Neurogenic Urinary BladderPhase 3ALFACHINNCT00549939
Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction
A Phase 3 study testing Alfuzosin in people with Neurogenic Urinary Bladder, run by Sanofi at 18 sites in 18 countries.
Trial summary
The primary objective of the study was to evaluate the efficacy of Alfuzosin in comparison to Placebo on the detrusor Leak Point Pressure (LPP) in children and adolescents 2-16 years of age with elevated detrusor LPP of neuropathic etiology and detrusor LPP ≥ 40 cm H2O. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Neurogenic Urinary Bladder
- What is being tested?
- Alfuzosin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 172 participants
- Where
- 18 sitesin 18 countries
- Study dates
- Oct 2007to Dec 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient with elevated detrusor Leak Point Pressure (LPP) of neuropathic etiology and Detrusor LPP ≥ 40 cm H2O and < 100 cm H2O.
Who cannot join
- Urological surgery in the last 4 months prior to the study,
- Patients who have urethral dilatation in the last 3 months prior to the baseline urodynamic assessment,
- α-blocker therapy in the last 4 weeks prior to the baseline urodynamic assessment,
- Detrusor injections of botulinum toxin in the last 6 months,
- Urological diseases/conditions other than functional bladder obstruction of neuropathic etiology that can lead to upper urinary tract dilatation (e.g., bladder anomalies, ureterocele),
- History of intolerance to α-blocker therapy,
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- Orthostatic hypotension,
- History of risk factors for Torsade de pointes (e.g., family history of Long QT Syndrome).
- 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
18 sites in 18 countries.
18 sites in 18 countries
United States1 site
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, 08807
About this study
Official title: 12-week, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy, Pharmacodynamic and Safety of 2 Doses of Alfuzosin (0.1 mg/kg/Day, 0.2 mg/kg/Day) in the Treatment of Children and Adolescents 2-16 Years With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology Followed by a 40-week Open-label Extension
The primary objective of the study was to evaluate the efficacy of Alfuzosin in comparison to Placebo on the detrusor Leak Point Pressure (LPP) in children and adolescents 2-16 years of age with elevated detrusor LPP of neuropathic etiology and detrusor LPP ≥ 40 cm H2O.
Secondary objectives were:
Read more
- To investigate the safety and tolerability of two doses of Alfuzosin in comparison to Placebo in children and adolescents,
- To evaluate the effects of the two doses of Alfuzosin in comparison to Placebo on:
- Detrusor compliance,
- Urinary tract infection,
- To investigate the pharmacokinetics of Alfuzosin (population kinetics),
- To evaluate the 12-month long-term safety of Alfuzosin 0.1 mg/kg/day and 0.2 mg/kg/day.
The study consisted of 2 periods:
- a 12-week double blind treatment period where patients were to receive either Alfuzosin 0.1 mg/kg/day or Alfuzosin 0.2 mg/kg/day or placebo then,
- a 40-week open label extension treatment period where patients were to receive either Alfuzosin 0.1 mg/kg/day or Alfuzosin 0.2 mg/kg/day.
Read the detailed description
Patients who met the study entry criteria were randomized (2:1:2:1) to one of the 4 dosage groups (Alfuzosin 0.1 mg/kg/day, matching placebo 0.1 mg/kg/day, Alfuzosin 0.2 mg/mg/kg, matching placebo 0.2 mg/kg/day).
Patients received their treatment using either solution or tablet formulation depending on age as follows:
- Solution to children 2-7 years of age or, children and adolescents 8-16 years of age if they were unable to swallow tablets or they preferred to take the solution or if they had a body weight < 30kg. The daily dose was devided in 3 doses given at at breakfast, lunch and dinner.
- Tablet to children and adolescents 8-16 years of age who were able to swallow tablets and had a body weight ≥ 30kg. The daily dose was devided in 2 doses given at at breakfast and dinner.
Patients who have completed the 12-week double-blind phase were offered to continue in the 40-week open-label extension study.
- Patients receiving Alfuzosin continued with their dosing regimen.
- Patients receiving Placebo were switched to Alfuzosin with a dose corresponding to their randomization dose group.
All patients had a one-week follow-up period after last dose intake.
- Conditions
- Neurogenic Urinary Bladder
- Being tested
- Alfuzosin, Placebo
- Keywords
- child, bladder, neuropathic, alpha blockers
- Medical subject headings
- Urinary Bladder, Neurogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlfuzosinDrug
Also called SL770499
Form: solution or tablet according to age
Route: oral
Dose: daily dose adjusted to body weight
PlaceboDrug
Form: matching solution or matching tablet according to age
Route: oral
Dose: daily dose adjusted to body weight
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matching placebo 0.1 mg/kg/day or 0.2 mg/kg/day Receives: Drug: Placebo |
| Alfuzosin 0.1 mg/kg/day | Experimental | Not described Receives: Drug: Alfuzosin |
| Alfuzosin 0.2 mg/kg/day | Experimental | Not described Receives: Drug: Alfuzosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O
Detrusor Leak Point Pressure (LPP) was measured by cystometry.
For each measure, 2 or 3 cystometries were carried out depending on the difference between the 2 first LPP values (if the difference ≥ 20 cm H2O, a 3rd cystometry was done). The lowest value was retained.
Investigators reading was then consolidated by the review of all cystometry data by 2 external "Expert Reviewers", who were blinded for the study treatment.
The analysis was performed on consolidated investigators data (i.e. endorsed by the Investigator taking into account reviewers opinion).
Measured: 12 weeks (double blind treatment period)
Secondary outcomes (7)
Detrusor Leak Point Pressure (LPP)
Detrusor Leak Point Pressure (LPP) was assessed at baseline and 12 weeks as described for the primary outcome measure.
Measured: baseline and 12 weeks (double blind treatment period)
Absolute Change in Detrusor LPP
Absolute change = Detrusor LPP at 12 weeks - Detrusor LPP at baseline
Measured: 12 weeks ((double blind treatment period)
Relative Change in Detrusor LPP
Relative change = 100 * (Detrusor LPP at 12 weeks - Detrusor LPP at baseline) / Detrusor LPP at baseline
Measured: 12 weeks (double blind treatment period)
Detrusor Compliance
Detrusor compliance is defined as the relationship between change in detrusor volume and change in detrusor pressure.
It was calculated by dividing the volume change (ΔV) by the change in detrusor pressure (Δpdet) during that change in detrusor volume at leak point (C= ΔV/Δpdet).
Measured: baseline and 12 weeks (double blind treatment period)
Relative Change in Detrusor Compliance
Relative change = 100 * (Detrusor compliance at 12 weeks - Detrusor compliance at baseline) / Detrusor compliance at baseline
Measured: 12 weeks (double blind treatment period)
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes
When a patient presented with symptoms such as pain, fever or hematuria (discretion of the Investigator), an urinalysis was performed including a dipstick and a quantitative urine culture.
A symptomatic UTI was defined as the presence of symptoms and a positive culture with > 100 000 Colony Forming Units (CFUs) with a single organism.
Measured: 12 weeks (double blind treatment period)
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes
Symptomatic UTI episodes were assessed similar to the previous outcome measure but for a longer follow-up period.
Measured: 52 weeks (double blind treatment period + open label extension treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2007 (estimated)
- Study startOct 2007
- Primary completionMar 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neurogenic Urinary BladderStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ICD CSD, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549939
- Sponsor's protocol ID
- EFC5722
- Other IDs
- 2004-002397-38, 2004
- Acronym
- ALFACHIN
- Status last verified
- Oct 2014
- First submitted
- 25 Oct 2007
- Last updated
- 29 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 12-week, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy, Pharmacodynamic and Safety of 2 Doses of Alfuzosin (0.1 mg/kg/Day, 0.2 mg/kg/Day) in the Treatment of Children and Adolescents 2-16 Years With Elevated Detrusor Leak Point Pressure of Neuropathic Etiology Followed by a 40-week Open-label Extension
- ClinicalTrials.gov ID
- NCT00549939
- Acronym / sponsor ID
- ALFACHIN / EFC5722
- Conditions
- Neurogenic Urinary Bladder
- Keywords
- child, bladder, neuropathic, alpha blockers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Oct 2007 (estimated)
- Results
- Posted 8 Feb 2011
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 was to evaluate the efficacy of Alfuzosin in comparison to Placebo on the detrusor Leak Point Pressure (LPP) in children and adolescents 2-16 years of age with elevated detrusor LPP of neuropathic etiology and detrusor LPP ≥ 40 cm H2O.
Secondary objectives were:
- To investigate the safety and tolerability of two doses of Alfuzosin in comparison to Placebo in children and adolescents,
- To evaluate the effects of the two doses of Alfuzosin in comparison to Placebo on:
- Detrusor compliance,
- Urinary tract infection,
- To investigate the pharmacokinetics of Alfuzosin (population kinetics),
- To evaluate the 12-month long-term safety of Alfuzosin 0.1 mg/kg/day and 0.2 mg/kg/day.
