Ignite Creation Date:
2024-05-05 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00549939
Status:
COMPLETED
Last Update Posted:
2014-10-29
First Post:
2007-10-25
Brief Title:
Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
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 01 mgkgDay 02 mgkgDay 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
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALFACHIN
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 01 mgkgday and 02 mgkgday
The study consisted of 2 periods
a 12-week double blind treatment period where patients were to receive either Alfuzosin 01 mgkgday or Alfuzosin 02 mgkgday or placebo then
a 40-week open label extension treatment period where patients were to receive either Alfuzosin 01 mgkgday or Alfuzosin 02 mgkgday
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 01 mgkgday and 02 mgkgday
The study consisted of 2 periods
a 12-week double blind treatment period where patients were to receive either Alfuzosin 01 mgkgday or Alfuzosin 02 mgkgday or placebo then
a 40-week open label extension treatment period where patients were to receive either Alfuzosin 01 mgkgday or Alfuzosin 02 mgkgday
Detailed Description:
Patients who met the study entry criteria were randomized 2121 to one of the 4 dosage groups Alfuzosin 01 mgkgday matching placebo 01 mgkgday Alfuzosin 02 mgmgkg matching placebo 02 mgkgday
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-002397-38 | EUDRACT_NUMBER | None | None |