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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: September 14, 2005
Last updated: November 21, 2008
Last verified: November 2008

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

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long-Term Open-Label Extension Trial for Subjects Completing the Phase 3 Trial of Fesoterodine (SP584) for the Treatment of Overactive Bladder Syndrome

Resource links provided by NLM:

Further study details as provided by Pfizer:

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

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

Inclusion Criteria:

  • Overactive Bladder Syndrome
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220376

United States, North Carolina
RTP, North Carolina, United States
Sponsors and Collaborators
Study Director: Brooke Derby UCB Pharma
  More Information

ClinicalTrials.gov Identifier: NCT00220376     History of Changes
Other Study ID Numbers: SP739 
Study First Received: September 14, 2005
Last Updated: November 21, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Pathologic Processes
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Physiological Effects of Drugs
Urological Agents

ClinicalTrials.gov processed this record on May 26, 2016