The study consisted of 2 periods:
- a 12-week double blind treatment period where patients were to receive either Alfuzosin 0.1 mg/kg/day or Alfuzosin 0.2 mg/kg/day or placebo then,
- a 40-week open label extension treatment period where patients were to receive either Alfuzosin 0.1 mg/kg/day or Alfuzosin 0.2 mg/kg/day.
Detailed description
Patients who met the study entry criteria were randomized (2:1:2:1) to one of the 4 dosage groups (Alfuzosin 0.1 mg/kg/day, matching placebo 0.1 mg/kg/day, Alfuzosin 0.2 mg/mg/kg, matching placebo 0.2 mg/kg/day).
Patients received their treatment using either solution or tablet formulation depending on age as follows:
- Solution to children 2-7 years of age or, children and adolescents 8-16 years of age if they were unable to swallow tablets or they preferred to take the solution or if they had a body weight < 30kg. The daily dose was devided in 3 doses given at at breakfast, lunch and dinner.
- Tablet to children and adolescents 8-16 years of age who were able to swallow tablets and had a body weight ≥ 30kg. The daily dose was devided in 2 doses given at at breakfast and dinner.
Patients who have completed the 12-week double-blind phase were offered to continue in the 40-week open-label extension study.
- Patients receiving Alfuzosin continued with their dosing regimen.
- Patients receiving Placebo were switched to Alfuzosin with a dose corresponding to their randomization dose group.
All patients had a one-week follow-up period after last dose intake.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo 0.1 mg/kg/day or 0.2 mg/kg/day |
| Alfuzosin 0.1 mg/kg/day | Experimental | Drug: Alfuzosin |
| Alfuzosin 0.2 mg/kg/day | Experimental | Drug: Alfuzosin |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patient with elevated detrusor Leak Point Pressure (LPP) of neuropathic etiology and Detrusor LPP ≥ 40 cm H2O and < 100 cm H2O.
Key exclusion criteria (9 listed)
- Urological surgery in the last 4 months prior to the study,
- Patients who have urethral dilatation in the last 3 months prior to the baseline urodynamic assessment,
- α-blocker therapy in the last 4 weeks prior to the baseline urodynamic assessment,
- Detrusor injections of botulinum toxin in the last 6 months,
- Urological diseases/conditions other than functional bladder obstruction of neuropathic etiology that can lead to upper urinary tract dilatation (e.g., bladder anomalies, ureterocele),
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 |
|---|---|---|
| AlfuzosinAlso: SL770499Form: solution or tablet according to age Route: oral Dose: daily dose adjusted to body weight | Drug | Alfuzosin 0.1 mg/kg/day, Alfuzosin 0.2 mg/kg/day |
| PlaceboForm: matching solution or matching tablet according to age Route: oral Dose: daily dose adjusted to body weight | Drug | Placebo |
Primary outcome
Number of Patients With Detrusor Leak Point Pressure (LPP) < 40 cm H2O
Time frame: 12 weeks (double blind treatment period)
Detrusor Leak Point Pressure (LPP) was measured by cystometry. For each measure, 2 or 3 cystometries were carried out depending on the difference between the 2 first LPP values (if the difference ≥ 20 cm H2O, a 3rd cystometry was done). The lowest value was retained. Investigators reading was then consolidated by the review of all cystometry data by 2 external "Expert Reviewers", who were blinded for the study treatment. The analysis was performed on consolidated investigators data (i.e. endorsed by the Investigator taking into account reviewers opinion).
7 secondary outcomes
Detrusor Leak Point Pressure (LPP)
Time frame: baseline and 12 weeks (double blind treatment period)
Absolute Change in Detrusor LPP
Time frame: 12 weeks ((double blind treatment period)
Relative Change in Detrusor LPP
Time frame: 12 weeks (double blind treatment period)
Detrusor Compliance
Time frame: baseline and 12 weeks (double blind treatment period)
Relative Change in Detrusor Compliance
Time frame: 12 weeks (double blind treatment period)
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes
Time frame: 12 weeks (double blind treatment period)
Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes
Time frame: 52 weeks (double blind treatment period + open label extension treatment period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
18 sites in 18 countries: 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 Neurogenic Urinary Bladder, run by Sanofi at 18 sites in 18 countries.
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 9 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 29 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Bulgaria, Canada, Estonia, France and 13 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. 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 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?
Yes. Results are posted in the registry (first posted 8 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Detrusor Leak Point Pressure (LPP) < 40 cm H2O (time frame: 12 weeks (double blind treatment period)). 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 29 Oct 2014.