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

Overactive Bladder Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00220402
• Other study ID #: SP738
• Status: Completed
• Phase: Phase 3
• First received: August 30, 2005
• Last updated: November 21, 2008
• Start date: July 2004
• Est. completion date: July 2007

Study information

• Verified date: November 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participated in SP583

Exclusion Criteria:

• Failure to complete 12 week treatment with SPM 907

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Overactive Bladder Syndrome
• Syndrome
• Urinary Bladder, Overactive

Intervention

Drug:
• SPM 907

Locations

Country	Name	City	State
Germany	Schwarz	Monheim

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Germany,