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Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction (ALFACHIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00549939
Recruitment Status : Completed
First Posted : October 26, 2007
Results First Posted : February 8, 2011
Last Update Posted : October 29, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE October 25, 2007
First Posted Date  ICMJE October 26, 2007
Results First Submitted Date  ICMJE January 13, 2011
Results First Posted Date  ICMJE February 8, 2011
Last Update Posted Date October 29, 2014
Study Start Date  ICMJE October 2007
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2010)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2007)
Detrusor leak point pressure (LPP) [ Time Frame: after 12 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 15, 2011)
  • Detrusor Leak Point Pressure (LPP) [ Time Frame: baseline and 12 weeks (double blind treatment period) ]
    Detrusor Leak Point Pressure (LPP) was assessed at baseline and 12 weeks as described for the primary outcome measure.
  • Absolute Change in Detrusor LPP [ Time Frame: 12 weeks ((double blind treatment period) ]
    Absolute change = Detrusor LPP at 12 weeks - Detrusor LPP at baseline
  • Relative Change in Detrusor LPP [ Time Frame: 12 weeks (double blind treatment period) ]
    Relative change = 100 * (Detrusor LPP at 12 weeks - Detrusor LPP at baseline) / Detrusor LPP at baseline
  • Detrusor Compliance [ Time Frame: baseline and 12 weeks (double blind treatment period) ]
    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).
  • Relative Change in Detrusor Compliance [ Time Frame: 12 weeks (double blind treatment period) ]
    Relative change = 100 * (Detrusor compliance at 12 weeks - Detrusor compliance at baseline) / Detrusor compliance at baseline
  • Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes [ Time Frame: 12 weeks (double blind treatment period) ]
    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.
  • Number of Participants With Symptomatic Urinary Tract Infection (UTI) Episodes [ Time Frame: 52 weeks (double blind treatment period + open label extension treatment period) ]
    Symptomatic UTI episodes were assessed similar to the previous outcome measure but for a longer follow-up period.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2007)
  • Relative change in detrusor LPP and relative change in detrusor compliance [ Time Frame: after 12 weeks ]
  • Number of documented urinary tract infections [ Time Frame: 12 weeks ]
  • Pharmacokinetics of alfuzosin [ Time Frame: 52 weeks ]
  • Safety of alfuzosin [ Time Frame: 52 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction
Official Title  ICMJE 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
Brief 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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neurogenic Urinary Bladder
Intervention  ICMJE
  • Drug: Alfuzosin

    Form: solution or tablet according to age

    Route: oral

    Dose: daily dose adjusted to body weight

    Other Name: SL770499
  • Drug: Placebo

    Form: matching solution or matching tablet according to age

    Route: oral

    Dose: daily dose adjusted to body weight

Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Matching placebo 0.1 mg/kg/day or 0.2 mg/kg/day
    Intervention: Drug: Placebo
  • Experimental: Alfuzosin 0.1 mg/kg/day
    Intervention: Drug: Alfuzosin
  • Experimental: Alfuzosin 0.2 mg/kg/day
    Intervention: Drug: Alfuzosin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 17, 2010)
172
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2007)
150
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient with elevated detrusor Leak Point Pressure (LPP) of neuropathic etiology and Detrusor LPP ≥ 40 cm H2O and < 100 cm H2O.

Exclusion Criteria:

  • 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,
  • 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Canada,   Estonia,   France,   Germany,   India,   Malaysia,   Philippines,   Poland,   Portugal,   Russian Federation,   Serbia,   Singapore,   Slovakia,   Spain,   Taiwan,   Turkey,   United States
Removed Location Countries Former Serbia and Montenegro
 
Administrative Information
NCT Number  ICMJE NCT00549939
Other Study ID Numbers  ICMJE EFC5722
2004-002397-38 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ICD CSD Sanofi
PRS Account Sanofi
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP