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Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP583) for the Treatment of Overactive Bladder Syndrome

Last updated on October 4, 2018

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

- Participated in SP583

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

- Failure to complete 12 week treatment with SPM 907

NCT00220402
Pfizer
Completed
Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP583) for the Treatment of Overactive Bladder Syndrome

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Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP583) for the Treatment of Overactive Bladder Syndrome
Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP583) for the Treatment of Overactive Bladder Syndrome

This trial will provide long-term data on safety, satisfaction and maintenance on therapy of fesoterodine (SPM 907) in subjects with overactive bladder syndrome.

Subjects completing the 12 week treatment period of SP583 had the opportunity to participate if eligibility was confirmed. They received fesoterodine 8mg with the option to reduce the dose to 4mg during scheduled visits, and to increase again to 8mg, a procedure which could be followed on an annual basis.

Two primary efficacy variables will be assessed, which are observation and assessment of adverse events and duration on therapy.

Secondary efficacy parameters included various parameters derived from micturition diaries and the evaluation of Quality of Life questionnaires (KHQ and ICIQ-SF).

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Overactive Bladder Syndrome
Drug: SPM 907
Not Provided
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
July 2007
July 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participated in SP583

Exclusion Criteria:

  • Failure to complete 12 week treatment with SPM 907
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
 
 
NCT00220402
SP738
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Axel Steinert UCB Pharma
Pfizer
November 2008

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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