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Two Phase Extension Trial of SP668 to Investigate the Safety and Tolerability of Sustained Release Fesoterodine in Subjects With Overactive Bladder: a Double-Blind Phase Followed by an Open-Label Extension Phase

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00220389
First Posted: September 22, 2005
Last Update Posted: October 16, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
September 14, 2005
September 22, 2005
October 16, 2008
June 2003
June 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00220389 on ClinicalTrials.gov Archive Site
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Two Phase Extension Trial of SP668 to Investigate the Safety and Tolerability of Sustained Release Fesoterodine in Subjects With Overactive Bladder: a Double-Blind Phase Followed by an Open-Label Extension Phase
Two Phase Extension Trial of SP668 to Investigate the Safety and Tolerability of Sustained Release Fesoterodine in Subjects With Overactive Bladder(OAB): a Double-Blind Phase Followed by an Open-Label Extension Phase

This extension trial of SP668 consists of two phases: double-blind treatment and open-label extension. The trial provides subjects the option of long-term treatment with sustained release (SR) fesoterodine (SPM 907) and to assess long-term subject safety, tolerability and efficacy.

Double-Blind: Subjects remained on either fesoterodine 4mg, 8mg or 12mg depending on their dose assignment in SP668. Previous SP668 placebo subjects received fesoterodine 4mg.

Open-Label: Subjects received fesoterodine 8mg with a one time option to reduce the dose to 4mg and a one time option to increase again to 8mg.

The primary variables focus on long-term safety and tolerability and include the observation and assessment of adverse events, residual urinary volumes, laboratory parameters, changes in ECG, physical and urological examinations and subject's assessment of treatment tolerance.

Secondary efficacy variables include various parameters derived from micturition diaries, count of subjects and their dose choice throughout the trial and subject's assessment of treatment efficacy.

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Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Overactive Bladder
Drug: SPM 907
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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June 2007
June 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Overactive bladder
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
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Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00220389
SP669
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Pfizer
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Study Director: Brooke Derby UCB Pharma
Pfizer
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP