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A Multicenter Trial to Investigate Fesoterodine Sustained Release in Overactive Bladder Syndrome

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Schwarz
Monheim, , Germany
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Bladder Syndrome
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Overactive Bladder Syndrome

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- less than 8 micturitions in 24 hours

NCT00220363
Pfizer
Completed
A Multicenter Trial to Investigate Fesoterodine Sustained Release in Overactive Bladder Syndrome

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A Multicenter Trial to Investigate Fesoterodine Sustained Release in Overactive Bladder Syndrome
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Overactive Bladder Syndrome
Drug: SPM 907
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
February 2005
February 2005   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Overactive Bladder Syndrome

Exclusion Criteria:

  • less than 8 micturitions in 24 hours
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00220363
SP583
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Axel Steinert UCB Pharma
Pfizer
April 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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Contact

[email protected]



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