentage of patients without imagiologic evidence of any stone
Measured: 72h to 96 hours after ESWL
Secondary outcomes (5)
Percentage of patients without imagiologic evidence of any stone
Measured: 24 hours after ESWL
Percentage of patients with clinical evidence of stones clearance
Measured: 72h to 96 hours after ESWL
Time for stone clearance (clinical evaluation)
Numeric Rating Scale scores
Measured: at 24h, (48h, if applicable), 72-96h and 7 days
Need for rescue analgesic medication.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2007 (estimated)
- Study startAug 2006
- Study completionJul 2007
Why it stopped: Discontinued due to incomplete recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies 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
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Carlos Santos, MD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454402
- Sponsor's protocol ID
- L_9795
- Other IDs
- EudraCT # : 2005-005481-36
- Status last verified
- Sep 2007
- First submitted
- 29 Mar 2007
- Last updated
- 24 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alfuzosin in Uretheric Stones
- ClinicalTrials.gov ID
- NCT00454402
- Acronym / sponsor ID
- L_9795
- Conditions
- Prostatic Hyperplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Discontinued due to incomplete recruitment
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 30 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 aim of the study is to assess the effect of Alfuzosin compared with placebo, for 7 days, on the outcome of patients with uretheric stones submitted to Extracorporeal Shock Wave Lithotripsy (ESWL), namely in the percentage of patients without imagiologic evidence of any stone after 72h to 96 hours.
This study will also specifically focus on the evaluation of time of stone clearance and of pain reduction (Numeric Rating Scale).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with imagiologic evidence of uretheric stones
Key exclusion criteria (3 listed)
- Women pregnant or breast feeding
- Patients with renal impairment (creatinine > 2mg/dl)
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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
Safety: General clinical safety by collection of spontaneously reported adverse events
Time frame: at each visit
Efficacy: Percentage of patients without imagiologic evidence of any stone
Time frame: 72h to 96 hours after ESWL
5 secondary outcomes
Percentage of patients without imagiologic evidence of any stone
Time frame: 24 hours after ESWL
Percentage of patients with clinical evidence of stones clearance
Time frame: 72h to 96 hours after ESWL
Time for stone clearance (clinical evaluation)
Numeric Rating Scale scores
Time frame: at 24h, (48h, if applicable), 72-96h and 7 days
Need for rescue analgesic medication.
Results and safety
The study was stopped early (reason given: Discontinued due to incomplete recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 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.
Carlos Santos, 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 Prostatic Hyperplasia, run by Sanofi at 1 site in Portugal.
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 1 inclusion and 3 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 24 Sep 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 Portugal. 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: Discontinued due to incomplete 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?
Safety: General clinical safety by collection of spontaneously reported adverse events (time frame: at each visit). 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 24 Sep 2007.