A Multicenter Trial to Investigate Fesoterodine Sustained Release in Overactive Bladder Syndrome
|ClinicalTrials.gov Identifier: NCT00220363|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : May 5, 2008
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 4 treatment arms receiving either fesoterodine (SPM 907) 4mg, fesoterodine 8mg, active control (tolterodine SR 4mg) 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 most important safety variables included the assessment of adverse events, laboratory parameters, changes in ECG, physical exams and measurement of residual urine.
|Condition or disease||Intervention/treatment||Phase|
|Overactive Bladder Syndrome||Drug: SPM 907||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase 3, Parallel Group, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled Multicenter Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome|
|Study Start Date :||January 2004|
|Primary Completion Date :||February 2005|
|Study Completion Date :||February 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220363
|Study Director:||Axel Steinert||UCB Pharma|