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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00220402
First received: August 30, 2005
Last updated: November 21, 2008
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
Overactive Bladder Syndrome
Drug: SPM 907
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Study Start Date: July 2004
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Participated in SP583

Exclusion Criteria:

  • Failure to complete 12 week treatment with SPM 907
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00220402

Locations
Germany
Schwarz
Monheim, Germany
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Axel Steinert UCB, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00220402     History of Changes
Other Study ID Numbers: SP738
Study First Received: August 30, 2005
Last Updated: November 21, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014