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NCT00220389 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Overactive Bladder, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 1
- Study location
NCT00220389: Completed Phase 2 study of Overactive Bladder, sponsored by Pfizer.
NCT00220389 is a Phase 2 study of Overactive Bladder that has completed, run by Pfizer. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00220389, a Phase 2 study of Overactive Bladder, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG SPM 907
Study Locations (1)
North Carolina
- Schwarz - RTP
Trial Details
| Field | Value |
|---|---|
| Start Date | 2003-06 |
| Est. Completion | 2007-06 |
| Phase | Phase 2 |
What the finished NCT00220389 record still lists
NCT00220389 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.
The record links to 1 condition, with Overactive Bladder appearing as the primary indexed condition, and to 1 intervention - of which SPM 907 is the first listed.
NCT00220389 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT00220389 about?
NCT00220389 is a clinical study titled "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 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: Su...
What is the current status of trial NCT00220389?
This trial is currently completed. It is a Phase 2 study. The study started on 2003-06. Estimated completion is 2007-06.
What conditions does trial NCT00220389 study?
This clinical trial studies the following conditions: Overactive Bladder.
What interventions are being tested in trial NCT00220389?
The interventions under investigation include: SPM 907 (DRUG).
Who is sponsoring clinical trial NCT00220389?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00220389 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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