- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00220389
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.
Study Overview
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
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North Carolina
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RTP, North Carolina, United States
- Schwarz
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Overactive bladder
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Brooke Derby, UCB Pharma
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SP669
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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