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NCT00220376 · ClinicalTrials.gov registry record · Phase 3

Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP584) for the Treatment of Overactive Bladder Syndrome

A Phase 3 study of Overactive Bladder Syndrome, sponsored by Pfizer.

Completed
Registry status
Phase 3
Development phase
1
Study location

NCT00220376: Completed Phase 3 study of Overactive Bladder Syndrome, sponsored by Pfizer.

NCT00220376 is a Phase 3 study of Overactive Bladder Syndrome that has completed, run by Pfizer. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00220376, a Phase 3 study of Overactive Bladder Syndrome, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 3
Development phase
1
Study location

Study Summary

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 SP584 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 can be followed on an annual basis. The primary variables are long-term safety and tolerability, measured by observation and assessment of adverse events and duration on therapy. Further safety variables include the assessment of laboratory parameters, changes in ECG, physical exams and measurement of residual urine. Secondary efficacy variables included various parameters derived from micturition diaries and the evaluation of Quality of Life questionnaires

Interventions

  • DRUG SPM 907

Study Locations (1)

North Carolina

  • Schwarz - RTP

Trial Details

FieldValue
Start Date 2004-04
Est. Completion 2007-07
Phase Phase 3
Pfizer

1,845 total trials

What the finished NCT00220376 record still lists

NCT00220376 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 Syndrome appearing as the primary indexed condition, and to 1 intervention - of which SPM 907 is the first listed.

NCT00220376 reports a single indexed study location in North Carolina.

Frequently Asked Questions

What is clinical trial NCT00220376 about?

NCT00220376 is a clinical study titled "Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP584) 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 SP584 had the opportunity to participate if eligibility was confirmed. They received ...

What is the current status of trial NCT00220376?

This trial is currently completed. It is a Phase 3 study. The study started on 2004-04. Estimated completion is 2007-07.

What conditions does trial NCT00220376 study?

This clinical trial studies the following conditions: Overactive Bladder Syndrome.

What interventions are being tested in trial NCT00220376?

The interventions under investigation include: SPM 907 (DRUG).

Who is sponsoring clinical trial NCT00220376?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00220376 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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Source: ClinicalTrials.gov NCT00220376, the US trial registry maintained by the National Library of Medicine. NCT00220376 (unsized enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.