Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138723
Status:
COMPLETED
Last Update Posted:
2008-04-10
First Post:
2005-08-26
Brief Title:
Trial to Investigate the Efficacy Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Phase 3 Parallel Group Randomized Double-Blind Placebo Controlled Multicenter Trial to Investigate the Efficacy Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase 3 trial will investigate the efficacy tolerability and safety of fesoterodine fumarate SR fesoterodine SPM 907 in adult male and female subjects with overactive bladder syndrome The trial is a randomized double-blind placebo controlled multicenter trial
The trial consisted of a 2 week Run-In period 12 week double-blind Treatment period and 2 week Safety Follow-Up period Subjects were randomized to one of 3 treatment arms receiving either fesoterodine fumarate 4mg fesoterodine fumarate 8mg or placebo during the double-blind Treatment period
Two primary efficacy variables will be assessed for submission in the United States change in the average number of micturitions frequency per 24 hours and the change in the average number of urge incontinence episodes per 24 hours For the submissions in the European Union the first primary variable will be the change in the average number of micturitions frequency per 24 hours and the co-primary variable is the treatment response based on a treatment benefit scale All continuous variables will be measured as changes from baseline to value after 12 weeks of treatment The following safety variables were observed and assessed adverse events change in residual urinary volume mL change in laboratory parameters change in vital signs change in electrocardiogram ECG change in physical examination and change in urologicalurogynecological examination
The trial consisted of a 2 week Run-In period 12 week double-blind Treatment period and 2 week Safety Follow-Up period Subjects were randomized to one of 3 treatment arms receiving either fesoterodine fumarate 4mg fesoterodine fumarate 8mg or placebo during the double-blind Treatment period
Two primary efficacy variables will be assessed for submission in the United States change in the average number of micturitions frequency per 24 hours and the change in the average number of urge incontinence episodes per 24 hours For the submissions in the European Union the first primary variable will be the change in the average number of micturitions frequency per 24 hours and the co-primary variable is the treatment response based on a treatment benefit scale All continuous variables will be measured as changes from baseline to value after 12 weeks of treatment The following safety variables were observed and assessed adverse events change in residual urinary volume mL change in laboratory parameters change in vital signs change in electrocardiogram ECG change in physical examination and change in urologicalurogynecological examination
Detailed Description:
None
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